Clinical trials: Peripheral Vascular Diseases
Vascular Diseases, Peripheral
FLUENCY® PLUS in the Treatment of Peripheral Artery Disease
This is a retrospective, multi-center study to assess the safety and performance by proactively reviewing pre-existing medical records and imaging of patients who had previous placement of FLUENCY® PLUS Vascular Stent Graft in…
- Trial name
- NCT04765566
- Testing
- Endovascular revascularization of peripheral arteries
- Where
- 6 sites in Germany, Poland
- Volunteers
- 146 people
- Sponsor
- C. R. Bard
Central Nervous System (CNS) Lesions, Brain Metastases
Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent
This Phase 2 clinical trial will study RVP-001, a new manganese-based MRI contrast agent, in people who are known to have gadolinium-enhancing central nervous system (CNS) lesions, for example brain tumors or multiple sclerosis.
- Conditions
- Central Nervous System (CNS) Lesions, Brain Metastases, Brain Neoplasms, Brain Neoplasms, Benign
- Trial name
- NCT06322342
- Testing
- RVP-001
- Where
- 5 sites in United States
- Volunteers
- 18 people
- Sponsor
- Reveal Pharmaceuticals Inc.
Peripheral Arterial Disease, Peripheral Vascular Diseases
Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter
The objective of this patient registry is to assess the clinical use of the Lutonix 035 DCB PTA Catheter in a heterogeneous patient population in a real world and on-label clinical application.
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Arterial Occlusive Diseases
- Trial name
- SAFE-DCB (NCT02424383)
- Testing
- PTA (Lutonix® 035 DCB Catheter)
- Where
- 73 sites in United States
- Volunteers
- 1,005 people
- Sponsor
- C. R. Bard
Critical Limb Ischemia
Mesenchymal Stem Cells in Critical Limb Ischemia
This clinical trial aims to study the safety and efficacy of adult mesenchymal stem cells in critical limb ischemia.
- Trial name
- NCT00883870
- Testing
- mesenchymal stem cells, Plasmalyte A
- Where
- 4 sites in India
- Volunteers
- 20 people
- Sponsor
- Stempeutics Research Pvt Ltd
Arterial Disease of Legs, Below-the-knee Obstruction
Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
This is a Pivotal, Prospective, randomized, two arm, placebo controlled, single-blind, multicenter trial that will be conducted at approximately 80 sites; approx.
- Conditions
- Arterial Disease of Legs, Below-the-knee Obstruction, PAD - Peripheral Arterial Disease
- Trial name
- MAGICAL BTK (NCT06182397)
- Testing
- MagicTouch PTA Sirolimus drug coated balloon
- Where
- 29 sites in United States
- Volunteers
- 368 people
- Sponsor
- Concept Medical Inc.
Peripheral Arterial Disease
Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access
The primary objective of this clinical investigation was to evaluate acute safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System, when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon…
- Trial name
- RADIANCY (NCT05399680)
- Testing
- S.M.A.R.T. RADIANZ™ Vascular Stent System, BRITE TIP RADIANZ™ Guiding Sheath, SABERX RADIANZ™ PTA Balloon Catheter
- Where
- 12 sites in Austria, Belgium and 4 more
- Volunteers
- 151 people
- Sponsor
- Cordis US Corp.
Peripheral Artery Disease
Pharmacokinetic Study of Drug-coated Angioplasty Balloons in the Superficial Femoral or Popliteal Arteries:
To describe the pharmacokinetics of paclitaxel in the blood delivered from a paclitaxel coated percutaneous angioplasty balloon catheter as a result of treatment of de novo or restenotic lesion(s), occluded/stenotic or…
- Trial name
- PK (NCT01912937)
- Testing
- Angioplasty treatment with the CVI Drug-coated Balloon (DCB)
- Where
- 2 sites in New Zealand
- Volunteers
- 25 people
- Sponsor
- Spectranetics Corporation
Peripheral Artery Disease
Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy
This is a prospective, single-arm, multi-center study designed to evaluate the safety and efficacy of the Orbital Atherectomy System (OAS) for the treatment of adult Japanese subjects with a de novo symptomatic calcified…
- Trial name
- KAIZEN (NCT05529472)
- Testing
- Peripheral Orbital Atherectomy System (OAS)
- Where
- 12 sites in Japan
- Volunteers
- 81 people
- Sponsor
- Abbott Medical Devices
Peripheral Vascular Disease
The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study
The objective of this study is to evaluate the safety and efficacy of the Assurant Cobalt Iliac Stent System in the treatment of de novo and restenotic lesions in iliac arteries of subjects with Peripheral Artery Disease (PAD).
- Trial name
- ACTIVE (NCT00753337)
- Testing
- Assurant® Cobalt Iliac Stent System
- Where
- 2 sites in United States
- Volunteers
- 123 people
- Sponsor
- Medtronic Endovascular
Critical Limb Ischemia
MOTIV BTK Randomized Controlled Trial
Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions.
- Trial name
- NCT05406622
- Testing
- MOTIV Sirolimus-Eluting Bioresorbable Scaffold, Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 26 sites in United States, Germany
- Volunteers
- 292 people
- Sponsor
- REVA Medical, Inc.
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.
Peripheral Arterial Disease, Critical Limb Ischemia
Serranator Recoil Study
The study objective is to assess the ability to define and measure post treatment recoil in infrapopliteal arteries. Preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as…
- Trial name
- NCT05161039
- Testing
- Serranator, POBA
- Where
- 2 sites in United States, Germany
- Volunteers
- 20 people
- Sponsor
- Cagent Vascular LLC
Peripheral Arterial Disease (PAD)
Zilver Flex Post-Market Study in Japan
Japanese post market clinical study of the Zilver Flex device.
- Trial name
- NCT02254356
- Testing
- Zilver Flex Bare Metal Stent
- Where
- Japan
- Volunteers
- 239 people
- Sponsor
- Cook Group Incorporated
Peripheral Arterial Disease
BEnefit of Arterial Preparation by LONGitudinal Scoring
The purpose of the artery preparation concept is to perform regular longitudinal micro-incisions on the inner side of the artery ("scoring") and therefore promote a regular expansion of atheroma by balloon inflation.
- Trial name
- BELONG (NCT03721939)
- Testing
- FLEX Scoring Catheter
- Where
- Switzerland
- Volunteers
- 150 people
- Sponsor
- VentureMed Group Inc.
Peripheral Arterial Disease
The Cre8™ BTK Post Market Clinical Follow-up Study
Cre8™ BTK is a CE marked drug eluting stent, integrally coated with i-Carbofilm, loaded with formulated Sirolimus for the treatment of infrapopliteal peripheral artery disease.
- Trial name
- NCT05616156
- Testing
- Cre8™ BTK
- Where
- 2 sites in Italy
- Volunteers
- 30 people
- Sponsor
- CID S.p.A.
Peripheral Artery Disease
Alprostadil Liposomes for Injection for Lower Extremity Arteriosclerosis Obliteran
This is a randomized, positive-control, multicenter, multiple-dose, dose-escalation phase II trial
- Trial name
- NCT04197323
- Testing
- Alprostadil liposomes for injection
- Where
- China
- Volunteers
- 20 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Peripheral Arterial Disease
Investigational Study of SWM-831 to Treat Moderate and Severely Calcified Femoropopliteal Arteries
Disrupt PAD Japan is a prospective, multi-center, single-arm study of SWM-831 to treat moderate and severely calcified femoropopliteal arteries, prior to DCB or stenting.
- Trial name
- NCT06938854
- Testing
- Peripheral Intravascular Lithotripsy (IVL)
- Where
- 10 sites in Japan
- Volunteers
- 81 people
- Sponsor
- Shockwave Medical, Inc.
Peripheral Arterial Disease, Calcifications Vascular
SOLUTION Trial in China
This is a prospective, multicenter, single arm study, to support the safety and effectiveness assessment of the Shockwave Medical Peripheral IVL System applied to Chinese patients
- Trial name
- NCT05434676
- Testing
- Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 & S4
- Where
- 5 sites in China
- Volunteers
- 20 people
- Sponsor
- Genesis Medtech Corporation
Peripheral Artery Disease
Clinical Study of Focal Implant Used for Lower Extremity Post-angioplasty Dissection
This is a prospective, multicenter, randomized controlled trail using spot stenting to treat lower extremity post-angioplasty dissection.
- Trial name
- PINTO (NCT05562076)
- Testing
- the spot stent(ZENFLEX ® Pinto) system, the bare stent( Everflex) system
- Where
- 12 sites in China
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Peripheral Artery Disease
Lutonix Global SFA Registry
The registry will enroll patients with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery.
- Trial name
- NCT01864278
- Testing
- Lutonix Drug Coated Balloon
- Where
- 23 sites in Austria, Belgium and 8 more
- Volunteers
- 691 people
- Sponsor
- C. R. Bard