Clinical trials: Femoropopliteal Artery Occlusion
Peripheral Arterial Disease
Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion
This study will assess the safety and efficacy of Chocolate balloons as a combination with drug-coated balloons in the treatment of popliteal artery lesions in lower limb atherosclerotic occlusive disease and will compare them…
- Trial name
- NCT05894460
- Testing
- Chocolate balloon
- Where
- China
- Volunteers
- 254 people
- Sponsor
- Xuanwu Hospital, Beijing
Peripheral Arterial Disease
Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access
The primary objective of this clinical investigation was to evaluate acute safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System, when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon…
- Trial name
- RADIANCY (NCT05399680)
- Testing
- S.M.A.R.T. RADIANZ™ Vascular Stent System, BRITE TIP RADIANZ™ Guiding Sheath, SABERX RADIANZ™ PTA Balloon Catheter
- Where
- 12 sites in Austria, Belgium and 4 more
- Volunteers
- 151 people
- Sponsor
- Cordis US Corp.
Peripheral Arterial Disease
DETOUR I Clinical Study for Percutaneous Femoropopliteal Bypass
To assess the safety and performance of the PQ Bypass System to access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.
- Trial name
- DETOUR1 (NCT02471638)
- Testing
- PQ Bypass System for Femoropopliteal Bypass
- Where
- 8 sites in Chile, Germany and 4 more
- Volunteers
- 78 people
- Sponsor
- Endologix
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
Shockwave IVL + DES
The objective of this clinical investigation is to evaluate, in a controlled setting, the 12 months safety and efficacy of the combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device, for…
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Calcifications Vascular
- Trial name
- Shockwave DES (NCT05291247)
- Testing
- Peripheral lithotripsy system (Shockwave Medical)
- Where
- 6 sites in Germany
- Volunteers
- 50 people
- Sponsor
- Marc Bosiers, MD
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)
Femoropopliteal Artery Occlusion
Outcome of Endovascular Therapies in Chronic Femoropopliteal Occlusive Disease With Severe Calcification
This study is a prospective, multicenter, real world, observational study, which aims at evaluating the safety, efficacy and economic cost of endovascular treatments for endovascular therapies in chronic femoropopliteal occlusive…
- Trial name
- NCT04716361
- Where
- China
- Volunteers
- 600 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Peripheral Arterial Disease
Belgian Trial Evaluating the ClearLumen II Peripheral Thrombectomy System Recanalization of (sub)acute Thrombotic Femoropopliteal Occlusions
The BELTHROM trial investigates the efficacy and safety of the ClearLumen II Peripheral Thrombectomy System recanalization of acute and subacute thrombotic femoropopliteal occlusions (Acute Limb Ischemia (ALI); Rutherford I, IIa…
- Trial name
- BELTHROM (NCT03368144)
- Testing
- ClearLumen II Peripheral Thrombectomy System
- Where
- 3 sites in Belgium
- Volunteers
- 25 people
- Sponsor
- ID3 Medical
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
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 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
Drug-coated Balloon, Femoropopliteal Artery Occlusion
A Study of Endovascular Treatment of Femoropopliteal Arterial Occlusive Lesion With Drug-Coated Balloon
There have been a number of randomized controlled studies (RCT) showing the efficacy of the endovascular treatment with drug-coated balloons (DCB) in the femoropopliteal artery lesions.
- Conditions
- Drug-coated Balloon, Femoropopliteal Artery Occlusion, Angioplasty
- Trial name
- PROMISING (NCT04826705)
- Testing
- Drug-coated Balloon
- Where
- 9 sites in China
- Volunteers
- 2,000 people
- Sponsor
- Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
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 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 Disease
PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass
To assess the safety of performing a percutaneous fem-pop bypass using the PQ Bypass Guidewire Delivery System and commercially available stent grafts.
- Trial name
- PQB4FP1 (NCT01930071)
- Testing
- PQ Bypass Guide Wire Delivery System
- Where
- New Zealand
- Volunteers
- 4 people
- Sponsor
- Endologix
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, 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 Artery Disease
Korean Post-market Registry Assessing the Clinical Use and Safety of the Lutonix DCB in Femoropopliteal Arteries
The purpose of the registry is to assess the clinical use and safety of the LUTONIX Drug Coated Balloon Catheter in a heterogeneous patient population in real world clinical practice.
- Trial name
- NCT02717104
- Where
- 16 sites in South Korea
- Volunteers
- 249 people
- Sponsor
- C. R. Bard
Femoral Artery Occlusion, Femoral Arterial Stenosis
Lutonix® DCB for Treatment of Long Lesions in Femoropopliteal Arteries
To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA
- Trial name
- NCT02013271
- Testing
- Lutonix Paclitaxel Drug Coated Balloon (DCB)
- Where
- 14 sites in Austria, Belgium and 3 more
- Volunteers
- 125 people
- Sponsor
- C. R. Bard
Peripheral Arterial Disease, Femoropopliteal Stenosis
PMCF Study for Peripheral Arteries Above the Knee (ATK)
The rationale of this study is to confirm and support the clinical safety and performance of the products in a real-word population of 350 patients who underwent an endovascular intervention within standard-of-care (SOC) of the…
- Conditions
- Peripheral Arterial Disease, Femoropopliteal Stenosis, Angiopathy, Peripheral
- Trial name
- NCT05312580
- Where
- 9 sites in Austria, France and 1 more
- Volunteers
- 387 people
- Sponsor
- Cordis US Corp.
Peripheral Artery Disease, Claudication
Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries
The primary objective of this study is to prove the superior performance of the Ranger™ paclitaxel-coated PTA balloon catheter for angioplasty for femoropopliteal artery lesions when compared to non-coated balloons at six months…
- Conditions
- Peripheral Artery Disease, Claudication, Atherosclerosis, Arteriosclerosis
- Trial name
- RANGER-SFA (NCT02013193)
- Testing
- Ranger DCB, uncoated PTA balloon
- Where
- 11 sites in Austria, France and 1 more
- Volunteers
- 105 people
- Sponsor
- Hemoteq AG