Clinical trials: Peripheral Artery Disease
Critical Limb Ischemia, Chronic Limb-Threatening Ischemia
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.
- Conditions
- Critical Limb Ischemia, Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
- Trial name
- NCT05313165
- Testing
- LimFlow Stent Graft System
- Where
- 30 sites in United States
- Volunteers
- 100 people
- Sponsor
- LimFlow, Inc.
Peripheral Arterial Disease, Peripheral Vascular Diseases
Safety and Feasibility of SurModics SurVeil (TM) Drug Coated Balloon
PREVEIL is a prospective, multi-center, single-arm clinical trial to assess the safety and functionality of the SurModics drug coated balloon (DCB) in the treatment of subjects with symptomatic peripheral artery disease (PAD) due…
- Trial name
- PREVEIL (NCT02648620)
- Testing
- SurVeil Drug Coated Balloon, Angioplasty
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- SurModics, Inc.
Patients With Symptomatic Critical Limb Ischemia, Severe Intermittent Claudication
Self Expanding Nitinol Stent Versus Percutaneous Transluminal Arterial Angioplasty (PTA) With Optional Bailout Stenting in Case of PTA Failure in Patients With Symptomatic Critical Limb Ischemia or Severe Intermittent Claudication (EXPAND)
The clinical investigation is a prospective, international, multi-centre, randomized (1:1) trial with follow up investigations at 1, 3, 6 and 12 months.
- Trial name
- EXPAND (NCT00906022)
- Testing
- Astron Pulsar Stent, PTA alone
- Where
- Germany
- Volunteers
- 94 people
- Sponsor
- Biotronik AG
Peripheral Arterial Disease (PAD)
Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease
Primary objective: To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interests in patients with peripheral arterial disease (PAD) Secondary objectives: To…
- Trial name
- NCT00862420
- Testing
- clopidogrel (SR25990), ticlopidine
- Where
- Japan
- Volunteers
- 431 people
- Sponsor
- Sanofi
Peripheral Arterial Disease, Peripheral Artery Disease
Tissue Monitoring During Endovascular Intervention
Tissue perfusion assessment is key to more accurate measurement of foot ischemia, which is in turn an important factor in appropriate treatment decisions.
- Conditions
- Peripheral Arterial Disease, Peripheral Artery Disease, Arterial Occlusive Diseases
- Trial name
- TIME (NCT04744870)
- Volunteers
- 80 people
- Sponsor
- Pedra Technology, PTE LTD
Peripheral Arterial Occlusive Disease
GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft
The primary patency of the GORE PROPATEN Vascular Graft is equivalent to or better than disadvantaged autologous vein graft in an infragenicular peripheral bypass application at 12 months.
- Trial name
- PRODIGY (NCT00617279)
- Testing
- GORE PROPATEN Vascular Graft, Disadvantaged Autologous Vein Graft
- Where
- 17 sites in United States
- Volunteers
- 31 people
- Sponsor
- W.L.Gore & Associates
Peripheral Artery Disease
BRight DCB First-in-Human Study
The primary aim of this clinical study is to assess the safety and clinical performance of the BRight drug-coated balloon (DCB) in the treatment of lower limb arteries stenosis in subjects with Peripheral Artery Disease (PAD).
- Trial name
- NCT04525794
- Testing
- BRight DCB
- Where
- 7 sites in Australia, Austria and 2 more
- Volunteers
- 48 people
- Sponsor
- Biotronik CRC Inc.
Peripheral Artery Disease
Acotec DCB Post Market Clinical Follow-up
All-comers, prospective, multi-center, single-arm, non-interventional post market clinical follow-up (PMCF) Cohort 1 - Claudicants: Rutherford Clinical Category (RCC) 2-3 Cohort 2 - Critical Limb Ischemia: Rutherford Clinical…
- Trial name
- FLOWER (NCT04393389)
- Testing
- AcoArt Orchid (0.035"), AcoArt Tulip (0.018") and AcoArt Litos (0.014") percutaneous transluminal angioplasty (PTA) paclitaxel drug coated balloon catheter manufactured by Acotec Scientific Co., Ltd.
- Where
- 7 sites in Germany
- Volunteers
- 3,000 people
- Sponsor
- Acotec Scientific Co., Ltd
Stenosis of Artery, Peripheral Arterial Disease
The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
This is a prospective, single-center, non-randomized phase 2, first-in-iliac artery study, to evaluate the safety and effectiveness of the WRAPSODY Stent Graft for the treatment of peripheral arterial occlusive disease in…
- Conditions
- Stenosis of Artery, Peripheral Arterial Disease, Iliac Artery Disease, Iliac Artery Occlusion
- Trial name
- NCT03994185
- Testing
- Placement of WRAPSODY stent graft
- Sponsor
- Merit Medical Systems, Inc.
Peripheral Arterial Disease
Comparison of Lower Limb Endovascular Interventions With and Without the EndoNaut Workstation
To demonstrate that the use of EndoNaut for endovascular procedures on the femoropopliteal axis has a clinical impact for the patient (decrease in irradiation and the volume of contrast product) as well as for nursing staff…
- Trial name
- COMPAR-MI (NCT04709991)
- Testing
- Endovascular procedure
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Therenva
Peripheral Arterial Disease
Safety and Performance Study of the Shockwave Lithoplasty System
To study the safety and performance of the Shockwave Medical Lithoplasty System in subjects to demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of…
- Trial name
- DISRUPT-PAD (NCT02071108)
- Testing
- Shockwave Lithoplasty System
- Where
- 3 sites in Austria, Germany and 1 more
- Volunteers
- 35 people
- Sponsor
- Shockwave Medical, Inc.
Vascular Closure, Endovascular Procedure
Post-market Clinical Investigation of the Angio-Seal™ VIP VCD (ANGIO-SEAL CLOSE)
The present post-market surveillance study aims to evaluate the safety and effectiveness of the Angio-SealTM VIP VCD in patients undergoing endovascular procedures via femoral access in real-world setting.
- Conditions
- Vascular Closure, Endovascular Procedure, Hemostasis, Peripheral Vascular Disease
- Trial name
- NCT05335525
- Testing
- Closure of the femoral arterial puncture site
- Where
- 4 sites in France, Germany and 1 more
- Volunteers
- 230 people
- Sponsor
- Terumo Europe N.V.
Peripheral Artery Disease
Monitoring Local Tissue Oxygen Changes Using the Wireless Lumee Oxygen Platform in Correlation to TcPO2
The purpose of this study is to monitor changes in local tissue oxygen levels in participants with Peripheral Artery Disease (PAD) using the Wireless Lumee Oxygen Platform.
- Trial name
- NCT04514861
- Testing
- Wireless Lumee Oxygen Platform
- Where
- 3 sites in United States
- Volunteers
- 53 people
- Sponsor
- Profusa, Inc.
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.
Ischemia
Study of Autologous Bone Marrow Concentrate for the Treatment of Critical Limb Ischemia (CLI)
Injections of concentrated bone marrow mononuclear cells into ischemic tissues will result in vasculogenesis
- Trial name
- NCT00498069
- Testing
- Harvest Smartprep2 BMAC System, SmartPReP2 BMAC System
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Harvest Technologies
Arterial Occlusive Diseases
Feasability Study of Autologous Bone Marrow Aspirate Concentrate for Treatment of CLI
The purpose of this study is to determine if concentrated nucleated cells from your own bone marrow, injected or infused into an ischemic limb, will restore sufficient blood flow to avoid amputation.
- Trial name
- NCT00595257
- Testing
- centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Harvest Technologies
Peripheral Vascular Diseases
Efficacy and Safety of XRP0038/NV1FGF in Critical Limb Ischemia Patients With Skin Lesions
Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes…
- Trial name
- TAMARIS (NCT00566657)
- Testing
- riferminogene pecaplasmid
- Where
- 32 sites in United States, Argentina and 30 more
- Volunteers
- 525 people
- Sponsor
- Sanofi
Critical Limb Ischemia, Peripheral Arterial Disease
Pilot Safety Study of Injectable SIS for Critical Limb Ischemia
This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- CLIC (NCT02145845)
- Testing
- Injectable SIS
- Where
- Czechia
- Volunteers
- 13 people
- Sponsor
- Cook Group Incorporated
Intermittent Claudication
Safety and Efficacy of K-134 for the Treatment of Intermittent Claudication
The purpose of this study is to evaluate the safety and efficacy of K-134 for the treatment of intermittent claudication.
- Trial name
- NCT00783081
- Testing
- K-134, Cilostazol 100 mg BID
- Where
- 42 sites in United States, Russia
- Volunteers
- 387 people
- Sponsor
- Kowa Research Institute, Inc.
Intermittent Claudication, Peripheral Vascular Disease
The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC
The purpose of this study is to compare the dose response and safety of Niacin ER/Lovastatin, Niaspan® and Lovastatin with each other, in subjects with leg pain caused by a narrowing of their leg arteries.
- Trial name
- NCT00071266
- Testing
- Niacin Extended Release and Lovastatin Tablets
- Where
- 26 sites in United States
- Volunteers
- 870 people
- Sponsor
- Kos Pharmaceuticals