Clinical trials: Peripheral Arterial Diseases
Intermittent Claudication
BE Study of Once Daily PMR Compared to Twice Daily Cilostazol Tablets in Healthy Volunteers
The study is designed to evaluate the bioequivalence and the within-subject variability between the test formulation of extended-release tablet of cilostazol (PMR) administered once daily and the reference formulation of…
- Trial name
- NCT06167265
- Testing
- Cilostazol Tablet 100 mg, PMR Tablet 145 mg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Genovate Biotechnology Co., Ltd.,
Peripheral Arterial Disease, Critical Lower Limb Ischemia
Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon
To evaluate the safety and performance of the Sundance™ DCB in subjects with occlusive disease of the infrapopliteal arteries.
- Trial name
- SWING (NCT04107298)
- Testing
- SUNDANCE™ Drug Coated Balloon
- Where
- 8 sites in Australia, Austria and 3 more
- Volunteers
- 35 people
- Sponsor
- SurModics, 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
Peripheral Artery Disease
ILLUMENATE Pivotal Post-Approval Study (PAS)
The ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects from forty-three (43) sites across the United States and Austria previously enrolled in the ILLUMENATE Pivotal pre-market study to evaluate…
- Trial name
- NCT03421561
- Testing
- Stellarex 0.035" OTW Drug-coated Angioplasty Balloon, EverCross™ 0.035 PTA Balloon Catheter
- Where
- 41 sites in United States, Austria
- Volunteers
- 300 people
- Sponsor
- Spectranetics Corporation
Peripheral Arterial Disease
ILLUMENATE Below-The-Knee (BTK) Arteries: a Post Market Clinical Study
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the StellarexTM 0.014" OTW Drug-coated Angioplasty Balloon in the treatment of lesions in "below the…
- Trial name
- BTK PMS (NCT03395236)
- Testing
- StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty Balloon
- Where
- 10 sites in Germany, Netherlands and 1 more
- Volunteers
- 49 people
- Sponsor
- Spectranetics Corporation
Coronary Artery Disease, Peripheral Arterial Disease
Evaluate Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions
This is a prospective, multi-center, single-group post-market study. It is planned to be carried out in about 3 clinical institutions, and a total of 60 subjects are expected to be enrolled.
- Trial name
- NCT05747287
- Testing
- microcatheter
- Where
- 3 sites in China
- Volunteers
- 60 people
- Sponsor
- BrosMed Medical Co., Ltd
PAD - Peripheral Arterial Disease
Feasibility Study of the Vessel Restoration System (VRS): ACTIVATE II
Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA): ACTIVATE II
- Trial name
- ACTIVATEII (NCT05454995)
- Testing
- Vessel Restoration System (VRS)
- Where
- Australia
- Volunteers
- 50 people
- Sponsor
- Alucent Biomedical
PAD - Peripheral Arterial Disease
Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Popliteal Artery (PA) After Sub-optimal Percutaneous Transluminal Angioplasty (PTA) or Atherectomy: REACTIVATE I
Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Popliteal Artery (PA) after Sub-optimal percutaneous transluminal angioplasty…
- Trial name
- REACTIVATE I (NCT05455021)
- Testing
- Vessel Restoration System (VRS)
- Where
- 2 sites in Australia
- Volunteers
- 50 people
- Sponsor
- Alucent Biomedical
Peripheral Arterial Disease, Vascular Disease, Peripheral
Disrupt PAD+ Study With the Shockwave Medical M5+ Peripheral IVL System
Prospective, multi-center, single-arm study of the M5+ Peripheral IVL system to treat calcified peripheral arteries.
- Trial name
- Disrupt PAD+ (NCT04585763)
- Testing
- Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL)
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 37 people
- Sponsor
- Shockwave Medical, Inc.
Peripheral Arterial Disease
Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)
Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to…
- Trial name
- NCT02923193
- Testing
- Shockwave Lithoplasty® Peripheral Lithoplasty System, Medtronic IN.PACT (DCB)
- Where
- 54 sites in United States, Austria and 2 more
- Volunteers
- 306 people
- Sponsor
- Shockwave Medical, Inc.
Peripheral Artery Disease
BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions
BIOTRONIK cobalt chromium balloon-expandable Dynetic-35 stent in association with Passeo-35 Xeo peripheral dilation catheter for the treatment of peripheral iliac lesions
- Trial name
- BIONETIC-I (NCT04830228)
- Testing
- Ballon expandable stent and PTA
- Where
- 15 sites in Austria, Belgium and 4 more
- Volunteers
- 160 people
- Sponsor
- Biotronik AG
Peripheral Vascular Disease (PVD), Peripheral Arterial Disease (PAD)
A Clinical Trial to Evaluate the Efficacy and Safety of a Spot Stent System Used in Femoropopliteal Arteries.
A prospective randomized trial designed to compare the efficacy and safety of spot stent system versus self-expanding peripheral stent system in the endovascular treatment of femoropopliteal arterial stenotic disease.
- Trial name
- NCT05246410
- Testing
- Spot stent system, Self-expanding peripheral stent system
- Where
- 2 sites in China
- Volunteers
- 196 people
- Sponsor
- Acotec Scientific Co., Ltd
Critical Limb Ischemia
ACP-01 in Patients With Critical Limb Ischemia
The primary objective of this study is to determine the efficacy and safety of intramuscular injection of ACP-01, comprised of blood-derived autologous ACPs, in subjects with critical limb ischemia who are receiving standard of…
- Trial name
- NCT02551679
- Testing
- ACP-01
- Where
- 19 sites in United States, Canada
- Volunteers
- 67 people
- Sponsor
- Hemostemix
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.
Peripheral Artery Disease (PAD), Ischemia
The Chocolate Touch Study
The Chocolate Touch study is a randomized, multi-center, prospective, adaptive study, designed to show sufficient safety and effectiveness of the Chocolate Touch™ for use in superficial femoral or popliteal arteries with the…
- Conditions
- Peripheral Artery Disease (PAD), Ischemia, Intermittent Claudication
- Trial name
- NCT02924857
- Testing
- Chocolate Touch, Lutonix Drug Coated Balloon
- Where
- 20 sites in United States, Austria and 2 more
- Volunteers
- 333 people
- Sponsor
- TriReme Medical, LLC
Coronary Artery Disease, Peripheral Artery Disease
A Study to Collect Data on the Treatment Pattern of Xarelto + Acetylsalicylic Acid in the Routine Clinical Practice in Patients Who Are Suffering From a Condition That Narrows the Blood Vessels Supplying the Heart and / or a Condition That Most Commonly Narrows the Blood Vessel in the Legs
The study will focus on effectiveness and safety of rivaroxaban (Xarelto) when given together with acetylsalicylic acid (combination therapy) to patients suffering from coronary artery disease (a condition that affects the blood…
- Trial name
- XATOC (NCT04401761)
- Testing
- Rivaroxaban (BAY59-7939, Xarelto), Acetylsalicylic acid
- Where
- 10 sites in Belgium, China and 8 more
- Volunteers
- 3,189 people
- Sponsor
- Bayer
Peripheral Arterial Disease
AndraValvulotome Post-Market Study
The AndraValvulotome Post-Market Study is a prospective, open-label, multi-center study to evaluate the efficacy and safety of the AndraValvulotome.
- Trial name
- NCT04815473
- Testing
- Valvulotomy
- Where
- 4 sites in Germany
- Volunteers
- 59 people
- Sponsor
- Andramed GmbH
Peripheral Artery Disease
Acoart SCB SFA: Sirolimus Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis
A prospective randomized trial designed to compare the efficacy and safety of Sirolimus coated balloon (SCB) versus paclitaxel coated balloon (DCB) in the treatment of femoropopliteal artery stenosis
- Trial name
- NCT04982367
- Testing
- Sirolimus-eluting balloon catheter, Paclitaxel-eluting balloon catheter
- Where
- China
- Volunteers
- 166 people
- Sponsor
- Acotec Scientific Co., Ltd
Peripheral Artery Disease, Vascular Disease
In-Stent Restenosis Post-Approval Study
The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.
- Trial name
- NCT02542267
- Testing
- Gore VIABAHN Endoprosthesis
- Where
- 23 sites in United States, Germany and 2 more
- Volunteers
- 108 people
- Sponsor
- W.L.Gore & Associates
Peripheral Arterial Disease
ChampioNIR® SFA Stent EFS Study
An Early Feasibility Study to Assess Safety and Efficacy of the ChampioNIR® SFA Stent in the Treatment of Patients with Femoro-Popliteal Disease
- Trial name
- NCT03775226
- Testing
- ChampioNIR® SFA Stent
- Where
- 3 sites in Israel
- Volunteers
- 22 people
- Sponsor
- Medinol Ltd.