Clinical trials: Infrapopliteal Arterial Occlusive Disease
Arterial Occlusive Disease
Infrapopliteal Drug Eluting Angioplasty Versus Stenting
In total 50 patients diagnosed with long-segment infrapopliteal arterial disease will be randomized in two groups. The patients randomized in the Drug coated balloons (DCB) study arm will undergo a percutaneous transluminal…
- Trial name
- IDEAS-I (NCT01517997)
- Testing
- Paclitaxel coated balloon angioplasty., Infrapopliteal Primary Drug Eluting Stenting
- Where
- Greece
- Volunteers
- 50 people
- Sponsor
- University of Patras
Infrapopliteal Lesions, Critical Limb Ischemia
IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial
The goal of this prospective, multicentre, single arm clinical trial is to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with…
- Trial name
- NCT05971394
- Testing
- Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
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 Diseases
Comparing Angioplasty and DES in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease
The primary objective of this study is to compare the performance of the CYPHER SELECTTM + Sirolimus-eluting Balloon-expandable Coronary and Infrapopliteal Stent over balloon angioplasty in de novo and restenotic native below the…
- Trial name
- ACHILLES (NCT00640770)
- Testing
- balloon angioplasty, drug eluting stent
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Cordis US Corp.
Peripheral Arterial Disease
Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone in Europe
The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon angioplasty safe and effective in treating lower limb blockages.
- Trial name
- AMBITION BTK (NCT07472439)
- Testing
- Auryon Atherectomy System, Balloon Angioplasty
- Volunteers
- 50 people
- Sponsor
- Angiodynamics, Inc.
Chronic Limb-Threatening Ischemia
Esprit BTK Post-Approval Study
The Esprit BTK PAS is a prospective, single-arm, multi-center observational study to assess the continued safety and effectiveness of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System under commercial use, in patients…
- Trial name
- EspritBTKPAS (NCT06656364)
- Testing
- Esprit BTK System
- Where
- 39 sites in United States, Hong Kong and 2 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Critical Limb Ischemia, Peripheral Arterial Occlusive Disease
Cryoplasty CLIMB-registry
In 5 Belgian hospitals, the data of 100 CLI-patients receiving the cryoplasty technique to treat their infrapopliteal arterial lesions will be collected.
- Trial name
- CLIMB (NCT00459888)
- Testing
- PolarCath Peripheral Dilatation System (Boston Scientific)
- Where
- 4 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- Flanders Medical Research Program
Atherosclerosis, Ischemia
Clinical Of Chocolate Balloon Dilatation Versus Plain Balloon Dilatation to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
This is a Prospective randomized controlled study to evaluate the difference of safety，effectiveness between chocolate balloon and plain balloon dilatation in treatment of infrapopliteal artery lesions.
- Trial name
- NCT05158283
- Testing
- chocolate balloon, plain balloon
- Where
- China
- Volunteers
- 144 people
- Sponsor
- Xuanwu Hospital, Beijing
Peripheral Artery Disease
Trial to Assess the Safety and Efficacy of Sirolimus-Coated Balloon vs. Uncoated Standard Angioplasty for the Treatment of Below-the-knee Peripheral Arterial Disease
This study is a prospective, interventional, multicenter 1:1 randomized trial. The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with POBA (control…
- Trial name
- LIMES (NCT04772300)
- Testing
- Percutaneous Transluminal Angioplasty (PTA) MagicTouch Sirolimus Coated PTA Balloon Catheter, Percutaneous Transluminal Angioplasty (PTA) with non-coated balloon catheter (POBA)
- Where
- 19 sites in Austria, Germany
- Volunteers
- 230 people
- Sponsor
- Jena University Hospital
Chronic Limb Threatening Ischemia, Chronic Limb-Threatening Ischemia
REsorbable SCaffolds With everolimUs-Elution for the Treatment of Infrapopliteal Artery Disease in Patients With Chronic Limb-threatening Ischemia
RESCUE is a Europe-wide study that will follow 400 people with critical limb-threatening ischemia (CLTI). It aims to see how well Esprit BTK™ Everolimus Eluting Resorbable Scaffolds work in real-life medical settings.
- Trial name
- RESCUE (NCT07270575)
- Testing
- Esprit BTK™ Everolimus Eluting Resorbable Scaffold from Abbott
- Where
- United Kingdom
- Volunteers
- 400 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe
Peripheral Arterial Disease, Peripheral Arterial Disease(PAD)
Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries (BIO-OSCAR First)
The purpose of this study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications for endovascular peripheral interventions of femoral, popliteal and infrapopliteal lesions.
- Trial name
- NCT06758921
- Testing
- Oscar Peripheral Multifunctional Catheter
- Where
- 16 sites in Austria, Belgium and 6 more
- Volunteers
- 200 people
- Sponsor
- Biotronik AG
Peripheral Arterial Disease, Critical Limb-Threatening Ischaemia
Shockwave ®S4 Catheter IVL to Treat Infrapopliteal Calcified Stenoses and/or Occlusions in CLTI Patients (LEGACY)
The study will evaluate the safety and efficacy of Peripheral Intravascular Lithotripsy system with Shockwave S4 catheter® for the treatment of de novo, re-stenosis or re-occlusive,calcified chronic total occlusion (CTOs) lesions…
- Trial name
- LEGACY (NCT05755412)
- Where
- 6 sites in Italy
- Volunteers
- 9 people
- Sponsor
- EndoCore Lab s.r.l.
Chronic Limb-Threatening Ischemia
AcoArt Litos PCB Below-the-knee Global Trial
The objective of this study is to assess whether efficacy of the AcoArt Litos PCB is superior and whether safety of AcoArt Litos PCB is noninferior to the control device (FDA cleared PTA Balloon Catheter) regarding treatment of…
- Trial name
- NCT06330493
- Testing
- PCB, PTA
- Where
- 18 sites in United States, Austria and 1 more
- Volunteers
- 75 people
- Sponsor
- Acotec Scientific Co., Ltd
Peripheral Vascular Disease
PTA and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia
The purpose of this study is to investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb…
- Trial name
- PADI (NCT00471289)
- Testing
- PTA with placement of paclitaxel-eluting stent, PTA
- Where
- 3 sites in Netherlands
- Volunteers
- 144 people
- Sponsor
- Netherlands Society for Interventional Radiology
Arterial Occlusive Diseases
A Prospective Study: the Value of Using iFlow and PBV in the Endovascular Treatment of Infrapopliteal Arterial Occlusive Diseases
Color coded blood flow and blood perfusion techniques are applied to the endovascular treatment of infrapopliteal arterial occlusion,to establish a method of quantitative evaluation of blood flow and tissue perfusion,to improve…
- Trial name
- NCT03248323
- Testing
- dyna-pbv
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Peking Union Medical College Hospital
Critical Limb Ischemia, Peripheral Arterial Disease
IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA
To assess the safety and efficacy of the paclitaxel drug-coated balloon IN.PACT 014 versus conventional optimal percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the…
- Trial name
- NCT02963649
- Testing
- DCB, PTA
- Where
- 9 sites in Belgium, France and 3 more
- Volunteers
- 50 people
- Sponsor
- Medtronic Endovascular
Peripheral Arterial Diseases
Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone
The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon angioplasty safe and effective in treating lower limb blockages.
- Trial name
- AMBITION BTK (NCT06777901)
- Testing
- Auryon Atherectomy System, Balloon Angioplasty
- Where
- 9 sites in United States
- Volunteers
- 224 people
- Sponsor
- Angiodynamics, Inc.
Atherosclerosis, Peripheral Artery Disease
The ABSORB BTK (Below The Knee) Clinical Investigation
The purpose of the ABSORB BTK Clinical Investigation is to evaluate the safety and efficacy of the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS) in subjects with critical limb ischemia (CLI) following…
- Conditions
- Atherosclerosis, Peripheral Artery Disease, Peripheral Vascular Disease, PAD
- Trial name
- NCT01341340
- Testing
- Everolimus Eluting BVS
- Where
- Belgium
- Volunteers
- 2 people
- Sponsor
- Abbott Medical Devices
Peripheral Arterial Disease, Critical Limb Ischemia
A Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal ARteries Using a LIMUS-base DCB
This is a non-randomized, prospective, single center pilot study designed to evaluate the safety of the Temporary Spur Stent System to treat patients with infrapopliteal arterial disease, when used in conjunction with a…
- Trial name
- DEEPER LIMUS (NCT04162418)
- Testing
- Temporary Spur Stent System
- Where
- Austria
- Volunteers
- 26 people
- Sponsor
- ReFlow Medical, Inc.
Chronic Limb-Threatening Ischemia
Pressure Wire Guidance for Infrapopliteal Artery Interventions
"• A prospective, single-center randomized controlled comparison trial. A total of 100 patients with symptoms of chronic limb-threatening ischemia (Rutherford category 5) undergoing endovascular treatment for anterior tibial…
- Trial name
- NCT06879561
- Testing
- Angiography-guided angioplasty, Pressure wire-guided angioplasty
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Yonsei University