nitinol and Hyperplasia

Restenosis after percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) may occur in 45% of patients at 2 years follow-up. Paclitaxel-coated balloons have been found to reduce neointimal hyperplasia, and thus reduce restenosis. Recently, the Legflow(®) paclitaxel-coated balloon (Cardionovum Sp.z.o.o., Warsaw, Poland) (LPEB) has been introduced. This balloon is covered with shellac, a Food and Drug Administration (FDA) approved natural resin, to obtain an equally distributed tissue concentration of paclitaxel. The RAPID trial is designed to assess restenosis after PTA using the Legflow balloon combined with nitinol stenting versus uncoated balloons with nitinol stenting in SFA lesions >5 cm.. A total of 176 adult patients with Rutherford class 2 to class 6 symptoms due to intermediate (5-15 cm) or long (>15 cm) atherosclerotic lesions in the SFA will be randomly allocated for treatment with LPEB with nitinol stenting or uncoated balloon angioplasty with stenting. Stenting will be performed using the Supera(®) stent in both groups (IDEV Technologies Inc., Webster, TX). The primary endpoint is the absence of binary restenosis of the treated SFA segment. Secondary outcomes are target lesion revascularization (TLR), clinical and hemodynamic outcome, amputation rate, mortality rate, adverse events, and device-specific adverse events. Follow up consists of four visits in which ankle-brachial indices (ABI), toe pressure measurements, and duplex ultrasound (DUS) will be performed. Furthermore, a peripheral artery questionnaire (PAQ) will be completed by the patients at each follow-up. In the event that DUS reveals a symptomatic >50% restenosis, or a >75% asymptomatic restenosis, additional digital subtraction angiography will be performed with any necessary re-intervention.. The RAPID trial is a multicenter randomized controlled patient blind trial that will provide evidence concerning whether the use of the Legflow paclitaxel/shellac coated balloons with nitinol stenting significantly reduces the frequency of restenosis in intermediate and long SFA lesions compared to standard PTA and stenting.. ISRCTN47846578.

Topics: Alloys; Amputation, Surgical; Angiography, Digital Subtraction; Angioplasty, Balloon; Ankle Brachial Index; Arterial Occlusive Diseases; Cardiovascular Agents; Clinical Protocols; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Equipment Failure; Femoral Artery; Hemodynamics; Humans; Hyperplasia; Limb Salvage; Neointima; Netherlands; Paclitaxel; Predictive Value of Tests; Prosthesis Design; Prosthesis Failure; Recurrence; Research Design; Resins, Plant; Single-Blind Method; Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Access Devices

Stent design may influence the outcomes, suggesting that adverse event rates vary according to free cell area and cell design. Open cell design technology of self-expandable stents, dedicated for carotid revascularisation has better deliverability, although closed cell technology is expected to cause fewer thromboembolic events.. To evaluate the feasibility and vascular response of novel, hybrid cell, self-expandable nitinol stents (MER®, Balton, Poland) implanted into porcine carotid arteries. Hybrid cell design combines open and closed cell technology.. All tested stents were implanted with 10% overstretch into 10 carotid segments of Polish domestic pigs. Control angiography was obtained immediately before and after vascular interventions as well as 28 days after the procedure. Thereafter, animals were sacrificed, and the treated segments were harvested and evaluated in the independent histopathology laboratory.. All stents were easily introduced and implanted, showing good angiographic acute outcome. At 28 days, in the angiography, all vessels were patent with no signs of thrombi or excessive neointimal formation, with the late lumen loss of -0.11 ± 0.3 mm and percentage diameter stenosis 10.18 ± 8.1%. There was a 10% increase in the vessel reference diameter when compared to baseline (4.57 ± 0.5 vs. 4.96 ± 0.3 mm, p < 0.01). In the histopathology, mean area stenosis was 17.4% and mean intimal thickness was 0.20 mm. At histopathology, the mean injury, inflammation, and fibrin scores were low. Endothelialisation was complete in all stents, and neointimal tissue appeared moderately mature as shown by the moderate mean neointimal smooth muscle score. Nonetheless, histopathology shows one stent affected by peri-strut granulomas and one stent affected by marked mineralisation.. The novel Polish self-expandable nitinol carotid stent with hybrid cell technology shows optimal biocompatibility and a vascular healing profile, and therefore may be introduced for first-in-man application.

Topics: Alloys; Angioplasty; Animals; Carotid Arteries; Carotid Stenosis; Hybrid Cells; Hyperplasia; Materials Testing; Models, Animal; Neointima; Patient Safety; Prosthesis Design; Stents; Sus scrofa

This study sought to compare the local tissue response and subsequent volume of intimal hyperplasia (IH) that develops throughout the maturation of an arteriovenous fistula created using continuous/interrupted polypropylene with that of a novel, metal-alloy, penetrating anastomotic clip device.. Forty-six fistulae were created in 23 sheep under a paired design using the nitinol U-Clip (n = 23) in one hind limb and continuous (n = 20) or interrupted (n = 3) polypropylene suture for the other. Animals were killed at 4 (n = 3), 14 (n = 3), 28 (n = 10), 42 (n = 3), and 180 (n = 4) days. Histological sections were evaluated for quantitative histology and immunohistochemistry.. Compared with continuous polypropylene, U-Clip specimens demonstrated less intima-media area per unit length (IMA/L), proliferating cells, and tissue necrosis at all time points (MANOVA, F = 9.8-24.1, all p ≤ .005; observed power >82%). Specifically, values of IMA/L were reduced by 5% (p = .97), 37% (p = .02), 33% (p < .01), 9% (p = .42), and 14% (p = .22) at the time points of 4, 14, 28, 42, and 180 days respectively. Proliferating cells were reduced by 75% (p < .01), 72% (p = .03), 76% (p = .03), 27% (p = .31), and 60% (p = .01) and tissue necrosis by 67% (p < .01), 58% (p = .02), 40% (p = .33), 21% (p = .43), 77% (p = .11). In a 28-day comparison between U-Clip and interrupted polypropylene the U-Clip group demonstrated a 4% (p = .65) reduction in IMA/L, 74% (p < .01) in proliferating cells and 49% (p < .05) in tissue necrosis.. These results provide evidence of reduced local tissue necrosis, proliferating cells, and IH, favouring arteriovenous fistulae created using the U-Clip anastomotic device over conventional polypropylene suture techniques most evident over the first 4 weeks.

Topics: Alloys; Animals; Arteriovenous Shunt, Surgical; Cell Proliferation; Equipment Design; Femoral Artery; Femoral Vein; Hindlimb; Hyperplasia; Models, Animal; Muscle, Skeletal; Necrosis; Neointima; Polypropylenes; Sheep; Surgical Instruments; Suture Techniques; Sutures; Time Factors

The aim of this study was to create an ovine arteriovenous fistula (AVF) model which would closely replicate a human forearm fistula and use this to quantify the degree of intimal hyperplasia in those created with the U-Clip compared to a conventional sutured anastomosis.. Twenty AVFs were created in 10 Border Leicester-Merino sheep between the superficial femoral artery and vein of each hind limb. On one side the U-Clip and on the other a continuous polypropylene suture was used to perform the anastomosis. The animals were sacrificed at 2 (n = 3), 4 (n = 4), 6 (n = 3) weeks and histological slices were taken of each AVF in cross section to determine the intimal media area per unit length (IMA/L).. Intimal hyperplasia (IH) was observed at all time points with one AVF found occluded with thrombus at the time of harvest. The IMA/L was significantly lower in the U-Clip groups by 24% at 2 weeks, 32% at 4 weeks and 23% at 6 weeks (Two-way ANOVA, p = 0.019, observed power = 0.825, time or side p ≥ 0.766, type p = 0.001; Paired t-test, p < 0.001 between matched anastomotic types). Time taken to perform the anastomosis was similar between the two anastomotic techniques (Polypropylene 14(8-18) vs. U-Clip 15.3(11-23) min; p = 0.47).. This ovine AVF model results in IH similar to that seen in a human AVF. The IH that occurs with the U-Clip is less than that of continuous polypropylene suture.

Topics: Alloys; Anastomosis, Surgical; Animals; Arteriovenous Fistula; Disease Models, Animal; Hyperplasia; Sheep; Surgical Instruments; Sutures; Tunica Intima

Neointimal hyperplasia is a major complication of endovascular stent placement with consequent in-stent restenosis or occlusion. Improvements in the biocompatibility of stent designs could reduce stent-associated thrombosis and in-stent restenosis. We hypothesised that the use of a diamond-like carbon (DLC)-coated nitinol stent or a polyethylene glycol (PEG)-DLC-coated nitinol stent could reduce the formation of neointimal hyperplasia, thereby improving stent patency with improved biocompatibility.. A total of 24 stents were implanted, under general anaesthesia, into the iliac arteries of six dogs (four stents in each dog) using the carotid artery approach. The experimental study dogs were divided into three groups: the uncoated nitinol stent group (n = 8), the DLC-nitinol stent group (n = 8) and the PEG-DLC-nitinol stent group (n = 8).. The mean percentage of neointimal hyperplasia was significantly less in the DLC-nitinol stent group (26.7±7.6%) than in the nitinol stent group (40.0±20.3%) (p = 0.021). However, the mean percentage of neointimal hyperplasia was significantly greater in the PEG-DLC-nitinol stent group (58.7±24.7%) than in the nitinol stent group (40.0±20.3%) (p = 0.01).. Our findings indicate that DLC-coated nitinol stents might induce less neointimal hyperplasia than conventional nitinol stents following implantation in a canine iliac artery model; however, the DLC-coated nitinol stent surface when reformed with PEG induces more neointimal hyperplasia than either a conventional or DLC-coated nitinol stent.

Topics: Alloys; Animals; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Dogs; Hyperplasia; Iliac Artery; Neointima; Polyethylene Glycols; Stents

Constriction of vein grafts with braided external nitinol meshes had previously led to the successful elimination of neointimal tissue formation. We investigated whether pulse compliance, smaller kink-free bending radius, and milder medial atrophy can be achieved by knitting the meshes rather than braiding, without losing the suppressive effect on intimal hyperplasia.. Pulse compliance, bending stiffness, and bending radius, as well as longitudinal-radial deformation-coupling and radial compression, were compared in braided and knitted nitinol meshes. Identical to previous studies with braided mesh grafts, a senescent nonhuman primate model (Chacma baboons; bilateral femoral interposition grafts/6 months) mimicking the clinical size mismatch between vein grafts and runoff arteries was used to examine the effect of knitted external meshes on vein grafts: nitinol mesh-constricted (group 1); nitinol mesh-constricted and fibrin sealant (FS) spray-coated for mesh attachment (group 2); untreated control veins (group 3), and FS spray-coated control veins (group 4).. Compared with braided meshes, knitted meshes had 3.8-times higher pulse compliance (3.43 ± 0.53 vs 0.94 ± 0.12%/100 mm Hg; P = .00002); 30-times lower bending stiffness (0.015 ± 0.002 vs 0.462 ± 0.077 Nmm(2); P = .0006); 9.2-times narrower kink-free bending radius (15.3 ± 0.4 vs 140.8 ± 22.4 mm; P = .0006), and 4.3-times lower radial narrowing caused by axial distension (18.0% ± 1.0% vs 77.0% ± 3.7%; P = .00001). Compared with mesh-supported grafts, neointimal tissue was 8.5-times thicker in group I (195 ± 45 μm) vs group III (23.0 ± 21.0 μm; P < .001) corresponding with a 14.3-times larger neointimal area in group I (4330 ± 957 × 103 μm(2)) vs group III (303 ± 221× 103 μm(2); P < .00004). FS had no significant influence. Medial muscle mass remained at 43.4% in knitted meshes vs the 28.1% previously observed in braided meshes.. Combining the suppression of intimal hyperplasia with a more physiologic remodeling process of the media, manifold higher kink-resistance, and lower fraying than in braided meshes makes knitted nitinol an attractive concept in external vein graft protection.

Topics: Alloys; Animals; Biomechanical Phenomena; Compliance; Equipment Design; Femoral Artery; Femoral Vein; Fibrin Tissue Adhesive; Hyperplasia; Materials Testing; Microscopy, Electron, Scanning; Models, Animal; Papio ursinus; Pulsatile Flow; Surgical Mesh; Time Factors; Vascular Grafting

Constrictive external Nitinol meshes have been shown to suppress neointimal tissue formation and preserve endothelial integrity in vein grafts. As this mitigating effect increased with the degree of constriction, we investigated whether extreme constriction was possible without leading to detrimental luminal encroachment.. A senescent non-human primate model (Chacma baboons/bilateral femoral interposition grafts) mimicking the clinical size-mismatch between vein grafts and run-off arteries was used. Control grafts were either untreated (group 1) or spray-coated with fibrin glue (group 2). Nitinol meshes constricting the lumen by 90% (group 4). Anastomotic size mismatch at implantation was expressed as quotient of cross-sectional area of run-off artery to vein graft (Q(C)).. At 6 months, all vein grafts without mesh support showed thick eccentric layers of neointimal tissue (group 1: 348 +/- 130 microm [Q(C) median at implant 0.19]; group 2: 318 +/- 142 microm [Q(C) median at implant 0.17]). Fibrin glue-spraying had no effect. In contrast, neointimal tissue was absent in all mesh-supported grafts (P < .007 in all cases) both at 6 weeks/6 months (group 3: 7.5 +/- 8.8 mum and 2.5 +/- 4.4 microm [Q(C) median at implant 1.47]; group 4: 1.3 +/- 0.6 microm and 3.8 +/- 5.6 microm [Q(C) median at implant 3.09]). Except for mild tissue buckling (fold height <356 microm) in one group 3 graft, none of the mesh-constricted grafts showed wall folds. Endothelial coverage was only complete in the mesh-supported groups (100% in group 3 and 4 vs 85 +/- 14%; P < .023 in group 1). Fibrin glue alone (52 +/- 48%) did not preserve endothelialization of control grafts (P < .38).. Extreme vein graft constriction using external Nitinol meshes is possible without detrimental tissue buckling. Although moderate constriction was found to be sufficient for mitigating diffuse intimal hyperplasia and endothelial detachment, extreme constriction may occasionally be required to eliminate luminal irregularities.

Topics: Alloys; Anastomosis, Surgical; Animals; Constriction; Endothelial Cells; Equipment Design; Femoral Artery; Femoral Vein; Fibrin Tissue Adhesive; Hyperplasia; Models, Animal; Papio ursinus; Regional Blood Flow; Surgical Mesh; Time Factors; Tissue Adhesives; Tunica Intima; Tunica Media; Vascular Patency; Vascular Surgical Procedures

External mesh support of vein grafts has been shown to mitigate the formation of intimal hyperplasia. The aim of the present study was to address the issue of optimal mesh size in a nonhuman primate model that mimics the dimensional mismatch typically encountered between clinical vein grafts and their target arteries.. The effect of mesh size on intimal hyperplasia and endothelial preservation was assessed in bilateral femoral interposition grafts in Chacma baboons (n(Sigma) = 32/n = 8 per mesh size). No mesh support (group I) was compared with external nitinol meshes at three different sizes: loose fitting (group II), 25% diameter constricting (group III), and 50% diameter constricting (group IV). Mesh sizes were seen not only in isolation but also against the background of anastomotic size mismatch at implantation, expressed as quotient of cross-sectional area of host artery to vein graft (Q(C)).. Significant amounts of intimal hyperplasia were found in group I (Q(C) median 0.20; intimal hyperplasia 6 weeks = 1.63 +/- 0.34 mm(2); intimal hyperplasia 12 weeks = 1.73 +/- 0.5 mm(2)) and group II (Q(C) median 0.25; intimal hyperplasia 6 weeks = 1.96 +/- 1.64 mm(2); intimal hyperplasia 12 weeks = 2.88 +/- 1.69 mm(2)). In contrast, group III (Q(C) median 0.45; intimal hyperplasia 6 weeks = 0.08 +/- 0.13 mm(2); intimal hyperplasia 12 weeks = 0.18 +/- 0.32 mm(2)) and IV (Q(C) median 1.16; intimal hyperplasia 6 weeks = 0.02 +/- 0.03 mm(2); intimal hyperplasia 12 weeks = 0.11 +/- 0.10 mm(2)) showed dramatically suppressed intimal hyperplasia (P < .01) at both time points. Endothelial integrity was only preserved in group IV (P < .05). There were no significant differences in vascularization and inflammation in either interlayer or intergroup comparisons.. By using an animal model that addressed the clinical phenomenon of diameter discrepancy between vein graft and bypassed artery, we could demonstrate that suppression of intimal hyperplasia required constrictive mesh sizes.

Topics: Alloys; Animals; Blood Vessel Prosthesis; Constriction; Hyperplasia; Papio; Prosthesis Design; Tunica Intima; Vascular Patency; Veins

To compare aortic intimal thickening of normal and hyperhomocysteinemic pigs (induced with a methionine-rich diet) following placement of a self-expanding nitinol stent.. Eighteen Macau pigs were used. They were older than eight weeks in age and had an average weight of 30 kg. Pigs were randomly divided into two groups. The first, Group C (control), was fed a regular diet, and the second group, Group M, was fed a methionine-rich diet for 30 days to induce hyperhomocysteinemia. The self-expandable nitinol stents were 25mm in length and 8 mm in diameter after expansion. Blood samples were collected to measure total cholesterol, triglycerides, HDL and homocysteine concentrations. All animals were subjected to angiography. Thirty days after the procedure, the animals were sacrificed, and the abdominal aorta was removed for histological and digital morphometry analysis.. Under microscopic evaluation, the intima was significantly thicker in Group C than in Group M. When groups were compared by digital morphometric analysis, intimal thickening of the vessel wall was higher in Group C than in Group M. There was no significant change in total cholesterol, triglycerides or HDL concentrations in either group. In group C the levels of plasma homocysteine ranged from 14,40 to 16,73 micromol/l; in Group M, plasma homocysteine levels ranged from 17.47 to 59.80 micromol/l after 30 days of a methionine-rich diet.. Compared to normal pigs, less intimal hyperplasia was observed in the abdominal aortas of hyperhomocysteinemic pigs thirty days after the insertion of a self-expandable nitinol stent.

Topics: Alloys; Animals; Aorta; Aorta, Abdominal; Atherosclerosis; Biocompatible Materials; Cholesterol, HDL; Coronary Restenosis; Diet, Atherogenic; Disease Models, Animal; Hyperhomocysteinemia; Hyperplasia; Random Allocation; Stents; Swine; Triglycerides; Tunica Intima

The purpose of this study was to evaluate the long-term effects of the DEVAX AXXESS biolimus eluting stent (BES) in a porcine coronary model, compared with those of bare metal stent (BMS) and polymer only stent (POS) controls.. Excessive neointimal growth has been identified as a major cause of late failure of percutaneous coronary interventions. The effect of drug eluting from self-expanding stents for prevention of neointimal hyperplasia has not been studied before. The DEVAX AXXESS is a self-expanding nickel titanium stent, coated with antiproliferative compound-biolimus.. Twenty juvenile farm swine, 25-35 kg in weight, 3-6 months in age were used. Each animal received a stent to the left anterior descending artery, left circumflex or right coronary arteries as permitted per anatomy. The chronic vascular response after BES implantation was compared with that after BMS and POS implantation at 28, 90, and 180 days follow-up.. The 28-day outcome by quantitative coronary angiography (QCA) showed significant increase in minimal luminal diameter (MLD) in the BES (MLD: 2.90 +/- 0.97, 2.39 +/- 0.90, 1.59 +/- 0.91; P = 0.009) compared with BMS and POS, respectively. By histomorphometric analysis, there was also a corresponding significant reduction in neointimal tissue proliferation in the BES (average neointimal area: 2.78 +/- 0.07, 5.46 +/- 0.66, 8.42 +/- 0.85; P = 0.002) compared with that in BMS and POS controls, respectively at 28-days follow-up. At 90 and 180 days, the mean neointimal area was not significantly different between the BES and the controls.. BES favorably modulates the neointimal tissue formation for 28 days, in the porcine coronary model. Long-term inhibition of neointimal hyperplasia is not sustained most likely because of the delayed cellular proliferation and inflammation in the vessel wall.

Topics: Alloys; Animals; Coated Materials, Biocompatible; Coronary Angiography; Hyperplasia; Immunosuppressive Agents; Models, Animal; Polyesters; Prosthesis Design; Sirolimus; Stents; Swine; Time Factors; Tunica Intima

To compare the biocompatibility and performance of various stent-grafts to those of a bare stent in an ovine model with a subchronic (3 months) endpoint.. Three different types of stent-grafts (ePTFE/nitinol, n = 8; polyester/nitinol, n = 8; and polycarbonate urethane/cobalt-alloy, n = 8) and a bare stent as a control (Ni-Co-Ti-steel-alloy, n = 8) were implanted in the iliac arteries in eight female sheep. One type of each stent-graft was implanted per animal, two implants at each side. The implantation sites for each type varied from animal to animal. Angiographic control and intravascular ultrasound (IVUS) imaging were performed before and after implantation, after 2 months, and before explantation at 3 months and were used to characterize patency and to assess intimal hyperplasia. After 3 months, the implants were retrieved and subjected to histologic evaluation (after methacrylate embedding, cutting, and histologic staining) to characterize the biologic response.. Implantation was technically successful in all procedures. At 2 and 3 months after implantation, all segments in which stents had been implanted were patent. Marked neointima formation was found in the polyester-covered stent-graft that showed significant luminal narrowing of 50%, compared to the ePTFE-covered (24%) and polycarbonate urethane-covered endoprostheses (22%), as well as the bare stent (Wallstent; 9%; P < .001). A minimal inflammatory vessel wall reaction was demonstrated for the polyester-covered and ePTFE-covered endoprostheses; the polycarbonate urethane-covered stent-graft's response was demonstrable but not significantly different from that of the Wallstent. At 3 months, the ePTFE-covered stent-graft showed incomplete (>90%) endothelial coverage; in the other endoprostheses, complete but partially immature endothelialization was found.. All stent-grafts induced an inflammatory vessel wall reaction with neointimal hyperplasia. The polyester-covered endoprosthesis caused a marked reaction with 50% luminal stenosis. Endothelialization was retarded with the ePTFE-covered stent-graft. The bare stent performed best in regard to neointimal formation and caused the least inflammatory response.

Topics: Alloys; Animals; Biocompatible Materials; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Female; Hyperplasia; Iliac Artery; Polyesters; Polytetrafluoroethylene; Sheep; Stents; Time Factors; Tunica Intima; Vascular Patency

To assess whether the use of a prosthesis covered by a Dacron sheath might prevent pseudointimal hyperplasia in a transjugular intrahepatic portosystemic shunt (TIPS).. A TIPS procedure was performed in nine pigs, after creation of a portal vein microembolization model of portal hypertension, by using a Dacron-covered nitinol stent. The first centimeter on the lower extremity of this specially made prototype was uncovered, to avoid portal vein thrombosis. Three weeks later, the seven surviving animals underwent transjugular hemodynamic and angiographic follow-up and were then killed for gross and histologic evaluation.. Shunt insertion was possible in all pigs; two died of complications of the procedure. After 3 weeks only two shunts were patent, although a 50%-60% narrowing of the initial portion of the shunt was present; the remaining shunts were occluded. Histologic examination showed pseudointimal hyperplasia associated, in the cases of occlusion, with a luminal thrombosis.. This Dacron-covered stent did not prevent pseudointima formation over the stent and resulted in a high early occlusion rate, probably related to a pronounced tissue fibrotic response likely due to Dacron-induced inflammation.

Topics: Alloys; Angiography; Animals; Disease Models, Animal; Embolism; Equipment Design; Fibrosis; Follow-Up Studies; Graft Occlusion, Vascular; Hemodynamics; Hepatic Artery; Hyperplasia; Hypertension, Portal; Polyethylene Terephthalates; Portal Vein; Portasystemic Shunt, Transjugular Intrahepatic; Stents; Surface Properties; Survival Rate; Swine; Thrombosis; Tunica Intima; Vascular Patency

We sought to investigate the acute and long-term patency rates and the histologic response of coronary arteries to a self-expandable nitinol coil stent. Twenty-two stents were implanted. Angiographic patency was demonstrated acutely in all but one dog, in which the stent was released in a small branch (1 mm); mismatch in stent-to-artery diameters resulted in vessel closure. Two dogs died from anesthesia overdose and two from bleeding within 24 hours. All dogs were treated with aspirin (80 mg/day) and warfarin (2.5 mg/day) for up to 1 month. Sixteen dogs were monitored for 1 to 2 weeks, 1 month, 3 months, 6 months, and 1 year and underwent subsequent angiography and histopathologic examination. Angiographic artery dimensions measured immediately after stent implantation (2.72 +/- 0.4 mm) did not differ from those noted at follow-up (2.68 +/- 0.44 mm, p not significant). Histologic examination showed outward stent pressure compressing the internal elastic membrane and media in most cases. Intimal hyperplasia started at 2 weeks and was most apparent at 3 and 6 months. Mean intimal thickness was 30.7 +/- 10.9 mu, 141.8 +/- 105.4 mu, 227.1 +/- 104.1 mu, 211.8 +/- 99.1 mu, and 170.1 +/- 42.7 mu at 1 to 2 weeks and 1, 3, 6 and 12 months, respectively. Therefore the nitinol self-expandable stent provokes a moderate cellular proliferative response that reaches its maximum in 3 to 6 months without further progression.

Topics: Alloys; Animals; Coronary Angiography; Coronary Vessels; Dogs; Equipment Design; Hyperplasia; Stents; Time Factors; Tunica Intima; Vascular Patency