glycerol and Peripheral Arterial Disease

glycerol has been researched along with Peripheral Arterial Disease in 1 studies

Moon: The natural satellite of the planet Earth. It includes the lunar cycles or phases, the lunar month, lunar landscapes, geography, and soil.

Peripheral Arterial Disease: Lack of perfusion in the EXTREMITIES resulting from atherosclerosis. It is characterized by INTERMITTENT CLAUDICATION, and an ANKLE BRACHIAL INDEX of 0.9 or less.

Research

Studies (1)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Number of Participants Free From Major Adverse Events (MAE)

The primary safety endpoint assesses freedom from major adverse events (MAE) at 12 months post-procedure. (MAE is defined as: above ankle amputation in index limb; major re-intervention; and perioperative (30 day) mortality) (NCT03551496)
Timeframe: 12 months

Number of Participants Who Were Admitted to the Hospital Within 30 Days After the Index Procedure.

Hospitalizations related to Critical Limb Ischemia (CLI) due to target lesion revascularization (TLR)/target vessel revascularization (TVR) or Target Limb Major Amputation or Procedure/Device related Adverse Events (NCT03551496)
Timeframe: Up to 30 days post procedure

Number of Participants With Assisted Primary Patency

Assisted primary patency defined as the percentage (%) of lesions without clinically-driven TLR and those with clinically-driven TLR (not due to complete occlusion or by-pass) which show flow by DUS without restenosis. (NCT03551496)
Timeframe: 12 months post procedure

Number of Participants With Baseline Wounds Assessed as Healed

Wounds assessed for healed status by Independent Wound Assessors, blinded to randomized treatment. (NCT03551496)
Timeframe: 12 months post procedure

Number of Participants With Clinically Driven Target Lesion Revascularization

"Clinically-driven target lesion revascularization is defined as any surgical or percutaneous intervention to the target lesion after the index procedure if:~Occurring within 5mm proximal or distal to the original treatment segment with diameter stenosis ≥50% by quantitative angiography and if participant has recurrent symptoms OR~In-lesion diameter stenosis less than 50% might also be considered a MAE by the CEC if the subject has recurrent symptoms.~Recurrent symptoms are defined as having ≥ 1 change in Rutherford Classification or associated with decreased ABI/TBI of ≥20% or ≥ 0.15 in the treated segment." (NCT03551496)
Timeframe: 12 months post procedure

Number of Participants With Hemodynamic Improvement

Hemodynamic improvement is defined as improvement of ankle-brachial index (ABI) by ≥0.10 or to an ABI ≥0.90 as compared to pre-procedure value without the need for repeat revascularization. (NCT03551496)
Timeframe: 12 months post procedure

Number of Participants With Major Amputation (Defined as Amputation of the Lower Limb at the Ankle Level or Above)

Rates of amputation of the lower limb at the ankle level or above (NCT03551496)
Timeframe: 12 months post procedure

Number of Participants With Primary Patency

Twelve-Month Primary Patency defined as a binary endpoint to be determined via duplex ultrasound (DUS) measuring flow at the 12-month follow-up visit, in the absence of clinically-driven target lesion revascularization (TLR) or bypass of the target lesion. Data table consists of the number of participants with flow as assessed by DUS. (NCT03551496)
Timeframe: 12 months

Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline

"Endpoint determined to be a success when there is an improvement in Rutherford Classification of one or more categories as compared to pre-procedure without the need for repeat TLR. Rutherford Classifications:~i. Category 0 - Asymptomatic ii. Category 1 - Mild claudication iii. Category 2 - Moderate claudication iv. Category 3 - Severe claudication v. Category 4 - Ischemic rest pain vi. Category 5 - Minor tissue loss - nonhealing ulcer, focal gangrene vii. Category 6 - Major tissue loss - extending above transmetatarsal (TM) level" (NCT03551496)
Timeframe: 12 months post procedure

Number of Participants With Major, Serious, Non-serious, Unanticipated, Device-related and Procedure-related Adverse Events

Adverse events (AEs) to be classified as major (defined as above ankle amputation of the index limb, major re-intervention (new bypass graft, jump/interposition graft, or thrombectomy/thrombolysis) and perioperative (30 day) mortality), serious, non-serious, unanticipated, procedure-related and device-related. (NCT03551496)
Timeframe: 12 months post procedure

Participant Quality-of-Life Changes Via EuroQol 5 Dimension (EQ-5D) Questionnaire.

The EQ-5D is a descriptive system of health-related quality-of-life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 5 responses. The responses record 5 levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension). The levels are assigned a numeric code 1-5 (eg, 1= no problems and 5= extreme problems). (NCT03551496)
Timeframe: 12 months post procedure

Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire.

Changes in quality of life is measured using the Vascular Quality of Life (VascuQol) questionnaire, which is a 25 item questionnaire used to measure the quality-of-life in patients with lower limb ischemia. The tool is sub-divided into 5 domains: pain, symptoms, activities, social and emotional. (NCT03551496)
Timeframe: 12 months post procedure

Reviews

1 review available for glycerol and Peripheral Arterial Disease