Clinical trials: Femoral Arterial Stenosis
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, Angioplasty
an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified Lesions
This is a prospective, single-center, single-arm, observational study. It plans to enroll 58 patients with moderate to severely calcified lesions in the femoropopliteal or infrapopliteal arteries.
- Conditions
- Femoral Artery Stenosis, Angioplasty, Cutting Balloon Angioplasty, Calcifications, Vascular
- Trial name
- DkuLL CALVEP (NCT07397390)
- Testing
- DKutting LL scoring balloon angioplasty
- Where
- China
- Volunteers
- 58 people
- Sponsor
- The First Affiliated Hospital of Dalian Medical University
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries
The aim of this study is to demonstrate the superiority in safety and efficacy of the Legflow DCB vs standard uncoated POBA in a randomized controlled (RCT) for treatment of patients with symptomatic peripheral artery disease…
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Angiopathy, Peripheral
- Trial name
- SIGNATURE (NCT04971772)
- Where
- 11 sites in Brazil, Germany and 1 more
- Volunteers
- 150 people
- Sponsor
- Cardionovum GmbH
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.
Lower Limb Ischemia, Peripheral Arterial Disease
The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)
The SupPORT Registry aims at collecting real-world from Portuguese centers performing femoral-popliteal revascularization with Supera (r) implants. This is a prospective non-randomized non-controlled consecutive registry.
- Conditions
- Lower Limb Ischemia, Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Chronic Limb Ischemia
- Trial name
- SupPORT regist (NCT06416644)
- Testing
- Supera Vasculomimetic Stent
- Where
- 15 sites in Portugal
- Volunteers
- 100 people
- Sponsor
- Hospital do Divino Espírito Santo de Ponta Delgada
Popliteal Artery Stenosis Above the Knee, Peripheral Artery Disease
STAR-PAK Study: Evaluating the Safety and Efficacy of PAK® (Paclitaxel Coated Balloon) in Treating Atherosclerotic Femoro-Popliteal Lesions
The primary objective of the study is to evaluate the performance and the safety of the PAK® DCB Catheter in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and/or popliteal arteries…
- Conditions
- Popliteal Artery Stenosis Above the Knee, Peripheral Artery Disease, Superficial Femoral Artery Stenosis
- Trial name
- STAR-PAK (NCT06734221)
- Testing
- Paclitaxel Coated Peripheral Angioplasty Balloon Catheter
- Where
- 3 sites in Poland, Spain
- Volunteers
- 120 people
- Sponsor
- Balton Sp.zo.o.
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
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
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
Assessment of Superficial Femoral Artery Lesions With FFR From the ACIST Navvus® Catheter
This study is intended to help establish standard procedures for use of FFR in the peripheral arterial system and to evaluate the correlation of post-procedural FFR values and clinical outcomes in Superficial Femoral artery (SFA)…
- Trial name
- FLO THRU (NCT05079906)
- Testing
- Fractional Flow Reserve (FFR), High Definition Intravascular Ultrasound (HD-IVUS)
- Sponsor
- Acist Medical Systems
Peripheral Arterial Disease, Peripheral Artery Disease
Digital Variance Angiography in Diagnostic Angiographies for Effective Radiation Dose Reduction
Digital Variance Angiography (DVA) is a new tool in medical imaging with proven image quality reserve. The previously observed quality reserve of Digital Variance Angiography (DVA) in lower extremity angiographies, allowed to…
- Conditions
- Peripheral Arterial Disease, Peripheral Artery Disease, Femoral Artery Stenosis, Femoral Artery Occlusion
- Trial name
- NCT04343196
- Testing
- Diagnostic Angiography (DSA or DVA based on randomization result)
- Where
- Hungary
- Volunteers
- 114 people
- Sponsor
- Kinepict Health Ltd.
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
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.
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
Femoral Artery Occlusion, Femoral Arterial Stenosis
Lutonix® DCB for Treatment of Long Lesions in Femoropopliteal Arteries
To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA
- Trial name
- NCT02013271
- Testing
- Lutonix Paclitaxel Drug Coated Balloon (DCB)
- Where
- 14 sites in Austria, Belgium and 3 more
- Volunteers
- 125 people
- Sponsor
- C. R. Bard
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
Study of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and /or Occlusion
Evaluation of drug eluting peripheral vascular stent system for the treatment of superficial femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical performance compared with similar products…
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Superficial Femoral Artery Occlusion
- Trial name
- NCT03121430
- Testing
- Drug eluting peripheral vascular stent system, Nitinol Stent System
- Where
- China
- Volunteers
- 138 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
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, 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
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
Iliac Artery Stenosis, Iliac Artery Occlusion
Safety and Efficacy Study of GoldenFlow Peripheral Stent System
A Prospective, Multi-center, Single-Arm Clinical Trial to evaluate the safety and efficacy of the GodenFlow Peripheral Stent System manufactured by Lifetech Scientific (Shenzhen) Co., LTD.
- Conditions
- Iliac Artery Stenosis, Iliac Artery Occlusion, Femoral Artery Stenosis, Femoral Artery Occlusion
- Trial name
- NCT03687983
- Testing
- GoldenFlow Peripheral Stent System
- Where
- 12 sites in China
- Volunteers
- 90 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Carotid Stenosis, Femoral Arterial Stenosis
Use of Amplified Sound Signal to Identify Presence of Carotid and Femoral Stenosis
The purpose of the study is to test a new amplified stethoscope(AudioDoc) that can detect the presence of bruit by using an acoustic signal to represent the bruit.
- Conditions
- Carotid Stenosis, Femoral Arterial Stenosis, Carotid Bruit Asymptomatic, Carotid Murmur
- Trial name
- NCT01599195
- Testing
- AudioDoc
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Albert Einstein Healthcare Network