Clinical trials: Femoropopliteal Disease
Peripheral Arterial Disease
BIOLUX P-III SPAIN All-Comers Registry
The purpose of the BIOLUX P-III Spain registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Balloon in the treatment of long atherosclerotic femoropoliteal artery lesions in daily…
- Trial name
- NCT03052296
- Testing
- Passeo-18 Lux DCB
- Where
- 5 sites in Spain
- Volunteers
- 44 people
- Sponsor
- Biotronik AG
Superficial Femoral Artery Stenosis, Iliac Artery Stenosis
Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease
The purpose of this study is to evaluate long-term safety and performance per the intended use of the S.M.A.R.T.™ Nitinol Stent System (SMART 120/150), S.M.A.R.T.™ CONTROL™ Nitinol Stent System (SMART CONTROL) and S.M.A.R.T.™…
- Conditions
- Superficial Femoral Artery Stenosis, Iliac Artery Stenosis, Popliteal Artery Stenosis
- Trial name
- REAL-SMART (NCT07338890)
- Testing
- S.M.A.R.T.™ Nitinol Stent System (SMART 120/150), S.M.A.R.T.™ CONTROL ™ Nitinol Stent System, S.M.A.R.T.™ Flex Vascular Stent System
- Where
- Spain
- Volunteers
- 240 people
- Sponsor
- Cordis US Corp.
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 Artery Disease, Peripheral Vascular Disease
Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System
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.
- Conditions
- Peripheral Artery Disease, Peripheral Vascular Disease, Vascular Disease, Cardiovascular Diseases
- Trial name
- OPEN (NCT01355406)
- Testing
- FlexStent® Femoropopliteal Self Expanding Stent System
- Where
- 38 sites in United States, Belgium
- Volunteers
- 257 people
- Sponsor
- Cordis US Corp.
Ischemia
Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty
The use of drug coated balloon (DCB) in patients with critical limb ischemia (CLI) and tissue loss has recently raised some concerns after the IN.PACT deep trial using paclitaxel coated balloon angioplasty in the tibial arteries…
- Trial name
- NCT02758847
- Testing
- Angiogram, Medtronic DCB (paclitaxel)/stent, Angiogram, Bard DCB (paclitaxel)/stent
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Rabih A. Chaer
Peripheral Vascular Diseases
Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
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…
- Trial name
- Zilver PTX (NCT00120406)
- Testing
- Zilver® PTX™ Drug Eluting Vascular Stent, Angioplasty
- Where
- 52 sites in United States, Germany and 1 more
- Volunteers
- 474 people
- Sponsor
- Cook Group Incorporated
Atherosclerosis, Arteriosclerosis
BIOLUX P-I First in Man Study
A prospective, multi-centre, randomized controlled, First in Man study to assess the safety and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs.
- Conditions
- Atherosclerosis, Arteriosclerosis, Vascular Disease, Peripheral Artery Disease
- Trial name
- NCT01221610
- Testing
- Passeo-18 Lux DRB, Standard PTA (POBA)
- Where
- 5 sites in Austria, Germany
- Volunteers
- 60 people
- Sponsor
- Biotronik AG
Peripheral Vascular Disease
SAMBA EU Femoropopliteal Trial
The primary objective of this study is to evaluate the safety and performance of the SAMBA Stent and Delivery System in the treatment of femoropopliteal lesions.
- Trial name
- NCT01139177
- Testing
- Stenting of atherosclerotic lesion(s)
- Where
- 2 sites in Germany
- Volunteers
- 39 people
- Sponsor
- NovoStent Corporation
Cardiovascular Diseases
MRI-Guided Balloon Angioplasty to Treat Blood Flow Blockage in the Legs
This study will examine the use of magnetic resonance imaging (MRI) instead of x-rays to guide angioplasty in patients who require these treatments to treat blockages in leg arteries.
- Trial name
- NCT00094783
- Testing
- MRI
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Peripheral Arterial Disease
Clinical Trial Investigating the Combination Therapy With Luminor DCB and iVolution Stent in TASC C and D Femoropopliteal Lesions
The 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.
- Trial name
- TINTIN (NCT03347383)
- Testing
- Combination therapy DCB + stent
- Where
- 9 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- ID3 Medical
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
Femoropopliteal Artery Occlusion, Atherosclerosis Obliterans
Lesion Preparation in Femoropopliteal Artery Occlusion Disease
Peripheral arterial disease (PAD) carries a significant global health burden, and can limit functional capacity and quality of life.
- Conditions
- Femoropopliteal Artery Occlusion, Atherosclerosis Obliterans, Lesion; Vascular, In-stent Restenosis
- Trial name
- CIVILIAN (NCT05473884)
- Testing
- lesion preparation devices, conventional balloon
- Where
- China
- Volunteers
- 800 people
- Sponsor
- Shanghai Pudong Hospital
Peripheral Arterial Disease, Intermittent Claudication
Systematic Review and Meta-Analysis on DCB vs. POBA in De-novo Femoropopliteal Disease
Restenosis is still an issue after endovascular revascularization for femoropopliteal occlusive disease. One approach to reduce the rates of restenosis and reintervention is local application of Paclitaxel with drug-coated…
- Trial name
- DOND (NCT02927574)
- Testing
- DCB, POBA
- Volunteers
- 1,400 people
- Sponsor
- Jena University Hospital
Peripheral Arterial Disease (PAD)
Zilver PTX Post-Market Study in Japan
Japanese post market clinical study of the Zilver PTX device.
- Trial name
- NCT02254837
- Testing
- Zilver PTX Drug-Eluting Stent
- Volunteers
- 909 people
- Sponsor
- Cook Group Incorporated
Peripheral Artery Disease, Femoropoliteal Stenosis/Occlusion
Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.
Observational registry including patients with peripheral artery disease due to femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).
- Conditions
- Peripheral Artery Disease, Femoropoliteal Stenosis/Occlusion, Cutting-balloon, Drug-coated-balloon
- Trial name
- DEBTRAK (NCT02198105)
- Testing
- Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTA
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Caritasklinik St. Theresia
Peripheral Arterial Disease
Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization
The purpose of this study is to test if dexamethasone, an anti-inflammatory medication approved by the US Food and Drug Administration (FDA), can be injected safely into the tissue around the blood vessel wall at the time of an…
- Trial name
- DANCE (NCT01507558)
- Testing
- Administration of dexamethasone to SFA/popliteal adventitia
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- University of California, San Francisco
Peripheral Arterial Disease, Arterial Occlusive Diseases
Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery
The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.
- Conditions
- Peripheral Arterial Disease, Arterial Occlusive Diseases, Atherosclerosis, Arteriosclerosis
- Trial name
- PAVENST (NCT02212470)
- Testing
- Drug Eluting Balloon Angioplasty, Nitinol stenting
- Where
- Brazil
- Volunteers
- 85 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
Peripheral Vascular Disease
Physician-Initiated Trial Investigating the Efficacy of Endovascular Treatment of Femoropopliteal Arterial Stenotic Disease With the Biotronik Passeo-18 Lux Drug Releasing Balloon and the Biotronik Pulsar-18 Stent (Comparing With 4EVER Trial Results)
The objective of this clinical investigation is to evaluate the short- and long-term (up to 24 months) outcome of treatment by means of dilation with the Passeo-18 Lux drug releasing balloon and by Pulsar-18 stent implantation in…
- Trial name
- BIOLUX 4EVER (NCT02211664)
- Testing
- Passeo-18 balloon, Passeo-18 Lux drug releasing balloon, Pulsar-18 stent
- Where
- 5 sites in Belgium
- Volunteers
- 120 people
- Sponsor
- Flanders Medical Research Program
PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease
One-Year Results of GENOSS PCB Real-World Study in Femoropopliteal Artery Disease
The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB by enrolling and tracking patients who underwent percutaneous transluminal angioplasty using GENOSS PCB in patients with femoropopliteal…
- Trial name
- NCT07431437
- Where
- South Korea
- Volunteers
- 300 people
- Sponsor
- Genoss Co., Ltd.
Intermittent Claudication, Arterial Occlusive Diseases
Dacron vs Dardik for Fem-Pop Bypass
Clinical trial for the comparison of long-term patency of heparin-bonded Dacron and human umbilical vein vascular prostheses in above-knee femoro-popliteal bypass surgery.
- Conditions
- Intermittent Claudication, Arterial Occlusive Diseases, Atheroslerosis
- Trial name
- DaDa (NCT00523263)
- Testing
- heparin-bonded and collagen coated polyster, Human umbilical vein femoro-popliteal bypass
- Where
- Netherlands
- Sponsor
- Radboud University Medical Center