nitinol and Intracranial-Arteriosclerosis

Topics: Alloys; Clinical Trials as Topic; Humans; Intracranial Arteriosclerosis; Stents; Treatment Outcome

Angioplasty and stenting using nitinol stents is a recognized treatment option for intracranial atherosclerosis.. To identify procedure-related factors that may affect patient safety and technical outcome.. In this prospective study of 57 consecutive patients, the primary end points were intraprocedural technical problems, periprocedure morbidity, and complications. Major periprocedure complication was defined as all stroke or death at 30 days. Technical failure was defined as the inability to complete the procedure because of technical or safety problems. Procedure failure was defined as a procedure outcome of technical failure or major periprocedure complication. Secondary end points were procedure-related factors that may affect patient safety and technical outcome.. Procedure failure rate was 12.3% (7/57) (major periprocedure complication rate, 5.3% [3/57]; technical failure rate, 7% [4/57]). Initial failure in tracking of balloon or stent occurred in 20 patients, other technical problems occurred in 11 patients, including kinking or trapping of balloon catheter (2 cases), difficulty in unsheathing of stent (3 cases), forward migration of stent during deployment (4 cases), trapping of nose cone after stent deployment (1 case), fracture of delivery system (2 cases), and guidewire fracture (1 case). Unfavorable vascular morphology signified by the presence of 2 or more reverse curves along the access path was found to associate with initial failure in the tracking of instruments (OR = ∞), and occurrence of other technical problems (OR = 25).. Procedure-related factors could be identified and lead to improvements in patient safety and technical outcome. Tortuous vascular morphology is a key factor to be overcome.

Topics: Aged; Alloys; Angioplasty; Angioplasty, Balloon; Cerebral Arteries; Constriction, Pathologic; Equipment Failure; Female; Humans; Intracranial Arteriosclerosis; Male; Middle Aged; Patient Safety; Postoperative Complications; Process Assessment, Health Care; Prospective Studies; Radiography; Stents; Treatment Outcome

The purpose of this study was to assess the safety and performance of the Wingspan stent system and Gateway percutaneous transluminal angioplasty balloon catheter in the treatment of high-grade, intracranial atherosclerotic lesions in patients who had failed medical therapy.. In this prospective, multicenter, single-arm study, medically refractory patients with a modified Rankin score < or =3 and recurrent symptoms attributable to angiographically demonstrated intracranial stenosis > or =50% in a vessel 2.5 to 4.5 mm in diameter were enrolled. Intracranial lesions were predilated with an undersized Gateway balloon catheter to 80% of the native vessel diameter, followed by deployment of the self-expanding Wingspan stent to facilitate further remodeling of the atherosclerotic plaque and to maintain vessel patency. Neurologic examinations and angiograms were performed at 6 months after the procedure.. Among the 45 patients enrolled, the degree of stenosis was reduced from a baseline of 74.9+/-9.8% to 31.9+/-13.6% after stenting and 28+/-23.2% at the 6-month follow-up. The 30-day composite ipsilateral stroke/death rate was 4.5% (2/44); at the 6-month follow-up, the ipsilateral stroke/death rate was 7.0%, the rate for all strokes was 9.7%, and all-cause mortality was 2.3%. Physician-reported follow-up in 43 patients (average of 13 months) conducted outside the study protocol (not adjudicated by the clinical event committee) reported 1 additional ipsilateral stroke.. In medically refractory patients with high-grade intracranial atherosclerotic stenoses, a new treatment paradigm involving predilation with an undersized Gateway percutaneous transluminal angioplasty balloon catheter and placement of a self-expanding Wingspan stent system appears to be safe, may facilitate remodeling, and may contribute to favorable angiographic outcomes.

Topics: Aged; Alloys; Angioplasty, Balloon; Female; Humans; Intracranial Arteriosclerosis; Male; Prospective Studies; Stents; Treatment Outcome