A Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal...
Peripheral Arterial DiseaseCritical Limb IschemiaThis is a non-randomized, prospective, single center pilot study designed to evaluate the safety of the Temporary Spur Stent System to treat patients with infrapopliteal arterial disease, when used in conjunction with a commercially available limus-base drug coated balloon.
Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon
Peripheral Arterial DiseaseCritical Lower Limb IschemiaTo evaluate the safety and performance of the Sundance™ DCB in subjects with occlusive disease of the infrapopliteal arteries.
MOTIV Bioresorbable Scaffold in BTK Artery Disease
Peripheral Arterial DiseaseCritical Limb IschemiaThe objective of this clinical evaluation is to evaluate the immediate and long-term (up to 36 months) outcome of the MOTIV™ Bioresorbable Scaffold (Reva Medical) in a controlled prospective investigation for the treatment of patients with rest pain or minor tissue loss (CLI) due to the presence of lesions of max 100mm in length at the level of the below-the-knee arteries.
A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral...
Diabetes MellitusType 21 moreThis study is done to see if semaglutide has an effect on walking ability compared with placebo (dummy medicine) in people with peripheral arterial disease (PAD) and type 2 diabetes. Participants will either get semaglutide or placebo ("dummy") medicine - which treatment participants get is decided by chance. Semaglutide is a medicine for type 2 diabetes that can be prescribed by doctors in some countries. Participants will get the study medicine (semaglutide or placebo) in a pre-filled pen for injection. Participants must inject it once a week into the stomach area, thigh, or upper arm, at any time of the day. The study will last for about 59 weeks. Participants will have 8 clinic visits and 1 phone call with the study doctor. At some clinic visits, participants will have blood tests. At some visits participants will also do a treadmill test to measure how far they can walk. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Safety Study of MultiGeneAngio in Patients With Peripheral Arterial Disease (PAD)
PADClaudicationThe purpose of this study is to evaluate the safety and activity of increasing doses of MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential treatment for patients with peripheral arterial disease.
BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral...
Peripheral Arterial DiseaseProspective, multi-center 1:1 randomized trial to compare efficacy and safety of a stent-avoiding (using drug coated balloons) versus a stent-preferred (using drug eluting or interwoven stents) approach for treatment of complex femoropopliteal lesions TASC II (TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease) Type B-D (stenosis >10cm, occlusions >5cm).
Efficacy of Rotational Atherectomy System Associated With Drug Coated Balloon Angioplasty in Limb...
Peripheral Vascular DiseasesLower extremity peripheral artery disease (PAD) is a major health problem leading to significant morbidity and even mortality. Patients with superficial femoral artery stenosis make up an important proportion of patients with PAD, and since this type of involvement was reported to be most commonly associated with intermittent claudication, this patient population has been subject to intensive research on methods to prevent disease progression and further complications. Endovascular treatment has become the first-line treatment for low-complexity femoropopliteal (FP) lesions classified as TASC (Trans Atlantic Inter-Societal Consensus) A and B. Conversely, in case of more extensive lesions (TASC C), this treatment is still under debate because of a primary permeability that is difficult to maintain over time. Recently, studies have shown the interest of drug eluting technologies in the treatment of TASC A & B femoral-popliteal lesions, by significantly improving patency rates compared to uncoated balloons or stents. In this context, the endovascular treatment of FP complex lesions (TASC C) continues to develop widely. During endovascular treatment, the quality of the artery preparation has recently been identified as a factor improving outcomes. The dilatation of the artery with an uncoated balloon or POBA (Plain Old Balloon Angioplasty) is the reference method performed before stent placement or drug-coated balloons. However, some new alternatives to prepare the artery have emerged, using no more dilatation but atherectomy (Jetstream™ system). Atherectomy appears to reduce the risk of dissections and bailout stenting and improve the acute procedural results. Its long term outcome, when associated with drug coated balloons (DCB), has recently been demonstrated in the USA to be superior to angioplasty in a single center study JET-SCE. The purpose of this study is to evaluate the efficacy and the feasibility of atherectomy, using the Jetstream™ artery preparation associated to DCB treatment (Ranger™ Paclitaxel-Coated balloon), in symptomatic patients with claudication (Rutherford 2 and 3) and with complex de novo FP arterial lesions (TASC C).
Clinical Trial Investigating the Combination Therapy With Luminor DCB and iVolution Stent in TASC...
Peripheral Arterial DiseaseThe T.I.N.T.I.N. study investigates the safety and efficacy of the combination therapy with the Luminor drug coated balloon (DCB) and the iVolution stent in the treatment of TASC C and D femoropopliteal lesions. An expected total of 100 patients will be treated in the scope of this study. The lesion is located within the native superficial femoral artery and/or the popliteal artery. Prior to dilatation with the Luminor DCB, pre-dilatation with the Oceanus balloon is mandatory. After dilatation with the Luminor DCB, stenting with the iVolution stent need to be performed. 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, 36, 48 and 60 month post-procedure. The primary efficacy endpoint of the study is defined as the freedom from clinically-driven target lesion revascularization (TLR) at 12 months. Secondary endpoints include primary patency rate at 6 and 12 months, freedom from clinically-driven TLR at 6, 24, 36, 48 and 60 months, clinical success at 1, 6, 12, 24, 36, 48 and 60 months and freedom from serious adverse events at pre-discharge, 1, 6, 12, 24, 36, 48 and 60 months follow-up.
Belgian Trial Investigating the LifeStream Stent in Complex TASC C and D Iliac Lesions
Peripheral Arterial DiseaseThe BELSTREAM Trial investigates the efficacy of the LifeStream Peripheral Stent Graft System in the treatment of iliac stenotic or occlusive lesions (TASC C and D). An expected total of 70 patients will be treated. The lesion is located within the native Iliac arteries. Prior to stenting with the LifeStream Peripheral 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 ,36 ,48 and 60-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 ,36 ,48 and 60 month, stent graft occlusion rate at pre-discharge, 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up, anke-brachial index (ABI) at 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up, amputation rate at 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up, technical success and clinical success at 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up.
POWER: Pulse Intravascular Lithotripsy (Pulse IVL) to Open Vessels With Calcific Walls and Enhance...
Peripheral Arterial DiseaseThe POWER-PAD-1 Study is a first-in-human evaluation of the safety and performance of the Pulse Peripheral Intravascular Lithotripsy (IVL) Balloon Catheter to enroll up to twenty (20) subjects.