Clinical trials: Femoropopliteal Disease
Peripheral Arterial Disease
Paclitaxel Coated Balloon Catheter for Prevention of Restenosis in Femoropopliteal Arteries
The PACCOCATH FEM study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in prevention of restenosis after femoropopliteal angioplasty.
- Trial name
- PACCOCATH_F (NCT00472472)
- Testing
- paclitaxel coated balloon catheter (device with drug)
- Where
- 2 sites in Germany
- Volunteers
- 87 people
- Sponsor
- University Hospital, Saarland
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
Treatment of Complex Femoropopliteal Artery Lesions Using Drug-coated PTA Balloon
Although DCBs had been widely applicable after registration, there are still lack of clinical data and evidence in the real world condition of Chinese population.
- Trial name
- NCT05616520
- Testing
- drug-coated balloon
- Where
- China
- Volunteers
- 838 people
- Sponsor
- Xuanwu Hospital, Beijing
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.
Peripheral Arterial Diseases
Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease
To assess the safety and effectiveness of adventitial deposition of the Study Drug in reducing inflammation and restenosis in patients with clinical evidence of claudication or critical limb ischemia and an angiographically…
- Trial name
- DANCE (NCT01983449)
- Testing
- Dexamethasone Sodium Phosphate Injection, USP
- Where
- 38 sites in United States
- Volunteers
- 285 people
- Sponsor
- Mercator MedSystems, Inc.
Peripheral Artery Disease
Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease
To compare two different Paclitaxel coated balloons in the treatment of high grade stenotic or occluded lesions in Superficial femoropopliteal artery (SFA )and/or Proximal Popliteal Artery in Peripheral Artery Disease (PAD)…
- Trial name
- NCT02701543
- Testing
- Ranger Drug Eluting Balloon, In Pact Drug Eluting Balloon
- Where
- Germany
- Volunteers
- 414 people
- Sponsor
- University of Leipzig
Thrombosis, Deep Vein, Iliofemoral; Thrombosis
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT
This is a study of a medical procedure that utilizes a commercially available catheter (the Bullfrog® Micro-Infusion Device) to locally deliver a commercially available anti-inflammatory drug (dexamethasone sodium phosphate…
- Trial name
- DEXTERITY-AFP (NCT04862468)
- Testing
- Perivascular dexamethasone
- Where
- 22 sites in United States, Ireland and 1 more
- Volunteers
- 80 people
- Sponsor
- Mercator MedSystems, 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
Restenosis, Peripheral Arterial Disease
Local Delivery of Paclitaxel Via the TAPAS Catheter to Prevent Restenosis From Percutaneous Femoropopliteal Intervention
The purpose of this study is to assess the safety and efficacy of administering intra-arterial paclitaxel in the femoropopliteal arteries via the TAPAS catheter following percutaneous revascularization to prevent restenosis.
- Trial name
- PacTAP (NCT01599078)
- Testing
- Paclitaxel
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Midwest Cardiovascular Research Foundation
Chronic Limb Threatening Ischemia
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Peripheral arterial disease (PAD) is a widespread pathology affecting over 200 million adults globally and is primarily caused by atherosclerosis.
- Trial name
- LASER-S (NCT07858539)
- Testing
- Laser atherectomy followed by Sirolimus-eluting balloon angioplasty of femoropopliteal or infrapopliteal or both arterial stenosis or occlusions
- Where
- Greece
- Volunteers
- 55 people
- Sponsor
- Attikon Hospital
Peripheral Artery Disease, In-stent Restenosis
LDD in Treatment of Femoropopliteal ISR
This study will evaluate the effectiveness and safety of local drug delivery using TAPAS balloon catheter system in the treatment of femoropopliteal in-stent restenosis.
- Trial name
- NCT03521843
- Testing
- balloon dilation only, balloon dilation+local drug delivery
- Where
- China
- Volunteers
- 40 people
- Sponsor
- RenJi Hospital
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
Femoropopliteal Artery Disease
Comparison of the PrimAry Long Versus Short Coverage With Drug-Eluting Stents for Long FemoRopopliteal Artery DiseasE (PARADE II): Investigator-initiated Clinical Study
Prospective, randomized, controlled, multi-center study A total of 220 subjects with long femoropopliteal lesions will be included according to inclusion and exclusion criteria.
- Trial name
- NCT02701881
- Testing
- Long stenting using drug-eluting stent (Zilver PTX), Spot stenting using drug-eluting stent (Zilver PTX)
- Where
- South Korea
- Volunteers
- 220 people
- Sponsor
- Yonsei University
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 Occlusive Disease, Bypass Complication
The SIR-POBA Bypass Trial
The goal of this clinical trial is to compare plain old balloon angioplasty with sirolimus-coated balloon angioplasty in patients with an infrainguinal venous bypass stenosis.
- Conditions
- Peripheral Arterial Occlusive Disease, Bypass Complication, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis
- Trial name
- NCT06056193
- Testing
- Balloon Angioplasty
- Where
- Austria
- Sponsor
- Paracelsus Medical University
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, 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 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
Restenosis, Peripheral Vascular Disease
JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions
Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads to improved overall results compared to balloon angioplasty alone.
- Trial name
- JetStreamISR (NCT01722877)
- Testing
- JetStream Navitus
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- Midwest Cardiovascular Research Foundation
Femoropopliteal Artery Lesions
Ranger™ and Ranger™ SL (OTW) DCB) in China
This clinical study is a prospective, non-randomized, multicenter study to demonstrate the acceptable safety and performance of angioplasty with the Ranger DCB in native femoropopliteal artery lesions.
- Trial name
- NCT02944071
- Testing
- Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter
- Where
- 9 sites in China
- Volunteers
- 123 people
- Sponsor
- Boston Scientific Corporation