Clinical trials: Femoral Arterial Stenosis, active
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
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
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
- 34 sites in United States, Austria and 2 more
- Volunteers
- 300 people
- Sponsor
- M.A. Med Alliance S.A.
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 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
Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
The primary purpose of this study is to observe reduced access site complications in patients with heavily calcified common femoral arteries requiring Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- NCT07205068
- Testing
- Shockwave M5 IVL Catheter, Modified Seldinger Technique
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Tennessee Graduate School of Medicine
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
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
Superficial Femoral Artery Stenosis, Claudication
Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions
This is a common care study. A study for evaluating the quality of balloon inflation and stent application will be performed in 2D angiography alone in the control group and then by 2D and OCT angiography for the experimental…
- Conditions
- Superficial Femoral Artery Stenosis, Claudication, Ischemic Leg
- Trial name
- TOCAF (NCT04434586)
- Testing
- femoropopliteal revascularization for TASC C or TASC D lesion
- Where
- France
- Volunteers
- 166 people
- Sponsor
- University Hospital, Lille
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 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.
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.