Clinical trials: Femoropopliteal Disease
Skeletal Muscle Ischemia, Severe Lower Limb Ischemia
Protective Effects of L-arginine During Reperfusion by Femoropopliteal Bypass for Lower Limb Ischemic Syndrome in Humans
The symptoms and severity of arterial disease is secondary to perfusion deficit. The specific alteration of the mitochondrial function of ischemic skeletal muscle plays an important role, and therapeutic enhancing mitochondrial…
- Conditions
- Skeletal Muscle Ischemia, Severe Lower Limb Ischemia, Mitochondrial Dysfunction
- Trial name
- NCT02117206
- Testing
- L-arginine (L-arginine Veyron), Nacl
- Where
- France
- Volunteers
- 60 people
- Sponsor
- University Hospital, Strasbourg, France
Peripheral Arterial Disease, Dissection Arterial
Arterial Dissections After Angioplasty by Long vs Short Time of Balloon Inflation: the Randomized Controlled Trial.
Background. Arterial dissections represent the typical complication of the percutaneous transluminal angioplasty for femoropopliteal disease and have negative impact upon the outcomes of the treatment. Objective.
- Trial name
- LOVES (NCT04442802)
- Testing
- Percutaneous transluminal angioplasty
- Where
- Moldova
- Volunteers
- 100 people
- Sponsor
- Dumitru Casian
PTA (Percutaneous Transluminal Angioplasty ), Femoropopliteal Artery Disease
Clinical Outcomes of GENOSS PCB for Femoropopliteal Artery Disease
The GENOSS PCB study aims to evaluate the safety and efficacy of a Paclitaxel-coated PTA Balloon Catheter(GENOSS® PCB) in patients with the femoropopliteal artery disease.
- Trial name
- GENOSS PCB (NCT07399080)
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Genoss Co., Ltd.
Femoropopliteal Disease
IntravasCular Imaging-Guided Versus AngiogRaphy-GUided Drug-Eluting Stent Implantation for Fermoropopliteal Artery Disease
Objectives: 1) To evaluate the feasibility of using intravascular ultrasound to assess lesion morphology, select an appropriate stent size and landing zone 2) To compare the primary patency rates after intra vascular…
- Trial name
- ICARUS (NCT05805280)
- Testing
- intravascular ultrasound-guided group, angiography-guided group
- Where
- 8 sites in South Korea
- Volunteers
- 100 people
- Sponsor
- Asan Medical Center
Peripheral Arterial Disease
Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions
This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions.
- Trial name
- NCT05894863
- Testing
- Smart flex stent
- Where
- China
- Volunteers
- 120 people
- Sponsor
- RenJi Hospital
Peripheral Arterial Disease
Investigational Study of SWM-831 to Treat Moderate and Severely Calcified Femoropopliteal Arteries
Disrupt PAD Japan is a prospective, multi-center, single-arm study of SWM-831 to treat moderate and severely calcified femoropopliteal arteries, prior to DCB or stenting.
- Trial name
- NCT06938854
- Testing
- Peripheral Intravascular Lithotripsy (IVL)
- Where
- 10 sites in Japan
- Volunteers
- 81 people
- Sponsor
- Shockwave Medical, Inc.
Peripheral Artery Disease
Evaluating the Safety and Efficacy of the G-stream® Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
A multicenter, randomized, controlled, superiority clinical trial to evaluate the efficacy and safety of drug-eluting peripheral arterial stent system（G-stream） in the treatment of femoropopliteal artery stenosis or occlusion.
- Trial name
- G-streamPAD (NCT05780359)
- Testing
- Drug eluting stent, drug coating balloon
- Where
- China
- Volunteers
- 280 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Peripheral Artery Disease
Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries
To compare the efficacy and safety of stent angioplasty with Orchid 035 Drug Coated Dilatation (DCB) and Plain Old Balloon Angioplasty (POBA) for post-dilatation for long (>10cm) femoropopliteal chronic total occlusion.
- Trial name
- SFPA (NCT03791970)
- Testing
- Orchid 035 DCB Catheter, POBA Catheter
- Where
- 3 sites in China
- Volunteers
- 180 people
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Atherosclerosis, Lower Extremity Ischemia
Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusive Disease
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.
- Conditions
- Atherosclerosis, Lower Extremity Ischemia, Claudication, Rest Pain
- Trial name
- NCT00693823
- Testing
- Femoral-popliteal Bypass, Angioplasty and stent placement with Viabahn covered stent-graft(W.L. Gore & Associates, Flagstff, Arizona) of superficial femoral artery
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- Texas Vascular Associates
Peripheral Arterial Disease, Femoropopliteal Lesions
BATTLE Trial: Bare Metal Stent Versus Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate Length Femoropopliteal Lesions
Over the past years, endovascular interventions have become an important part of treatment in patients with peripheral arterial disease.1 Indication for endovascular repair of femoropopliteal lesions has been considerably…
- Trial name
- BATTLE (NCT02004951)
- Testing
- Misago RX, Zilver PTX
- Where
- 11 sites in France
- Volunteers
- 186 people
- Sponsor
- Nantes University Hospital
Peripheral Arterial Disease
Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System
To demonstrate that the BioMimics 3D Stent System meets the performance goals defined by VIVA Physicians, Inc. for the safety and effectiveness of Nitinol stents used in the treatment of symptomatic disease of the femoropopliteal…
- Trial name
- MIMICS-2 (NCT02400905)
- Testing
- BioMimics 3D Vascular Stent System
- Where
- 43 sites in United States, Germany and 1 more
- Volunteers
- 271 people
- Sponsor
- Veryan Medical Ltd.
Chronic Limb Threatening Ischemia
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Peripheral arterial disease (PAD) is a widespread pathology affecting over 200 million adults globally and is primarily caused by atherosclerosis.
- Trial name
- LASER-S (NCT07858539)
- Testing
- Laser atherectomy followed by Sirolimus-eluting balloon angioplasty of femoropopliteal or infrapopliteal or both arterial stenosis or occlusions
- Where
- Greece
- Volunteers
- 55 people
- Sponsor
- Attikon Hospital
Peripheral Vascular Disease, Intermittent Claudication
DURABILITY-200: EverFlex 200mm Long Nitinol Stents in TASC C&D Femoropopliteal Lesions
The objective of this clinical investigation is to evaluate the long-term (up to 12 months) outcome of the 200 mm long self-expanding nitinol EverFlex (ev3) stent in long femoropopliteal lesions (TASC C \& D) Is is the first time…
- Conditions
- Peripheral Vascular Disease, Intermittent Claudication, Critical Limb Ischemia
- Trial name
- NCT00637741
- Testing
- Everflex 200
- Where
- 2 sites in Belgium
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Flanders Medical Research Program
Peripheral Artery Disease
Sirolimus- vs. Paclitaxel-Drug Coated Ballons in Patients With Peripheral Artery Disease
This study is a prospective, interventional, multi-center 1:1 randomized non-inferiority trial. The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with…
- Trial name
- SIRONA (NCT04475783)
- Testing
- Percutaneous Transluminal Angioplasty (PTA)
- Where
- 22 sites in Austria, Germany
- Volunteers
- 478 people
- Sponsor
- Jena University Hospital
Popliteal Artery Disease, Superficial Femoral Artery Disease
A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.
Percutaneous Transluminal Angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries.
- Trial name
- MAGICAL SFA (NCT07359807)
- Testing
- Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter, Paclitaxel drug-coated balloon angioplasty
- Volunteers
- 478 people
- Sponsor
- Concept Medical Inc.
Peripheral Arterial Disease
Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization
This is a prospective, multi-center, pilot feasibility study to document the effects of adventitial delivery of temsirolimus or temsirolimus with dexamethasone sodium phosphate injection, USP, after revascularization of…
- Trial name
- TAP-DANCE (NCT03942601)
- Testing
- Temsirolimus, Temsirolimus and dexamethasone sodium phosphate
- Where
- 11 sites in United States
- Volunteers
- 10 people
- Sponsor
- Mercator MedSystems, Inc.
Peripheral Vascular Disease, Femoral Occlusive Disease
New Anastomotic Device for End to End Vascular Anastomosis in the Treatment of Peripheral Vascular Disease
The medical device "Vascular Join" represents a new anastomotic technology that should reduce the inter-surgeons variability in anastomosis construction and increase the performances in terms of results.
- Conditions
- Peripheral Vascular Disease, Femoral Occlusive Disease, Femoropopliteal Occlusive Disease, Aortoiliac Atherosclerosis
- Trial name
- VJ (NCT01514916)
- Testing
- mechanical anastomosis without suture
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- Ab Medica Spa
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
SELUTION4SFA Trial
This study aims to demonstrate the safety and efficacy of the SELUTION SLR™ 018 DEB compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA)…
- Trial name
- NCT05132361
- Testing
- SELUTION SLR™ 018 DEB, Plain (Uncoated) Balloon Angioplasty (PTA)
- Where
- 34 sites in United States, Austria and 2 more
- Volunteers
- 300 people
- Sponsor
- M.A. Med Alliance S.A.
Peripheral Vascular Diseases, Intermittent Claudication
PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents
The investigators evaluated whether primary implantation of a self-expanding nitinol stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty with optional secondary…
- Conditions
- Peripheral Vascular Diseases, Intermittent Claudication, Angioplasty
- Trial name
- NCT00715416
- Testing
- Nitinol stent, Nitinol Stent Placement
- Where
- Austria
- Volunteers
- 76 people
- Sponsor
- Vienna General Hospital
Peripheral Arterial Disease, Iliac Artery Disease
Endovascular Treatment of Peripheral Artery Disease (PAD)
The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635 or Qualimed Pontos-pp) or balloon angioplasty (Cardionovum Legflow or Optimed…
- Conditions
- Peripheral Arterial Disease, Iliac Artery Disease, Femoropopliteal Occlusive Disease, Below-the-knee Obstruction
- Trial name
- NCT03414515
- Testing
- Endovascular intervention
- Where
- Belgium
- Volunteers
- 200 people
- Sponsor
- Duomed