Active clinical trials for "Peripheral Vascular Diseases"

This study is designed to examine the added benefits of weight loss to an exercise program in older obese Veterans with peripheral arterial disease. The investigators want to determine if weight loss in addition to exercise will 1) improve walking ability to a greater extent than exercise alone and 2) determine the underlying reasons why walking ability improves by measuring blood flow and the amount of muscle in the leg muscles.

DVC1-0101 is a gene therapy medicine to treat peripheral arterial disease (PAD) based on recombinant F-gene-deleted, non-transmissible Sendai virus (rSeV/dF) expressing human fibroblast growth factor-2 (FGF-2) gene. The primary objective of the current Phase IIb study is to investigate the clinical efficacy of DVC1-0101 (1x10^9 ciu/leg, 5x10^9 ciu/leg) in patients with IC.

The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vessel (HAV). The HAV is intended as an alternative to synthetic materials and to autologous grafts in the creation of an above-knee femoro-popliteal bypass graft in patients with peripheral arterial disease.

The Auryon Laser Atherectomy System has been cleared by the FDA to treat infrainguinal arterial disease including in-stent restenosis

Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) and decreased blood flow to the legs. This may cause difficulty or pain with walking or other activities that use leg muscles. Exercise may help improve blood flow in the legs and improve the ability to walk. This research project will be conducted patients with PAD that require revascularization. The goal is to examine the effects of 3 months of exercise rehabilitation or neuromuscular stimulation on leg blood flow, physical function, quality of life and general health.

Prospective, single-arm, multi-center, international clinical investigation to evaluate the safety and effectiveness of the PQ Bypass System to access, deliver guidewires, and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.

The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the StellarexTM 0.014" OTW Drug-coated Angioplasty Balloon in the treatment of lesions in "below the knee" popliteal (P3 segment) and infra-popliteal arteries according to the Instructions for Use in Rutherford-Becker Classification (RCC) 3, 4 and 5 patient populations. This study will be conducted in Europe across up to 10 centers in up to 75 subjects. Office visits will occur at 30 days, 6, 12, and 24 months post-index procedure.

The BIOPACT RCT tiral investigates the efficacy and safety of stenosis, restenosis or occlusions in the femoropopliteal artery of patients presenting a rutherford classification 2,3 or 4 with a Passeo-18 Lux drug-coated balloon of Biotronik. The Paclitaxel eluting balloons are designed for percutaneous transluminal angioplasties in which the balloon will dilate the artery upon inflation and deliver the paclitaxel locally. An expected total of 151 patients will be treated with the Passeo-18 Lux and compared to a control group of another 151 patients that will be treated with the IN.PACT Admiral drug-coated balloon of Medtronic. Assignment to the treatment groups will be at random. The study will be conducted in two phases. A first pilot study phase of 120 patients distributed evenly over both treatment groups and a second phase to formally test the non-inferiority hypothesis. The balloon is coated with Paclitaxel intended to avoid cellular proliferation. The drug is released by means of rapid inflation as to release a high dose in a short amount of time. Patients will be invited for a follow-up visit at 1, 6 and 12 months post-procedure. The primary efficacy endpoints are defined as follows. Freedom from clinically-driven target lesion revascularization at 12 months. Freedom from device- and procedure-related death through 30 days post-index procedure, major target limb amputation through 12 months post-procedure and clinically-driven target vessel revascularization through 12 months post-index procedure. The secondary endpoints are defined as acute device success, acute procedural success , freedom from all cause of death, major target limb amputation and clinically driven target vessel revascularisation through 30 days post-procedure, sustained clinical improvement, no major adverse events through 6 and 12 months post-procedure, primary patency, target lesion revascularisation, target vessel revascularisation, binary restenosis, major target limb amputation, thrombosis at target lesion, change of walking impairment questionnaire score from baseline, change in target limb rutherford classification or ABI.

To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.

The BeGraft Plus PMCF Trial investigates the efficacy of the BeGraft Peripheral Plus Stent Graft System in the treatment of iliac stenotic or occlusive lesions (TASC A, B, C and D). An expected total of 20 patients with TASC A and B lesions and an expected total of 50 patients with TASC C and D lesions will be treated. The lesion is located within the native Iliac arteries. Prior to stenting with the BeGraft Peripheral Plus Stent Graft System, pre-dilatation can be performed according to the physician's discretion. Also post-dilatation can be performed according to the physician's discretion. Patients will be invited for a follow-up visit at 1, 6, 12, 24 and 36- month post-procedure. The primary efficacy endpoint of the study is the primary patency at 12 months. The primary safety endpoint is the freedom of periprocedural Serious Adverse Events (SAEs). Secondary endpoint include primary patency rate at 1, 6, 24, and 36-month, stent graft occlusion rate at pre-discharge,1, 6, 24, and 36 month follow-up, anke-brachial index (ABI) at 1, 6, 12, 24 and 36-month follow-up, amputation rate at 1, 6, 12, 24 and 36-month follow-up, performance success rate, freedom from target lesion revascularization (TLR), technical success and clinical success at 1, 6, 12, 24 and 36-month follow-up. The extension in the Begraft Plus protocol is being made to evaluate the long-term safety and efficacy of the BeGraft Peripheral Plus Stent Graft.