Clinical trials: Artery Disease, Peripheral
Peripheral Arterial Disease
DEFINITIVE AR Two Year Follow-up Extension Study
The purpose of this DEFINITIVE AR Two Year Follow-up Extension Study is to gather data to assess and estimate the long term effect of treating a vessel with plaque excision (PE) in combination with paclitaxel-coated balloon…
- Trial name
- NCT02363894
- Volunteers
- 53 people
- Sponsor
- Medtronic Endovascular
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
Arterial Occlusive Disease, Intermittent Claudication
Safety and Efficacy of Express LD to Treat Stenosed or Occlusive Atherosclerotic Disease in Iliac Arteries
To obtain additional data on safety and efficacy of the Express stent implantation in the treatment of stenosed or occlusive atherosclerotic disease (de novo or restenotic lesions) in the iliac arteries (common or external).
- Conditions
- Arterial Occlusive Disease, Intermittent Claudication, Atherosclerotic Disease, Thrombosis
- Trial name
- MELODIE (NCT00352222)
- Testing
- stent implantation
- Where
- 10 sites in Belgium, Canada and 3 more
- Volunteers
- 150 people
- Sponsor
- Boston Scientific Corporation
Peripheral Artery Disease
REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study
This is an observational study of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease.
- Trial name
- RESULTS (NCT04010045)
- Testing
- Endovascular Treatment of PAD
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Ra Medical Systems
Peripheral Arterial Disease, Iliac Artery Disease
Endovascular Treatment of Peripheral Artery Disease
The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635) or balloon angioplasty (Cardionovum Legflow or Optimed Nylotrack .035 + .018)…
- Conditions
- Peripheral Arterial Disease, Iliac Artery Disease, Below-the-knee Obstruction, Femoropopliteal Occlusive Disease
- Trial name
- PAD (NCT03346577)
- Testing
- stent or balloon
- Where
- Belgium
- Volunteers
- 60 people
- Sponsor
- be Medical
Peripheral (Lowr Extremity) Arterial Disease.
Rapid Exchange Devices Observational Registry.
This registry is designed to assess the clinically relevant benefits of balloon angioplasty and stenting in superficial femoral and popliteal artery, using rapid exchange technology.
- Trial name
- RXRegistry (NCT01994798)
- Where
- 9 sites in Belgium, Spain
- Volunteers
- 525 people
- Sponsor
- Terumo Europe N.V.
Foot Ulcers, Diabetic
Efficacy of Plasma Rich in Growth Factors (PRGF) in the Treatment of Foot Ulcers in Diabetic Patients With Peripheral Arterial Disease
This study is a randomized clinical trial that compares the effectiveness of Plasma Rich in Growth Factors (PRGF) with conventional treatment for healing foot ulcers in diabetic patients who also have peripheral arterial disease.
- Trial name
- PIEDIABETICO (NCT06952998)
- Testing
- Topical application of Plasma Rich in Growth Factors (PRGF), Conventional treatment (conventional treatment with adequate offloading and metabolic control, +/- antibiotic).
- Where
- Spain
- Volunteers
- 38 people
- Sponsor
- Biotechnology Institute IMASD
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, Peripheral Arterial Disease(PAD)
Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries (BIO-OSCAR First)
The purpose of this study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications for endovascular peripheral interventions of femoral, popliteal and infrapopliteal lesions.
- Trial name
- NCT06758921
- Testing
- Oscar Peripheral Multifunctional Catheter
- Where
- 16 sites in Austria, Belgium and 6 more
- Volunteers
- 200 people
- Sponsor
- Biotronik AG
Peripheral Arterial Disease
Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization
This is a prospective, multi-center, pilot feasibility study to document the effects of adventitial delivery of temsirolimus or temsirolimus with dexamethasone sodium phosphate injection, USP, after revascularization of…
- Trial name
- TAP-DANCE (NCT03942601)
- Testing
- Temsirolimus, Temsirolimus and dexamethasone sodium phosphate
- Where
- 11 sites in United States
- Volunteers
- 10 people
- Sponsor
- Mercator MedSystems, Inc.
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 Arterial Disease
Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia
Near-infrared spectroscopy can be used to determine the relative oxygen saturation in tissues up to 2cm below the skin. It has been investigated, with success, in cerebral, gastrointestinal, and muscle tissue, and shows promise…
- Trial name
- NCT00224328
- Testing
- ODISsey Tissue Oximeter
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- ViOptix Canada
Chronic Limb-Threatening Ischemia
AcoArt Litos PCB Below-the-knee Global Trial
The objective of this study is to assess whether efficacy of the AcoArt Litos PCB is superior and whether safety of AcoArt Litos PCB is noninferior to the control device (FDA cleared PTA Balloon Catheter) regarding treatment of…
- Trial name
- NCT06330493
- Testing
- PCB, PTA
- Where
- 18 sites in United States, Austria and 1 more
- Volunteers
- 75 people
- Sponsor
- Acotec Scientific Co., Ltd
Hyperlipidemias, Atherosclerosis
Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets
A cholesterol/lipid profile screening project of high risk patients with hyperlipidaemia (secondary prevention) who already receive cholesterol-lowering therapy.
- Conditions
- Hyperlipidemias, Atherosclerosis, Coronary Heart Disease, Carotid Stenosis
- Trial name
- NCT00536796
- Where
- Austria
- Volunteers
- 1,096 people
- Sponsor
- AstraZeneca
Peripheral Arterial Disease
Pantheris Atherectomy Treatment of In-Stent Restenosis In Lower Extremity Arteries
A prospective, non-randomized, international, multi-center study to evaluate the safety and effectiveness of the Pantheris OCT-Imaging System to perform atherectomy in In-Stent Restenotic (ISR) lesions in lower extremity arteries.
- Trial name
- INSIGHT (NCT03192696)
- Testing
- Atherectomy Catheter
- Where
- 12 sites in United States
- Volunteers
- 127 people
- Sponsor
- Avinger, Inc.
Symptomatic Vascular Disease of the Iliac Arteries
FORMAT Clinical Study
The FORMAT Clinical Study is a clinical trial to evaluate the safety and effectiveness of the Formula™ 535 Iliac Balloon-Expandable Stent in treatment of symptomatic vascular disease of the iliac arteries.
- Trial name
- NCT01804088
- Testing
- Formula™ 535 Iliac Balloon-Expandable Stent
- Where
- 12 sites in United States
- Volunteers
- 80 people
- Sponsor
- Cook Group Incorporated
Amputation Wound, Peripheral Arterial Disease
Wound Imaging Study to Gather Clinical References for a Device to Assist Selecting Level-of-amputation in PAD Patients
This is a proof-of-concept study to collect images to train a CADe algorithm to predict the correct level of amputation in individuals scheduled for amputation secondary to PAD.
- Trial name
- WISCR (NCT03611361)
- Testing
- SpectralMD DeepView Wound Imaging System 2.0
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- SpectralMD
Peripheral Arterial Disease
Evaluate the Efficacy and Safety of the Cilostazol-coated BioMimics 3D Stent System in Patients with Peripheral Arterial Occlusive Disease
An exploratory evaluation of the efficacy and safety of CLZ-BM3D for the treatment of symptomatic peripheral occlusive arterial disease of the superficial femoral artery or proximal popliteal artery
- Trial name
- NCT05759819
- Testing
- Standard stenting
- Where
- 5 sites in Japan
- Volunteers
- 24 people
- Sponsor
- Otsuka Medical Devices Co., Ltd. Japan
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
A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries.
Evaluation of the Gore(R) VIABAHN BX for the treatment of arterial occlusive disease in the common and/or external iliac arteries.
- Trial name
- VBXFLEX (NCT02080871)
- Testing
- Stenting of the Common and/or External Iliac Arteries
- Where
- 27 sites in United States, New Zealand
- Volunteers
- 134 people
- Sponsor
- W.L.Gore & Associates