Clinical trials: Peripheral Artery Disease
Atherosclerosis, Peripheral Vascular Disease
A Safety and Efficacy Study of the Dynalink®-E Everolimus Eluting Peripheral Stent System
The purpose of this first-in-man study is to evaluate the safety and performance of the Dynalink®-E everolimus eluting peripheral stent system for the treatment of patients with atherosclerotic de novo or restenotic native…
- Trial name
- STRIDES (NCT00475566)
- Testing
- Dynalink®-E everolimus-eluting peripheral stent, Dynalink®-E, everolimus-eluting peripheral stent
- Where
- 10 sites in Austria, Belgium and 2 more
- Volunteers
- 104 people
- Sponsor
- Abbott Medical Devices
Peripheral Vascular Diseases
A Clinical Investigation of SM-01 Stenting Versus PTA for the Treatment of Superficial Femoral Artery Disease
The main objective is to evaluate the safety and efficacy of SM-01 stenting (Cordis S.M.A.R.T.™ Nitinol Stent System) for the treatment of SFA lesions as compared to PTA (balloon angioplasty).
- Trial name
- NCT01183117
- Testing
- SM-01, PTA
- Where
- Japan
- Volunteers
- 105 people
- Sponsor
- Johnson & Johnson K.K. Medical Company
Critical Limb Ischemia, Critical Lower Limb Ischemia
PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular…
- Conditions
- Critical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Artery Disease, Peripheral Arterial Disease
- Trial name
- PROMISE (NCT03970538)
- Testing
- LimFlow System
- Where
- 21 sites in United States, Puerto Rico
- Volunteers
- 105 people
- Sponsor
- LimFlow, Inc.
Critical Limb Ischemia (CLI)
Expanded Access for Treatment Use of PLX-PAD in Critical Limb Ischemia (CLI)
This is an Expanded Access program (EAP), sponsored by WideTrial for the treatment of critical limb ischemia (CLI). Widetrial, an Expanded Access specialist, has arranged to supply participating sites with PLX-PAD for CLI…
- Trial name
- NCT03746899
- Testing
- PLX-PAD
- Sponsor
- WideTrial, Inc.
Peripheral Arterial Disease, Peripheral Vascular Disease
BOLT Lithotripsy RESTORE BTK Trial
The RESTORE (BTK) below the knee study is a prospective, non- randomized, multi-center study for treatment of stenotic lesions with the Bolt Intravascular Lithotripsy System.
- Trial name
- NCT05535907
- Testing
- Intravascular Lithotripsy
- Where
- 4 sites in Austria, Croatia and 2 more
- Volunteers
- 20 people
- Sponsor
- Bolt Medical
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities
SELUTION4BTK Trial
This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in…
- Trial name
- NCT05055297
- Testing
- SELUTION SLR™ DEB 014, Plain (Uncoated) Balloon Angioplasty (PTA)
- Where
- 48 sites in United States, Austria and 8 more
- Volunteers
- 376 people
- Sponsor
- M.A. Med Alliance S.A.
Peripheral Arterial Occlusive Disease
Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral DSA
The purpose of this study is to compare ISOVUE-250 and VISIPAQUE 270 for motion artifact and pain following intraarterial injection for peripheral DSA.
- Trial name
- NCT00740207
- Testing
- VISIPAQUE 270, Isovue 250
- Volunteers
- 33 people
- Sponsor
- Bracco Diagnostics, Inc
Peripheral Vascular Disease, Peripheral Arterial Disease
EVERO Drug-coated Balloon (DCB) Randomized Trial
The primary objective of the study is to evaluate the long-term safety and effectiveness of the Advance Evero™ 18 Everolimus-coated Percutaneous Transluminal Angioplasty Balloon Catheter (hereafter referred to as the Evero…
- Trial name
- NCT07144150
- Testing
- Evero DCB, Paclitaxel DCB
- Where
- 12 sites in United States
- Volunteers
- 410 people
- Sponsor
- Cook Research Incorporated
Critical Limb Ischemia
Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.
- Trial name
- ILLUMENATE-BTK (NCT03175744)
- Testing
- Stellarex DCB, PTA Catheter
- Where
- 21 sites in United States, Australia and 3 more
- Volunteers
- 82 people
- Sponsor
- Spectranetics Corporation
Critical Limb Ischemia
Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT
Using gene therapy to express active telomerase (hTERT) in human cells has the potential to treat many diseases related to aging, including critical limb ischemia (CLI).
- Trial name
- NCT04110964
- Testing
- AAV-hTERT
- Where
- Colombia
- Volunteers
- 5 people
- Sponsor
- Libella Gene Therapeutics
Peripheral Arterial Disease, Claudication
ILLUMENATE EU Randomized Clinical Trial
This is a prospective, randomized, multi-center, single-blind study to demonstrate the safety and effectiveness of the CVI Paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon versus bare PTA balloon for the…
- Trial name
- EU RCT (NCT01858363)
- Testing
- CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter, Bare Percutaneous Transluminal Angioplasty Balloon Catheter
- Where
- Germany
- Volunteers
- 294 people
- Sponsor
- Spectranetics Corporation
Critical Limb Ischemia (CLI)
IBS Titan vs. PTA in Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease
A prospective, multi-center, randomized trial to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with infrapopliteal arterial stenosis or…
- Trial name
- GENIUS (NCT04849325)
- Testing
- Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™), Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 29 sites in China
- Volunteers
- 120 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
Peripheral Artery Disease (PAD), Dysfunctional AV Fistula
Serranator POINT FORCE Registry
The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® in treatment of peripheral artery disease (PAD), or dysfunctional native or…
- Conditions
- Peripheral Artery Disease (PAD), Dysfunctional AV Fistula, Dysfunctional AV Graft
- Trial name
- POINT FORCE (NCT06687590)
- Testing
- Peripheral balloon angioplasty
- Where
- 19 sites in United States
- Volunteers
- 500 people
- Sponsor
- Cagent Vascular LLC
Peripheral Arterial Disease, Peripheral Vascular Diseases
ACHIEVE GRX Registry
This study will evaluate real-world performance of the CorPath GRX System in peripheral vascular interventions.
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Renal Artery Disease, Carotid Artery Diseases
- Trial name
- NCT04513613
- Testing
- Procedure/Surgery: Robotic-PVI
- Sponsor
- Siemens Healthineers Endovascular Robotics, Inc.
Peripheral Arterial Disease
MIMICS-3D-USA Registry Study
The MIMICS-3D-USA Study is a prospective, multicentre, observational study (non-investigational) of the BioMimics 3D Vascular Stent System that evaluates evaluate safety, effectiveness and device performance within a real-world…
- Trial name
- NCT04640597
- Testing
- BioMimics 3D Vascular Stent System
- Where
- 27 sites in United States
- Volunteers
- 500 people
- Sponsor
- Veryan Medical Ltd.
Peripheral Arterial Disease
CVI Drug Coated Balloon First In Human Trial
The purpose of this study is to assess safety and the inhibition of restenosis of the CVI Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or reoccluded/restenotic superficial femoral (SFA) or…
- Trial name
- NCT02110524
- Testing
- Percutaneous Transluminal Angioplasty
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Spectranetics Corporation
Peripheral Arterial Disease
A Clinical Study on Efficacy & Safety Profile of Propionyl-L-carnitine Tablets for Peripheral Arterial Diseases
The main objective of this study is to evaluate the effectiveness and safety of the propionyl-L-carnitine hydrochloride tablets among Chinese population in comparison with the placebo, for treatment of the peripheral arterial…
- Trial name
- PLC (NCT00809497)
- Testing
- Propionyl-L-carnitine Tablets
- Where
- China
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Lee's Pharmaceutical Limited
Peripheral Artery Disease
Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System
To assess the continued safety, effectiveness, and optimal clinical use of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic BTK arteries.
- Trial name
- NCT05007925
- Testing
- Intravascular Lithotripsy
- Where
- 43 sites in United States, Germany
- Volunteers
- 250 people
- Sponsor
- Shockwave Medical, Inc.
Peripheral Arterial Disease
STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)
Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of the Stellarex 035 Drug Coated Balloon (formerly known as the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter) in…
- Trial name
- ILLUMENATE (NCT01927068)
- Testing
- Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB)
- Where
- 44 sites in Australia, Austria and 8 more
- Volunteers
- 499 people
- Sponsor
- Spectranetics Corporation
Peripheral Artery Disease
The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions
The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in peripheral vasculature.
- Trial name
- NCT00676494
- Testing
- Pathway PV Atherectomy System
- Volunteers
- 172 people
- Sponsor
- Pathway Medical Technologies Inc.