10 Clinical Trials for Various Conditions
Angioplasty and stenting for atherosclerotic occlusive disease in the arteries supplying the legs (Peripheral Arterial Disease, PAD) is the most common endovascular procedure outside of the heart, but carries the highest rate of reconstruction failure. The underlying reasons for these poor results are not completely clear, but the main arterial segment within the leg, the femoropopliteal artery, appears to be significantly different from other peripheral arteries because the Superficial Femoral Artery (SFA) and Popliteal Artery (PA) that comprise the femoropopliteal artery (FPA) segment, undergo large deformations during flexion of the limb. We propose to build mathematical models of human FPAs repaired with several frequently used PAD stents. These mathematical models would be able to assess the mechanical stress in the stented SFA and PA associated with limb flexion and predict disease recurrence for arteries with different patient and lesion characteristics. Results of model predictions will be validated in patients with PAD stents who have received these stents as part of their standard of care.
To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).
Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads to improved overall results compared to balloon angioplasty alone. However, scar tissue development can occur within the stent, a process called restenosis. Treatment of these in-stent restenotic lesions has a high procedural success rate but recurrence of scar tissue is frequently seen. Several methods have been proposed to treat in-stent restenosis in the lower leg arteries but mixed results have been noted. In this study we hypothesize that simultaneous tissue excision and aspiration using the JetStream Navitus device (Medrad) can lead to a high rate of acute procedural success with low intraprocedural complications and an acceptable recurrence rate of restenosis at 6-month follow-up.
The purpose of this study is to test the hypothesis that Jetstream atherectomy (JS) and adjunctive balloon angioplasty (PTA) (JS +PTA) improves target lesion revascularization (TLR) at 6 months follow-up when compared to historic data from PTA alone in the treatment of femoropopliteal (FP) arterial In-stent restenotic (ISR) disease. This is a prospective, multicenter, single arm study evaluating the investigational use of Jetstream Atherectomy (JS) and adjunctive balloon angioplasty (JS +PTA) in the treatment of FP ISR lesions in subjects with claudication or limb ischemia (Rutherford clinical category (RCC) of 2-4) (lesion length ≥ 4 cm). The comparator arm is historic data from plain old balloon angioplasty derived from a Meta-analysis of the 3 published randomized trials in the field.
This is a clinical study of a new self-expanding stent (FlexStent®) designed specifically to cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal artery. The arteries are often abbreviated as femoropopliteal. The intent of this study is to demonstrate that the FlexStent® Femoropopliteal Self-Expanding Stent System is safe and effective for the treatment of patients with peripheral arterial disease. Specifically, the FlexStent® shall meet or exceed the proposed safety and efficacy performance goals established for Femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease.
A retrospective study to evaluate Turbo Power laser atherectomy + drug coated balloon (DCB) angioplasty for the treatment of femoropopliteal de novo/restenotic lesions and in-stent restenosis (ISR).
The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel diameter) for lesions up to 7 cm long. The clinical trial is stratified by lesion length. The trial will be conducted in 2 phases, with Phase 1 enrolling patients with lesions less than 7 cm long. Phase 2 of the trial will include longer lesions (up to 14 cm long) and will be initiated upon approval by the Food and Drug Administration (FDA).
The purpose of this study is to assess the safety and efficacy of administering intra-arterial paclitaxel in the femoropopliteal arteries via the TAPAS catheter following percutaneous revascularization to prevent restenosis.
A retrospective review with four year followup on patients that had previously been enrolled in a study to evaluate blockages in the lower legs. The study looked at patients that had undergone a bypass of the leg from the groin to the knee area with an incision in each area using general anesthesia. These patients were compared to others who had undergone treatment with balloon dilatation and stents in the arteries in the thighs with only numbing medicine. The study was completed two years ago and was initially designed to look at outcomes at 24 months. Now the investigators are trying to go back and look at outcomes of these patients' treatment at 4 years by simply reviewing their records.
This study is a comparison of two different ways to treat blockage in the artery of the thigh. The first is an older way with incisions in the groin and just above the knee. A plastic tube is then inserted to make a bypass from the groin to the knee. The second treatment offered is through a needle hole in the groin. A thin plastic tube covering a metal stent is inserted into the artery and released to bypass the blockage from inside the artery. No incisions are needed. Patients are enrolled and then selected for one treatment method or another by chance. The patients will be followed for two years to see how the two different treatment methods work compared to each other.