Clinical trials: Superficial Femoral Artery Disease
Superficial Femoral Artery Disease, Popliteal Artery Disease
Prospective Multicenter Study to Confirm the Performance of the Renzan Stent in Treatment of SFA/POP Artery Disease
The primary objective of this study is to confirm the safety and efficacy of the RenzanTM Peripheral Stent System when used for treatment of superficial femoral (SFA) and/or popliteal (POP) artery disease.
- Trial name
- PRIZER (NCT04546477)
- Testing
- Stent implantation
- Where
- 13 sites in Belgium, France and 3 more
- Volunteers
- 135 people
- Sponsor
- Terumo Europe N.V.
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
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, 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, 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, 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
Atherosclerotic Ischemic Disease, Critical Limb Ischemia
Efficacy and Safety Comparison of the Open and Endovascular Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Below the Knee, TASC D in Patients With Critical Limb Ischemia
This is prospective, randomized study. The main objective of the study is to compare the clinical efficacy and safety of two therapies for the treatment of prolonged atherosclerotic lesions of the arteries of the femoropopliteal…
- Conditions
- Atherosclerotic Ischemic Disease, Critical Limb Ischemia, Superficial Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- NCT04583436
- Testing
- Endovascular recanalization, Open surgery
- Where
- Russia
- Volunteers
- 90 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Atherosclerosis, Peripheral Arterial Disease
Stella Supera Siberia
Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal lesions. This technique tends to extend to lesions for which the gold standard remains until now the open surgery treatment (lesions TASC…
- Conditions
- Atherosclerosis, Peripheral Arterial Disease, Superficial Femoral Artery Occlusion
- Trial name
- NCT03951727
- Testing
- Endovascular treatment for PAD
- Where
- Russia
- Volunteers
- 50 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
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 Lesions, Atherosclerosis of Femoral Artery
480 Biomedical Bioresorbable Scaffold System in the Treatment of de Novo Superficial Femoral Artery (SFA) Lesions
This is an initial evaluation of the 480 Biomedical Bioresorbable Scaffold System for the treatment of subjects with de novo native superficial femoral artery lesions.
- Trial name
- STANCE (NCT01403077)
- Testing
- 480 Biomedical Bioresorbable Scaffold System
- Where
- 6 sites in Australia, Austria and 2 more
- Volunteers
- 46 people
- Sponsor
- 480 Biomedical
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.
Stable Claudication (Fontaine IIa and IIb), Superficial Femoral Artery Disease
Primary Stenting vs Conservative Treatment in Claudicants - a Study on Quality of Life
The aim of this study is to evaluate whether primary stenting with self expanding stent in patients with peripheral arterial disease suffering from stable claudication due to superficial femoral artery disease results in improved…
- Conditions
- Stable Claudication (Fontaine IIa and IIb), Superficial Femoral Artery Disease, Best Medical Treatment, Quality of Life Scores at 12 and 24 Months
- Trial name
- NCT01230229
- Testing
- Stenting, Best medical treatment
- Where
- 2 sites in Sweden
- Volunteers
- 100 people
- Sponsor
- Lund University
Peripheral Arterial Diseases, Superficial Femoral Artery Stenosis
Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent
The intent of this clinical registry is to demonstrate the efficacy of the EPIC™ stent in patients with superficial femoral/ popliteal artery disease.
- Trial name
- SUMMIT (NCT01336101)
- Testing
- EPIC™ Self-Expanding Nitinol Vascular Stent
- Where
- 4 sites in Germany
- Volunteers
- 100 people
- Sponsor
- Provascular GmbH
Superficial Femoral Artery Disease
S.M.A.R.T.® Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease
A multi-center, non-randomized, single-arm, prospective trial evaluating the safety and effectiveness of the S.M.A.R.T.™ Nitinol Stent System implantation in approximately 250 patients with obstructive superficial femoral artery…
- Trial name
- STROLL (NCT00739102)
- Testing
- S.M.A.R.T. ® Stent
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Cordis US Corp.