Clinical trials: Femoropopliteal Occlusive Disease, active
Peripheral Arterial Disease
Post-Market Study of ZENFLEX Pro Stent for Femoropopliteal Artery Lesions
This is a prospective, multi-center, single-arm post-market study evaluating the safety and effectiveness of the ZENFLEX Pro™ Drug-eluting Stent in treating femoropopliteal artery stenosis or occlusion.
- Trial name
- NCT07049120
- Testing
- ZENFLEX Pro™ Peripheral Drug-eluting Stent System
- Where
- Poland
- Volunteers
- 153 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Femoropopliteal In-Stent Restenosis (ISR)
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal in-stent restenosis (ISR) remains an important cause of recurrent symptoms and repeat revascularization after lower-extremity endovascular treatment.
- Trial name
- NCT07277218
- Testing
- Drug-Coated Balloon-First Strategy, Eluvia Drug-Eluting Stent-First Strategy
- Where
- 10 sites in China
- Volunteers
- 600 people
- Sponsor
- Chunshui He
Peripheral Arterial Disease
Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions
This study is an investigator-initiated, prospective, single-center, 1:1 randomized pilot study. The trial evaluates the safety and efficacy of intravascular lithotripsy in comparison to standard lesion preparation using standard…
- Trial name
- CRACK-IT (NCT06112171)
- Testing
- Intravascular lithotripsy, Standard lesion preparation
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- University of Leipzig
Peripheral Arterial Disease
Post-market Registry Study on the Safety and Efficacy of ZENFLEX Pro™ Peripheral Drug-eluting Stent System for Femoropopliteal Artery Lesions
This is a prospective, multi-center, single-arm post-market study evaluating the safety and effectiveness of the ZENFLEX Pro™ Drug-eluting Stent in treating femoropopliteal artery stenosis or occlusion.
- Trial name
- NCT07122167
- Testing
- Peripheral Drug-eluting Stent System
- Where
- Poland
- Volunteers
- 153 people
- Sponsor
- MDCECRO LLC
Peripheral Arterial Disease, Symptomatic Femoropopliteal Lesions
The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)
The purpose of this post-market surveillance study will be to evaluate the real-world use of the DETOUR System in treated patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total…
- Trial name
- PTAB1 (NCT06315023)
- Testing
- DETOUR System
- Where
- 10 sites in United States
- Volunteers
- 450 people
- Sponsor
- Endologix
Peripheral Arterial Disease
A Trial to Evaluate the Safety and Efficacy of the Passeo-18 Lux Drug-coated Balloon of Biotronik in the Treatment of the Femoropopliteal Artery Compared to the Medtronic IN.PACT Admiral Drug-coated Balloon.
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…
- Trial name
- BIOPACT-RCT (NCT03884257)
- Testing
- Passeo-18 Lux treatment group, IN.PACT Admiral treatment group
- Where
- 14 sites in Austria, Belgium and 2 more
- Volunteers
- 302 people
- Sponsor
- KANDO Research
Safety Issues, Efficacy, Self
DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease
This study aims to compare the mid- and long-term outcomes between paclitaxel-coated balloon and primary selective stenting in the treatment of TASC C/D femoropopliteal artery occlusive disease.
- Trial name
- NCT05517291
- Testing
- paclitaxel-coated balloon angioplasty or bare mental stents implantation
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Peking Union Medical College Hospital
Peripheral Artery Disease (PAD)
A Study to Evaluate the Safety and Effectiveness of the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System in Adults With Peripheral Artery Disease (PAD)
The purpose of this clinical study is to learn if the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System is safe and works well to help people with peripheral artery disease (PAD) who have hard, calcium-filled…
- Trial name
- SPARC (NCT07209085)
- Testing
- FastWave Artero™ Peripheral IVL System
- Volunteers
- 110 people
- Sponsor
- FastWave Medical
Peripheral Arterial Occlusive Disease, Femoropopliteal Artery Occlusion
FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
The purpose of this clinical trial is to analyze patency after autologous infrainguinal bypass surgery in patients receiving a venous conduit versus a covered venous conduit.
- Conditions
- Peripheral Arterial Occlusive Disease, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis, Critical Limb-Threatening Ischemia
- Trial name
- Framed IVB (NCT06082466)
- Testing
- FRAMED Infrainguinal Venous Bypass, Conventional Autologous Bypass
- Where
- Austria
- Volunteers
- 110 people
- Sponsor
- Paracelsus Medical University
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 Disease, Peripheral Arterial Disease
EVERO Drug-coated Balloon (DCB) Randomized Trial
The primary objective of the study is to evaluate the long-term safety and effectiveness of the Advance Evero™ 18 Everolimus-coated Percutaneous Transluminal Angioplasty Balloon Catheter (hereafter referred to as the Evero…
- Trial name
- NCT07144150
- Testing
- Evero DCB, Paclitaxel DCB
- Where
- 15 sites in United States
- Volunteers
- 410 people
- Sponsor
- Cook Research Incorporated
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 Artery Disease (PAD), Chronic Limb Threatening Ischemia
Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions
There is a lack of prospective observational studies of shockwave balloons in the treatment of moderate-to-severe calcification of the femoral popliteal artery at the international level.
- Trial name
- SHIELD (NCT06713850)
- Testing
- Shockwave balloons
- Where
- China
- Volunteers
- 130 people
- Sponsor
- Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Peripheral Arterial Disease
The Efficacy of Heparin-boned Viabahn Endoprosthesis and Paclitaxel-coated Balloons for Complex Femoropopliteal Lesions
The purpose of this study is to evaluate the effectiveness of the Viabahn endoprosthesis for treating long femoropopliteal lesions (stenosis ≥ 25cm, occlusion ≥ 15cm) or recurrent in-stent restenosis compared to drug-coated…
- Trial name
- NCT06124755
- Testing
- Viabahn endoprosthesis group, Drug-coated balloon group
- Where
- China
- Volunteers
- 60 people
- Sponsor
- RenJi Hospital
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
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
Peripheral Artery Disease, Femoropopliteal Stenosis
Histological Segmentation of the Superficial Femoral Artery From Microscan to CT Using Artificial Intelligence
The femoropopliteal artery segment (FPAS) is one of the longest arteries in the human body, undergoing torsion, compression, flexion and extension due to lower limb movements.
- Trial name
- CTPred (NCT06260488)
- Testing
- Endovascular surgery
- Where
- France
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University Hospital, Strasbourg, France
PAD - Peripheral Arterial Disease, PAD
Distrupt Stiffness Trial
Typical symptoms of PAD include exercise-induced pain in the legs (known as intermittent claudication), which can significantly limit pain-free walking. In more advanced stages, pain may also occur at rest.
- Trial name
- NCT07130526
- Testing
- Intravascular Lithotripsy (IVL) plus DCB, POBA plus DCB
- Where
- 2 sites in Germany
- Volunteers
- 40 people
- Sponsor
- University Hospital, Essen
Peripheral Arterial Disease
A Real-world Study to Evaluate the Effectiveness of Intravascular Lithotripsy in Moderate to Severe Calcification Lesion of Lower Extremity Femoropopliteal Artery
Vascular calcification is prevalent in patients with Peripheral artery disease (PAD), especially those with combined diabetes or chronic kidney disease.
- Trial name
- STRIKE (NCT06636968)
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shanghai Zhongshan Hospital
Chronic Limb Threatening Ischemia, Chronic Limb-Threatening Ischemia
ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia
ORACLE is a Europe-wide study that will follow 250 people with critical limb-threatening ischemia (CLTI). It aims to see how well orbital atherectomy (OA) works in real-life practice.
- Trial name
- ORACLE (NCT07270562)
- Testing
- Stealth 360™ Peripheral Orbital Atherectomy System from Abbott
- Where
- United Kingdom
- Volunteers
- 250 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe