Clinical trials: Femoral Artery Occlusion
Peripheral Artery Disease, Peripheral Vascular Disease
Study to Determine the Performance of the Astron and Pulsar-18 Stents in Europe
BIOFLEX-I EU is the European arm of the BIOFLEX-I IDE study (NCT01319812). Data from BIOFLEX-I EU will be pooled with data in the IDE.
- Trial name
- BIOFLEX-I EU (NCT01661231)
- Testing
- Astron/Pulsar-18 stent
- Where
- 7 sites in Austria, Belgium and 2 more
- Volunteers
- 456 people
- Sponsor
- Biotronik AG
Femoral Artery Stenosis, Popliteal Artery Stenosis
CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery
The CVT-SFA Trial investigates the inhibition of restenosis using the CVT Everolimus-coated PTA Catheter in the treatment of de-novo occluded/ stenotic or re-occluded/restenotic superficial femoral or popliteal arteries.
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- NCT05734157
- Testing
- Peripheral PTA with a drug coated balloon
- Where
- 8 sites in France, Germany
- Volunteers
- 75 people
- Sponsor
- Abbott Medical Devices
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
Peripheral Arterial Disease (PAD)
Post-marketing Study in Femoral Popliteal Artery of Drug Coated Balloon Used for Treatment of Lower Limb Ischemia
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Drug-coated Balloon catheters in the treatment of the Superficial Femoral Artery (SFA) and Popliteal…
- Trial name
- UltraFuture I (NCT05498740)
- Testing
- Drug eluting Balloon
- Where
- 24 sites in China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
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.
Myocardial Infarction, Coronary Artery Diseases
Physical and Chemical Study of Atherosclerosis Mechanisms
Study the mechanisms of atherosclerosis based on a comparative study of physical and chemical properties of lipid tissues at various localization with subsequent development of concept of treatment and prevention.
- Conditions
- Myocardial Infarction, Coronary Artery Diseases, Diabetes Mellitus, Type 2, Atherosclerosis of Femoral Artery
- Trial name
- PCSAM (NCT01700075)
- Testing
- Conventional treatment, Weight loss treatment
- Where
- Kazakhstan
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Nazarbayev University
Arterial Occlusive Diseases
The Study to Compare the Cordis SMART™ Stent System With the Bard® Luminexx™ Stent
This study will look at the performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System for the treatment of TASC C \& D superficial femoral artery long lesions (up to 22 cm) in comparison with the Bard® Luminexx™ 6F…
- Trial name
- SUPER SL (NCT00235131)
- Testing
- Smart Stent, Luminexx Stent
- Where
- 2 sites in Germany
- Volunteers
- 200 people
- Sponsor
- Cordis US Corp.
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.
Peripheral Arterial Disease
HORIZON Prospective Clinical Investigation
The objective of this clinical investigation is to demonstrate and provide long term clinical data on safety and performance of the Exist 6F NiTi stent system type FLEX \& PULL in a prospective investigation for the treatment of…
- Trial name
- NCT05234164
- Testing
- EXIST 6F NiTi Stent System FLEX, EXIST 6F NiTi Stent System PULL
- Where
- 2 sites in Italy, Poland
- Volunteers
- 69 people
- Sponsor
- Qmedics AG
Chronic Total Occlusion of Artery of the Extremities
Balloon Angioplasty Versus Primary Stenting for the Treatment of Femoropopliteal Artery Chronic Total Occlusions
This is a multicenter double-arm randomized trial investigating plain balloon angioplasty versus primary placement of self-expanding nitinol stents after endovascular recanalization of femoral CTOs.
- Trial name
- FACTORY (NCT01268722)
- Testing
- Balloon angioplasty, Primary stenting
- Where
- 5 sites in Greece, Italy and 1 more
- Volunteers
- 150 people
- Sponsor
- University of Patras
Coronary Artery Disease, Coronary Angiography
HEMOSTATİC PAD AND SANDBAG
The aim of this study is to compare bleeding outcomes, pain, comfort levels, sleep quality, and associated factors among patients receiving a chitosan-based hemostatic pad versus a sandbag following femoral coronary angiography…
- Conditions
- Coronary Artery Disease, Coronary Angiography, Vascular Access Site Complications
- Trial name
- NCT07771127
- Testing
- Chitosan-Based Hemostatic Pad, Sandbag Application
- Where
- Turkey (Türkiye)
- Volunteers
- 480 people
- Sponsor
- Uludag University
Peripheral Vascular Diseases
Clinical Study on the Effectiveness and Safety Evaluation of Directional Atherectomy Combined With Drug-coated Balloons
DCB can maximize the patency rate of blood vessels on the basis of intraluminal DA. DA+DCB treatment is effective and safe [8], and the advantages of DA and DCB in the treatment of severe calcification and occlusive disease…
- Trial name
- Remove (NCT04986098)
- Testing
- TurboHawk, Paclitaxel
- Where
- China
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Soochow University
Peripheral Artery Disease (PAD)
Results of the Treatment of Medium and Long de Novo and Restenotic Lesions in the Superficial Femoral Artery and/or Popliteal Artery With Primary or Salvage Pulsar® -18 t3 Stent
The purpose of this post-authorization registry is to describe the clinical outcomes of de novo and restenotic lesions in the superficial femoral and/or popliteal artery treated with the PULSAR® -18 T3 stent, implanted both…
- Trial name
- T3PROJECT (NCT05665816)
- Testing
- Stent PULSAR® -18 T3,
- Volunteers
- 100 people
- Sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Arterial Occlusive Diseases
The Study to Treat Superficial Femoral Artery Occlusions.
The main objective of this study is to assess the performance of the Cordis SMART™ nitinol self-expandable stent for the treatment of superficial femoral artery (SFA) occlusions in comparison with balloon angioplasty only as…
- Trial name
- SUPER UK (NCT00232843)
- Testing
- stent, angioplasty
- Where
- 2 sites in United Kingdom
- Volunteers
- 150 people
- Sponsor
- Cordis US Corp.
Dyslipidemia, Atherosclerosis
Effects of Nicotinic Acid Plus Simvastatin Versus Simvastatin Alone on Carotid and Femoral Intima-Media Thickness in Patients With Peripheral Artery Disease (NASCIT)
Dyslipidaemia is characterized by low plasma levels of high-density lipoprotein cholesterol (HDL-c), elevated triglycerides and an increase in low density lipoprotein (LDL-c) particles, and has been unequivocally established as a…
- Trial name
- NASCIT (NCT00712049)
- Testing
- simvastatin, Nicotinic Acid
- Where
- Austria
- Volunteers
- 200 people
- Sponsor
- Medical University of Vienna
Aorta-iliac Segment Lesion (C,D Type by TASC II)
Study of the AFB and Stenting of the Iliac Arteries
The aim of the study is to compare effectiveness and long-term results of aorta-femoral reconstructions and endovascular treatment in the patients with aorta-iliac lesions (TASC C,D).
- Trial name
- NCT02209350
- Testing
- Aorta-femoral bypass, Recanalization and stenting of aorta-iliac segment, Therapy: aspirin and clopidogrel
- Where
- Russia
- Volunteers
- 202 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Peripheral Arterial Disease
Clinical Trial Investigating the Efficacy of the Supera Peripheral Stent System for the Treatment of the Common Femoral Artery
The VMI-CFA study investigates the efficacy of the Supera Stent in the treatment of common femoral artery stenosis or occlusion. 100 patients will be included with a RF of 2 to 4.
- Trial name
- VMI-CFA (NCT02804113)
- Testing
- Supera Peripheral Stent System
- Where
- 7 sites in Belgium, France
- Volunteers
- 100 people
- Sponsor
- ID3 Medical
Peripheral Arterial Disease
PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis
Nowadays, stenting is became a standard of care in revascularization for superficial femoral artery (SFA) atherosclerotic lesions. However, the Achilles' heel of this technique remains in-stent restenosis (ISR).
- Trial name
- PLAISIR (NCT01587482)
- Testing
- PacLitaxel Eluting Balloon Application
- Where
- France
- Volunteers
- 53 people
- Sponsor
- Nantes University Hospital