Clinical trials: Femoropopliteal Occlusive Disease
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, 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
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 Arterial Disease (PAD)
Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses
This randomized multi-center study is intended to compare different coatings on stents for treatment of lesions of the above-the-knee femoropopliteal artery.
- Trial name
- XPEDITE (NCT02936622)
- Testing
- Zilver® Paclitaxel-Eluting Peripheral Stent, Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating, Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating
- Where
- 11 sites in Germany, New Zealand
- Volunteers
- 176 people
- Sponsor
- Cook Group Incorporated
Peripheral Arterial Disease, Peripheral Vascular Disease
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon
To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Disease, Artery Disease, Peripheral, Femoropopliteal Artery Occlusion
- Trial name
- TRANSCEND (NCT03241459)
- Testing
- Surmodics SurVeil DCB, Medtronic IN.PACT Admiral DCB
- Where
- 63 sites in United States, Australia and 7 more
- Volunteers
- 446 people
- Sponsor
- SurModics, Inc.
Peripheral Arterial Disease
Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis
The purpose of this study is to compare balloon angioplasty plus SBCV against balloon angioplasty alone for treatment of stenosis within the femoropopliteal artery.
- Trial name
- SHIELD (NCT02568293)
- Testing
- SBCV, Saline
- Where
- 8 sites in Australia, New Zealand
- Volunteers
- 66 people
- Sponsor
- Symic Vascular
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
REFLOW Study, Investigating the Efficacy of the LEGFLOW DCB in TASC C&D Fempop Lesions
A physician initiated trial investigating the LEGFLOW Paclitaxel-Eluting Peripheral Balloon dilatation catheter for the treatment of femoropopliteal lesions longer than 15cm.
- Trial name
- NCT02580955
- Testing
- LEGFLOW DCB
- Where
- 4 sites in Belgium
- Volunteers
- 120 people
- Sponsor
- Flanders Medical Research Program
Peripheral Artery Disease, Femoropopliteal Artery Stenosis
Data Registry Following Patients Using Supera Stent in the Femoral Arteries
Long-term, observational, prospective, multicenter registry following patients who have been implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in the superficial femoral and/or…
- Conditions
- Peripheral Artery Disease, Femoropopliteal Artery Stenosis, Peripheral Vascular Disease
- Trial name
- STRONG (NCT01154751)
- Testing
- SUPERA Interwoven self-expanding nitinol stent
- Where
- 4 sites in Germany
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Peripheral Arterial Disease
Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.
- Trial name
- EXCITE ISR (NCT01330628)
- Testing
- Turbo Elite Laser and Turbo Tandem Laser Guide Catheters, Balloon angioplasty
- Where
- 34 sites in United States, Puerto Rico
- Volunteers
- 252 people
- Sponsor
- Spectranetics Corporation
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.
Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions, Moderate or Severe Claudication (Rutherford Category 2 or 3)
Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease (K-ELUVIA Registry)
Prospective, multi-center single-arm observational study A total of 100 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included.
- Conditions
- Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions, Moderate or Severe Claudication (Rutherford Category 2 or 3), Critical Limb Ischemia (Rutherford Category 4 or 5)
- Trial name
- NCT03505931
- Testing
- Implantation of Eluvia stent
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Yonsei University
Peripheral Arterial Disease
Edoxaban in Peripheral Arterial Disease
This study is a randomized, open-label, blinded endpoint, parallel-group, active-control, multi-center, proof-of-concept study in subjects with Peripheral Arterial Disease (PAD), designed to assess the safety and potential…
- Trial name
- ePAD (NCT01802775)
- Testing
- edoxaban, Clopidogrel, Aspirin
- Where
- 42 sites in United States, Austria and 5 more
- Volunteers
- 203 people
- Sponsor
- Daiichi Sankyo
Femoropopliteal Disease, Drug Coated Balloon
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
The aim of this clinical trial is to determine whether vessel preparation with a non-compliant scoring balloon before drug-coated balloon (DCB) angioplasty provides superior procedural and clinical outcomes compared with vessel…
- Conditions
- Femoropopliteal Disease, Drug Coated Balloon, Critical Limb-Threatening Ischaemia, Peripheral Arterial Disease
- Trial name
- DASBAD-NC (NCT07764016)
- Testing
- Non-compliant Plain Balloon angioplasty (PBA), Non-compliant Scoring Balloon Angioplasty (SB)
- Volunteers
- 142 people
- Sponsor
- Marc Sirvent