Clinical trials: Femoral Artery Stenosis
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, Claudication, Intermittent
Arterial Imaging of Inflammation and Resolution After Endovascular Surgery
This study evaluates the local inflammatory and resolution response of patients undergoing peripheral vascular intervention like an angioplasty of the superficial femoral artery (SFA) or popliteal artery, or stenting of the iliac…
- Conditions
- Peripheral Arterial Disease, Claudication, Intermittent, Claudication, PAD
- Trial name
- AIIRES (NCT03590769)
- Testing
- 18F-FDG
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- University of California, San Francisco
Aortic Stenosis
Femoral vs Radial Approach and MRI Evaluation of Strokes
Symptomatic cerebral infarction following cardiac catheterization is rare but silent brain injury could occur at an unexpectedly high rate.
- Trial name
- NCT00329979
- Testing
- vascular access site
- Where
- France
- Volunteers
- 152 people
- Sponsor
- University Hospital, Caen
Peripheral Arterial Disease
Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System
The primary objective is to demonstrate the safety and effectiveness of the Axys EX rotational atherectomy system in subjects with peripheral arterial disease who have de novo or non-stented restenotic obstructive lesions in the…
- Trial name
- Axys ACHIEVE (NCT04282161)
- Testing
- Axys EX device
- Sponsor
- Medtronic Endovascular
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.
Artery Stenosis, Carotid, Artery Stenosis
A Retrospective, Observational, Multicentre, Study to Evaluate the Safety and Performance of POLYPATCH ® Vascular Patch
POLYPATCH® study is RWE multicentre study which examine short and long-term outcomes of using POLYPATCH® when exposed to a larger and more varied population.
- Conditions
- Artery Stenosis, Carotid, Artery Stenosis, Occlusion of Artery, Stroke
- Trial name
- NCT04643743
- Testing
- Endarterectomy
- Where
- France
- Volunteers
- 198 people
- Sponsor
- Perouse Medical
Superficial Femoral Artery Stenosis, Atherosclerosis of Femoral Artery
Efficacy of the EPIC Nitinol Vascular Stent System in Superficial Femoral Artery (SFA) Lesions
This is a national, prospective, multi-center, non-randomized study to evaluate the long-term efficacy and integrity of the EPICTM Nitinol Vascular Stent System in Superficial Femoral Artery (SFA) lesions.
- Trial name
- EPIC SFA BR (NCT01327950)
- Where
- 6 sites in Brazil
- Volunteers
- 86 people
- Sponsor
- Endovascular Consultoria Limitada
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
Peripheral Vascular Disease
A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery
OSPREY is a multi-center, single arm, non-randomized, prospective clinical trial. Subjects will undergo a superficial femoral artery (SFA) stent procedure using the Misago™ Peripheral Self Expanding stent once all of the…
- Trial name
- OSPREY (NCT01118117)
- Testing
- Misago™ Self-Expanding Stent System
- Where
- 31 sites in United States
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Terumo Medical Corporation
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
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.
Carotid Artery Stenosis Without Infarction (Disorder), Ischemic Stroke
Brachial Versus Femoral Access for Carotid Artery Stenting
Study purpose: A multicenter, prospective and randomized study is planned to compare the clinical outcomes of carotid artery stenting via brachial artery access and femoral artery access.
- Trial name
- BEFIT (NCT06557135)
- Testing
- Carotid Artery Stenting (CAS)
- Where
- China
- Volunteers
- 235 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
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
Femoral Artery Stenosis, Popliteal Artery Stenosis
IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)
The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral arterial disease (PAD) in the superficial…
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- INPACT SFA II (NCT01566461)
- Testing
- Drug-Coated Balloon (DCB), PTA Balloon: Balloon Angioplasty
- Where
- 2 sites in United States
- Volunteers
- 331 people
- Sponsor
- Medtronic Endovascular
Superficial Femoral Artery Stenosis, Iliac Artery Occlusion
Full Metall Jacket Multilevel Segment
Hypothesis: "Total" endovascular revascularization of a multistory lesion of the iliac-femoral-popliteal segment is safer and a better quality of life is achieved in comparison with hybrid intervention.
- Trial name
- FMJSFA (NCT04461496)
- Testing
- Hybrid revascularization, Full metall Jacket
- Where
- Russia
- Volunteers
- 100 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Peripheral Arterial Disease, Iliac Artery Stenosis
Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion
Clinical study on safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter in the treatment of iliac, femoral and popliteal artery stenosis or occlusion
- Conditions
- Peripheral Arterial Disease, Iliac Artery Stenosis, Femoral Artery Stenosis, Popliteal Artery Stenosis
- Trial name
- NCT03844724
- Testing
- ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter, Peripheral Balloon Dilatation Catheter
- Volunteers
- 204 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Femoral Artery Stenosis, Femoral Artery Occlusion
Safety and Efficacy Study of FemFlow Drug-Eluting Peripheral Balloon Catheter
A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of FemFlow Drug-Eluting Peripheral Balloon Catheter manufactured by Lifetech Scientific (Shenzhen) Co., LTD.
- Conditions
- Femoral Artery Stenosis, Femoral Artery Occlusion, Popliteal Arterial Stenosis, Popliteal Artery Occlusion
- Trial name
- NCT03683459
- Testing
- FemFlow Drug-Eluting Peripheral Balloon Catheter
- Where
- 18 sites in China
- Volunteers
- 208 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Femoral Artery Stenosis, Femoral Artery Occlusion
Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).
- Conditions
- Femoral Artery Stenosis, Femoral Artery Occlusion, Restenosis
- Trial name
- SFA ISR (NCT02063672)
- Testing
- Lutonix DCB, Standard Uncoated Balloon Angioplasty Catheter
- Where
- 20 sites in United States
- Volunteers
- 82 people
- Sponsor
- C. R. Bard
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
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.