Clinical trials: Femoral Artery Stenosis
Femoral Artery Stenosis, Iliac Artery Stenosis
Retrospective Study of the Uni-Graft® K DV Patch in the Clinical Routine
Uni-Graft® K DV Patch is marketed in Europe since 1999 for reconstructive interventions of the deep femoral, femoral and iliac artery and was also indicated for carotid interventions until 01/2020.
- Conditions
- Femoral Artery Stenosis, Iliac Artery Stenosis, Carotid Artery Stenosis
- Trial name
- RESTUGPA (NCT05117515)
- Testing
- Vascular reconstruction
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Aesculap AG
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
Femoral Artery Stenosis, Popliteal Artery Stenosis
MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery
The purpose of this trial is to assess the safety and efficacy of MDT-2113 for the interventional treatment of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the proximal popliteal artery…
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- MDT-2113 SFA (NCT01947478)
- Testing
- MDT-2113 Drug-Eluting Balloon, Standard angioplasty balloon
- Where
- Japan
- Volunteers
- 100 people
- Sponsor
- Medtronic Endovascular
Peripheral Arterial Disease, Common Femoral Artery Stenosis
Endovascular Treatment of Primary Common FEmoral Artery atheroSclerotic Disease wiTh IntraVAscular Litothripsy
Prospective, nonrandomized, multicenter, national, multidisciplinary, real-world data collection with the aim to evaluate the short-term safety and efficacy of intravascular lithotripsy in the treatment of steno-obstructive…
- Conditions
- Peripheral Arterial Disease, Common Femoral Artery Stenosis, Common Femoral Artery Occlusion, Critical Limb-Threatening Ischemia
- Trial name
- FESTIVAL (NCT05821829)
- Testing
- Intravascular litothripsy (IVL)
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- University of Pisa
Superficial Femoral Artery Stenosis, Superficial Femoral Artery Occlusion
Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)
This is a prospective randomized controlled trial to compare clinical improvement, cost effectiveness and patency rates between new and improved Nitinol stents and open bypass surgery in the superficial femoral artery disease.
- Conditions
- Superficial Femoral Artery Stenosis, Superficial Femoral Artery Occlusion, Claudication, Rest Pain
- Trial name
- ROBUST (NCT01602159)
- Testing
- Open Bypass Surgery, Angioplasty and Stenting
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- Johns Hopkins University
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
A Study of The Femoral Popliteal Artery Treated With LEGFLOW OTW
To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared with the standard balloon (Admiral Xtreme) for the treatment of stenosis or occlusions in femoral popliteal…
- Trial name
- NCT02965677
- Testing
- Paclitaxel Releasing Peripheral Balloon Dilatation Catheter, Peripheral Balloon Dilatation Catheter
- Where
- 13 sites in China
- Volunteers
- 172 people
- Sponsor
- ZhuHai Cardionovum Medical Device Co., Ltd.
Peripheral Arterial Disease, Iliac Artery Stenosis
SOLARIS Peripheral PMCF Trial
The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term (up to 12 months) safety and efficacy of the Solaris Vascular Stent Graft (Scitech) in clinical settings when used according to…
- Conditions
- Peripheral Arterial Disease, Iliac Artery Stenosis, Common Femoral Artery Stenosis
- Trial name
- NCT04299906
- Testing
- Solaris Vascular Stent Graft
- Where
- 10 sites in Germany, Italy and 1 more
- Volunteers
- 70 people
- Sponsor
- Dr. Sabrina Overhagen
Superficial Femoral Artery Stenosis, Popliteal Artery Stenosis
First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease
This is a prospective, open label, multicenter, single arm, first in human clinical study. Patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be enrolled.
- Trial name
- CHAMPIONSHIP (NCT06410313)
- Testing
- ChampioNIR Ridaforolimus Eluting Peripheral Stent System
- Where
- 7 sites in United States, Australia
- Volunteers
- 30 people
- Sponsor
- Medinol Ltd.
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 Disease, Superficial Femoral Artery Stenosis
LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries
LEGDEB2 is a Global Registry for the Treatment of Superficial Femoral and/or Popliteal or Below-The-Knee or Iliac Artery Lesions Using the Legflow Drug-Eluting Balloon
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Iliac Artery Stenosis, Arterial Occlusive Diseases
- Trial name
- LEGDEB2 (NCT04175197)
- Testing
- Drug Coated Balloon
- Where
- 7 sites in Italy, Mexico
- Volunteers
- 512 people
- Sponsor
- Federico II University
Peripheral Arterial Disease
Paclitaxel Balloon Versus Standard Balloon in In-stent Restenoses of the Superficial Femoral Artery (PACUBA I Trial)
Prospective monocenter single-blind randomized (1:1) investigator sponsored clinical trial, in which consecutive patients candidates for percutaneous intervention of angioplasty to treat symptomatic in-stent restenosis of the SFA…
- Trial name
- PACUBA 1 (NCT01247402)
- Testing
- drug eluting balloon angioplasty, standard balloon angioplasty
- Where
- 2 sites in Austria
- Volunteers
- 60 people
- Sponsor
- Medical University of Vienna
Common Femoral Artery Stenosis, Calcification; Heart
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
The investigators hypothesize that Shockwave with DCB is non-inferior to surgical endarterectomy for common femoral artery (CFA) stenosis with regard to primary efficacy and safety endpoints.
- Trial name
- Shockify (NCT06829914)
- Testing
- Shockwave Catheter, CFA Endarterectomy
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Baylor Research Institute
Peripheral Vascular Disease
Belgian Prospective Multicentre Registry on the Performance of the Smart Stent in the Superficial Femoral Artery According to the New Tasc II-classification
This is a Belgian prospective multicentre registry on the performance of the Smart stent in the superficial femoral artery according to the new tasc II-classification.
- Trial name
- NCT00496041
- Testing
- Registry
- Where
- Belgium
- Volunteers
- 205 people
- Sponsor
- University Hospital, Ghent
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
SELUTION4SFA Trial
This study aims to demonstrate the safety and efficacy of the SELUTION SLR™ 018 DEB compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA)…
- Trial name
- NCT05132361
- Testing
- SELUTION SLR™ 018 DEB, Plain (Uncoated) Balloon Angioplasty (PTA)
- Where
- 38 sites in United States, Austria and 2 more
- Volunteers
- 300 people
- Sponsor
- M.A. Med Alliance S.A.
Peripheral Artery Disease, Femoropopliteal Stenosis
Histological Segmentation of the Superficial Femoral Artery From Microscan to CT Using Artificial Intelligence
The femoropopliteal artery segment (FPAS) is one of the longest arteries in the human body, undergoing torsion, compression, flexion and extension due to lower limb movements.
- Trial name
- CTPred (NCT06260488)
- Testing
- Endovascular surgery
- Where
- France
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University Hospital, Strasbourg, France
Aortic Stenosis, Aortic Valve Disease
Radial Versus Femoral Secondary Access During TAVI
The R-TAVI study is a randomized pilot study examining the use of the right radial artery versus the femoral artery for secondary vascular access during transcatheter aortic valve implantation (TAVI).
- Conditions
- Aortic Stenosis, Aortic Valve Disease, Vascular Access Complication
- Trial name
- R-TAVI (NCT03879824)
- Testing
- Secondary Radial Artery Access, Secondary Femoral Artery Access
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Carilion Clinic
Atherosclerosis of the Peripheral Arteries
Pilot Randomized Clinical Study of the Iliac Arteries and Common Femoral Artery With Stenting and the Iliac Arteries With Stenting and Plasty of the Common Femoral Artery
According to the recommendations of the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) statement and the Russian guidelines for limb ischemia treatment (2010), reconstructive surgery is…
- Trial name
- TASC CD (NCT03315884)
- Testing
- Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA), Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch
- Where
- Russia
- Volunteers
- 60 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Peripheral Arterial Disease
Multi-center Study for Stent Graft System for Peripheral Artery
The utility of GP1101 will be evaluated relative to that of surgical bypass in the treatment of Femoral/Popliteal Arterial Symptomatic Peripheral Arterial Disease.
- Trial name
- VJH11-01 (NCT01575808)
- Testing
- GP1101
- Where
- 15 sites in Japan
- Volunteers
- 133 people
- Sponsor
- W.L.Gore & Associates
Vascular Complications
Retrospective Analysis of Balloon Expandable Covered Stenting in the Common Femoral Artery
The aim of this study is to evaluate the safety and efficacy of balloon expandable covered stenting of access complications, stenoses or pseudoaneurysms of the common femoral access.
- Trial name
- BEST-CFA (NCT05220540)
- Where
- 3 sites in Hungary
- Volunteers
- 24 people
- Sponsor
- Semmelweis University Heart and Vascular Center