Clinical trials: Femoropopliteal Disease
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
First-in-man Study of Titanium-Nitride Coated Woven-nitinol Peripheral Arterial Stent
The GoldenFlow (Lifetech Scientific, Shenzhen, China) is a novel woven-nitinol stent designed to have superior radial strength, flexibility and durability compared to standard nitinol stents for femoropopliteal lesions.
- Trial name
- NCT02499510
- Testing
- GoldenFlow Stent
- Where
- Hong Kong
- Volunteers
- 5 people
- Sponsor
- Chinese University of Hong Kong
Femoral Artery Stenosis, Femoral Artery Occlusion
A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries
To assess the safety and efficacy of the BARD LTX DCB for treatment of stenosis or occlusion of the superficial femoral and popliteal arteries.
- Conditions
- Femoral Artery Stenosis, Femoral Artery Occlusion, Stenosis of Popliteal Arteries, Occlusion of Popliteal Arteries
- Trial name
- NCT02720003
- Testing
- LTX DCB
- Where
- 14 sites in China
- Volunteers
- 148 people
- Sponsor
- C. R. Bard
Peripheral Arterial Disease, Atherosclerosis
Sonodynamic Therapy on Patients With Femoropopliteal PAD and Claudication
The purpose of this trial is to evaluate the safety and efficacy of sonodynamic therapy (SDT) in reducing atherosclerotic plaques inflammation and increasing peak walking time (PWT) among peripheral artery disease (PAD) patients…
- Conditions
- Peripheral Arterial Disease, Atherosclerosis, Cardiovascular Diseases
- Trial name
- NCT03318484
- Testing
- Optimal Medical Care, Sonodynamic therapy
- Sponsor
- First Affiliated Hospital of Harbin Medical University
Peripheral Arterial Disease
DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes
This is a prospective, multi-center, observational registry to document the baseline, 24-hour and 30-day inflammatory response and procedural outcomes out to 12 month follow-up after femoropopliteal angioplasty or…
- Trial name
- NCT02469532
- Testing
- Balloon Angioplasty, Atherectomy System
- Where
- 6 sites in United States
- Volunteers
- 31 people
- Sponsor
- Mercator MedSystems, Inc.
Peripheral Arterial Disease
Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)
Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to…
- Trial name
- NCT02923193
- Testing
- Shockwave Lithoplasty® Peripheral Lithoplasty System, Medtronic IN.PACT (DCB)
- Where
- 54 sites in United States, Austria and 2 more
- Volunteers
- 306 people
- Sponsor
- Shockwave Medical, Inc.
Peripheral Arterial Disease, Restenosis
Local Paclitaxel Delivery to Prevent Restenosis in Peripheral Arterial Disease
The purpose of this study is to determine if the addition of a catheter-based local delivery of paclitaxel into the peripheral arterial vessels in patients with peripheral arterial disease (PAD) and subsequent restenosis of the…
- Trial name
- ResTAP (NCT03858764)
- Sponsor
- Jane Phillips Medical Center
Peripheral Arterial Disease
Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions
The study is a prospective, multicenter, randomized pilot study to evaluate the clinical outcome of the plaque atherectomy system followed by the UltrafreeTM drug coated balloon catheter versus the drug coated balloon in patients…
- Trial name
- NCT05868564
- Testing
- Atherectomy+Drug-coated balloon, Drug-coated balloon
- Where
- China
- Volunteers
- 100 people
- Sponsor
- RenJi Hospital
Femoropopliteal Occlusive Disease
Accessing Peripheral Occluded LesiOns II (APOLO-II)
The current study is a prospective, single-arm, non-randomized, multi-center study to evaluate the outcome of the ENABLER-P Catheter System for crossing chronic total occlusions during endovascular intervention for…
- Trial name
- APOLO-II (NCT01884701)
- Testing
- ENABLER-P Catheter System
- Sponsor
- EndoCross Ltd.
Peripheral Arterial Disease, Subarachnoid Block
Effect of Subarachnoid Block and Femoropopliteal Block to Limb Perfusion in PAD Patients
This pilot study investigates the effects of femoropopliteal and subarachnoid nerve blocks on tissue oxygen saturation (StO2) in patients with Peripheral Arterial Disease (PAD) during lower limb surgeries.
- Conditions
- Peripheral Arterial Disease, Subarachnoid Block, Femoropopliteal Block, Tissue Oxygen Saturation
- Trial name
- NCT06702202
- Testing
- Mixture of local anesthetics, 0.5% hyperbaric bupivacaine
- Where
- Indonesia
- Volunteers
- 16 people
- Sponsor
- Universitas Indonesia
Peripheral Artery Disease (PAD)
Α Pre CE-Marking Study Using the Rontis Drug Coated Balloon for Treatment of Lesions in Femoropopliteal Arteries
The Rontis Drug Coated - Peripheral Balloon Catheter is intended for PTA procedure on atherosclerotically stenotic or obstructed vessels and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis…
- Trial name
- NCT04821388
- Testing
- Rontis DCB
- Where
- 5 sites in Greece
- Volunteers
- 30 people
- Sponsor
- Rontis Hellas SA
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.
Atherosclerosis, Lower Extremity Ischemia
Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusion
A retrospective review with four year followup on patients that had previously been enrolled in a study to evaluate blockages in the lower legs.
- Conditions
- Atherosclerosis, Lower Extremity Ischemia, Claudication, Rest Pain
- Trial name
- NCT00962897
- Testing
- Femoral-popliteal bypass, Stent-graft placement
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Texas Vascular Associates
Peripheral Vascular Disease (PVD), Peripheral Arterial Disease (PAD)
A Clinical Trial to Evaluate the Efficacy and Safety of a Spot Stent System Used in Femoropopliteal Arteries.
A prospective randomized trial designed to compare the efficacy and safety of spot stent system versus self-expanding peripheral stent system in the endovascular treatment of femoropopliteal arterial stenotic disease.
- Trial name
- NCT05246410
- Testing
- Spot stent system, Self-expanding peripheral stent system
- Where
- 2 sites in China
- Volunteers
- 196 people
- Sponsor
- Acotec Scientific Co., Ltd
Arteriosclerosis Obliterans
Sufficient Treatment of Peripheral Intervention by Cilostazol
Recently, Nanto et al. reported that cilostazol effectively prevented restenosis in a retrospective analysis of 121 femoropopliteal artery lesions in percutaneous transluminal angioplasty (PTA) patients who had undergone PTA.
- Trial name
- STOP-IC (NCT00912756)
- Testing
- cilostazol
- Where
- 13 sites in Japan
- Volunteers
- 200 people
- Sponsor
- Kansai Rosai Hospital
Peripheral Arterial Disease, Peripheral Vascular Diseases
Safety and Feasibility of SurModics SurVeil (TM) Drug Coated Balloon
PREVEIL is a prospective, multi-center, single-arm clinical trial to assess the safety and functionality of the SurModics drug coated balloon (DCB) in the treatment of subjects with symptomatic peripheral artery disease (PAD) due…
- Trial name
- PREVEIL (NCT02648620)
- Testing
- SurVeil Drug Coated Balloon, Angioplasty
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- SurModics, Inc.
Peripheral Artery Disease
Bard LifeStent and Lutonix DCB for Treatment of Long Lesions in Femoropopliteal Arteries
Objective of this study is to evaluate the safety and efficacy of Lutonix 035 Drug Coated Dilatation PTA Catheter with Bard LifeStent Vascular Stent (hereinafter referred to as LifeStent) for treatment of long (10-24 cm) lesions…
- Trial name
- NCT02278991
- Testing
- Lutonix Drug Coated Balloon
- Where
- 12 sites in Germany, Greece and 1 more
- Volunteers
- 149 people
- Sponsor
- C. R. Bard
Peripheral Arterial Disease
TurboPower + DCB Treatment of Femoropopliteal De Novo/ Restenotic and In-Stent Restenosis Lesions
A retrospective study to evaluate Turbo Power laser atherectomy + drug coated balloon (DCB) angioplasty for the treatment of femoropopliteal de novo/restenotic lesions and in-stent restenosis (ISR).
- Trial name
- NCT03306199
- Testing
- Laser Atherectomy
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Spectranetics Corporation
Peripheral Arterial Disease, Atherosclerosis
Efficacy of Subintimal vs Intraluminal Approach for Atherosclerotic Chronic Occlusive Femoropopliteal Arterial Disease
There are two ways of approaching atherosclerotic chronic occlusive femoro-popliteal arterial lesion with guide wire. One is the intraluminal approach of passing guide wire through the atheroma, the other is the subintimal…
- Trial name
- SCENARIO-FP (NCT02544555)
- Testing
- Intentional intraluminal approach, Intentional subintimal approach
- Where
- 3 sites in South Korea
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Korea University Guro Hospital
Peripheral Artery Disease, Femoropopliteal Artery Occlusion
LEVANT 2 Safety Registry
The primary objective of the LEVANT 2 Extended Follow-up Post-Approval Study (PAS 1) is to evaluate the long-term performance of the Lutonix Drug Coated Balloon (DCB) versus Percutaneous Transluminal Balloon Angioplasty (PTA) in…
- Conditions
- Peripheral Artery Disease, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis
- Trial name
- NCT01790243
- Testing
- Lutonix Drug Coated Balloon, Standard PTA Balloon
- Where
- 8 sites in United States
- Volunteers
- 1,189 people
- Sponsor
- C. R. Bard