Clinical trials: Peripheral Revascularisation
Critical Limb Ischemia, Peripheral Arterial Disease
Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia for Peripheral Revascularization
The objective Study is to evaluate the short- and long-term clinical outcomes of patients receiving the CryoVein cryopreserved saphenous vein allograft (CVA) as their primary open bypass conduit to assess if there is a…
- Trial name
- LIMBSAVE (NCT01799811)
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- CryoLife, Inc.
Iliac Artery Stenosis
Misago® RX Self-expanding Peripheral Stent for Common and/or External Iliac Artery
This is a multi-center, single arm, non-randomized, prospective clinical study using the Misago® RX Self-expanding Peripheral Stent for treatment of de novo, restenotic, and/or occlusive lesion(s) of the common and/or external…
- Trial name
- OSPREY ILIAC (NCT02793492)
- Testing
- Misago® RX Self-expanding Peripheral Stent
- Where
- 9 sites in United States
- Volunteers
- 75 people
- Sponsor
- Terumo Medical Corporation
Peripheral Vascular Disease
Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease (PAD); This trial is designed to assess the efficacy and safety of the…
- Trial name
- NCT00059657
- Testing
- Ecraprost in lipid emulsion
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 280 people
- Sponsor
- Tanabe Pharma Corporation
Peripheral Artery Disease
Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities
The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the…
- Trial name
- VOYAGER PAD (NCT02504216)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 532 sites in United States, Argentina and 32 more
- Volunteers
- 6,564 people
- Sponsor
- Bayer
Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM)
The Efficacy and Safety of REX-001 to Treat Ischemic Rest Pain in Subjects With CLI Rutherford Category 4 and DM
This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 4.
- Conditions
- Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM), Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT03111238
- Testing
- REX-001
- Where
- 15 sites in Czechia, Germany and 4 more
- Volunteers
- 3 people
- Sponsor
- Ixaka Ltd
Critical Limb Ischemia (CLI)
Expanded Access Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
A Phase III study of PLX-PAD for CLI patients with minor tissue loss who are unsuitable for revascularization has been initiated (PLX-CLI-03, PACE study).
- Trial name
- NCT03886506
- Testing
- PLX-PAD
- Where
- 2 sites in United States
- Sponsor
- Pluristem Ltd.
Iliac Artery Stenosis
Evaluation of the Efficacy and Safety of the Application of BeGraft Peripheral Stent Graft System
The trial will be conducted to evaluate the safety and efficacy of the BeGraft Peripheral Stent Graft System in interventional revascularisation for subjects with primary iliac artery stenosis and/or occlusive lesions by…
- Trial name
- NCT04023370
- Testing
- Treatment of primary iliac artery stenosis and/or occlusive lesions
- Where
- 12 sites in China
- Volunteers
- 182 people
- Sponsor
- Bentley InnoMed GmbH
Peripheral Artery Disease
Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization
To evaluate the safety and effectiveness of the Revolution™ Peripheral Atherectomy System in the treatment of infrainguinal lower extremity peripheral arterial occlusive disease.
- Trial name
- REVEAL (NCT02961894)
- Testing
- Revolution™ Peripheral Atherectomy System
- Where
- 17 sites in United States
- Volunteers
- 121 people
- Sponsor
- Rex Medical
Peripheral Arterial Disease
SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease
To investigate the efficacy of the administration of JVS-100 delivered via direct intramuscular injections on a 3 month and 6 month composite endpoint of wound progression, healing and limb loss in patients with severe peripheral…
- Trial name
- STOP-PAD (NCT02544204)
- Testing
- JVS-100
- Where
- 24 sites in United States
- Volunteers
- 120 people
- Sponsor
- Juventas Therapeutics, Inc.
Peripheral Arterial Diseases
Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease
To assess the safety and effectiveness of adventitial deposition of the Study Drug in reducing inflammation and restenosis in patients with clinical evidence of claudication or critical limb ischemia and an angiographically…
- Trial name
- DANCE (NCT01983449)
- Testing
- Dexamethasone Sodium Phosphate Injection, USP
- Where
- 38 sites in United States
- Volunteers
- 285 people
- Sponsor
- Mercator MedSystems, Inc.
Arterial Occlusive Diseases
Crossing Atheroma or Thrombus With ByCross Device for Revascularization of Peripheral Arteries of Diameter ≥ 3mm
The aim of the study is to demonstrate safety and effectiveness of ByCross Rotational and Aspiration device used for revascularization of total or sub-total occluded peripheral arterial vessels equal to or larger than 3mm in…
- Trial name
- NCT03724279
- Testing
- ByCross Atherectomy and Thrombectomy
- Where
- 2 sites in Germany
- Volunteers
- 42 people
- Sponsor
- Taryag Medical Ltd.
Critical Limb Ischemia, Peripheral Arterial Disease
Revascularization of Stenosed Vessels Using Optimized Treatment of Rejuveinix for Reversing Endothelial Dysfunction
A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of Rejuveinix in Combination With Standard Interventional Therapy for Critical Limb Ischemia Patients with Rutherford Class 4, 5 and 6 Disease
- Trial name
- RESTORE (NCT03041259)
- Testing
- Rejuveinix Low Dose, Rejuveinix High Dose
- Volunteers
- 320 people
- Sponsor
- Reven Pharmaceuticals, Inc.
Critical Limb Ischemia
Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia
A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.
- Trial name
- NCT02046226
- Testing
- Oxygenesys(TM) Dissolved Oxygen Dressing
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Halyard Health
Peripheral Arterial Disease, Peripheral Vascular Disease
Clinical Pilot-Study of ProEndoTecc Vascular Grafts as Superficial Femoral Artery Bypass / Interponate
This is a multi-center, clinical pilot-study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm Diameter) as superficial femoral artery bypass/interponate.
- Trial name
- NCT01095237
- Testing
- ProEndoTecc Vascular Graft
- Where
- 12 sites in Germany
- Volunteers
- 33 people
- Sponsor
- NonWoTecc Medical GmbH
Peripheral Artery Disease
Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen
The objective of this first-in-human study is to assess the safety and effectiveness of the Serranator Sonic Intravascular Lithotripsy (IVL) System™ for the treatment of peripheral artery disease.
- Trial name
- REMODEL I (NCT07575568)
- Testing
- Serranator Sonic Intravascular Lithotripsy (IVL) System
- Volunteers
- 30 people
- Sponsor
- Cagent Vascular LLC
Peripheral Artery Disease (PAD)
Walking Effect of Long Term Ticagrelor in Subjects With PAD Who Have Undergone EVR
To compare the effect of ticagrelor versus aspirin on the change in peak walking time, evaluated on the graded treadmill test, from one to 26 weeks post-revascularization in patients with peripheral artery disease who have…
- Trial name
- TI-PAD EVR (NCT02227368)
- Testing
- Ticagrelor, Comparator
- Where
- 10 sites in United States
- Volunteers
- 40 people
- Sponsor
- AstraZeneca
Critical Limb Ischemia
An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)
This study is designed to evaluate the efficacy and safety of ixmyelocel-T, a patient-specific expanded multicellular therapy, for the treatment of patients with critical limb ischemia (CLI).
- Trial name
- REVIVE (NCT01483898)
- Testing
- Ixmyelocel-T
- Where
- 86 sites in United States
- Volunteers
- 41 people
- Sponsor
- Vericel Corporation
Critical Limb Ischemia (CLI)
Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
This will be a randomized, placebo-controlled, parallel group, multicenter, Phase III study.The study aims to evaluate the Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects…
- Trial name
- NCT03006770
- Testing
- PLX-PAD
- Where
- 57 sites in United States, Bulgaria and 7 more
- Volunteers
- 213 people
- Sponsor
- Pluristem Ltd.
Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM)
The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM
This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 5.
- Conditions
- Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM), Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT03174522
- Testing
- REX-001
- Where
- 15 sites in Czechia, Hungary and 4 more
- Volunteers
- 49 people
- Sponsor
- Ixaka Ltd
Atherosclerosis, Arteriosclerosis
BIOLUX P-II First-in-Man Study to Compare the Passeo-18 Lux DRB Against POBA in Infrapopliteal Arteries
A prospective, multicentric, randomized controlled trial to assess the safety and performance of the Passeo-18 Lux Paclitaxel releasing PTA balloon catheter versus the uncoated Passeo 18 PTA balloon catheter for the treatment of…
- Conditions
- Atherosclerosis, Arteriosclerosis, Vascular Disease, Peripheral Artery Disease
- Trial name
- BIOLUX P-II (NCT01867736)
- Testing
- Passeo-18 Lux DRB, Standard PTA (POBA)
- Where
- 6 sites in Austria, Belgium and 1 more
- Volunteers
- 72 people
- Sponsor
- Biotronik AG