Clinical trials: Peripheral Endovascular Intervention
Peripheral Artery Disease, Peripheral Vascular Disease
Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents
The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native…
- Trial name
- BIOFLEX-I (NCT01319812)
- Testing
- Astron Stents, Pulsar Stents
- Where
- 35 sites in United States, Canada
- Volunteers
- 463 people
- Sponsor
- Biotronik, Inc.
Iliac Artery Disease, Peripheral Artery Disease
AndraTec PMCF Study : Investigating the AndraTec Guidewires,PTA Balloons and Stents in Iliac Disease.
This PMCF study is designed as prospective, multi-center study to collect real-life data. The rationale of this study is to confirm and support the clinical safety and performance of the aforementioned products in 200 patients…
- Trial name
- NCT04822727
- Testing
- 1 or more AndraTec devices (see description for list of devices)
- Sponsor
- Dr. Sabrina Overhagen
Peripheral Vascular Disease
Luminor Registry: Registry of the Results of Angioplasty With Drug-eluting Balloon (Paclitaxel) in the Treatment of Infrainguinal Occlusive Lesions and Restenosis From Prior Endovascular Procedures in This Sector.
The purpose of the study is to obtain data regarding safety and efficacy of drug-eluting balloon luminor 14 \& luminor 35 in the treatment of infrainguinal occlusive lesions (superficial femoral artery (SFA), popliteal artery…
- Trial name
- NCT02458911
- Testing
- Paclitaxel-eluting balloon
- Where
- Spain
- Volunteers
- 214 people
- Sponsor
- iVascular S.L.U.
Peripheral Arterial Disease, Myocardial Injury
Cardiovascular Risk in Peripheral Artery Disease Patients Undergoing Endovascular Revascularisation
This study will investigate heart-related complications in patients with peripheral arterial disease (PAD) undergoing endovascular revascularization procedures to improve blood flow in the legs.
- Conditions
- Peripheral Arterial Disease, Myocardial Injury, Troponin, NT-proBNP
- Trial name
- RISK (NCT07599540)
- Where
- Slovenia
- Volunteers
- 500 people
- Sponsor
- University Medical Centre Ljubljana
Chronic Limb-Threatening Ischemia
IVUS Guidance in BTK Interventions
Chronic limb-threatening ischemia (CLTI) is a severe form of peripheral artery disease in which very poor blood flow in the arteries below the knee can cause rest pain, non-healing wounds, and even loss of the limb.
- Trial name
- IMAGE-BTK (NCT07731997)
- Testing
- Intravascular ultrasound-guided EVT, Angiography-guided EVT
- Where
- 4 sites in Taiwan
- Volunteers
- 212 people
- Sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
V-INTERVENTION will evaluate the effectiveness of inclisiran in preventing major cardiovascular and limb events in patients receiving percutaneous coronary or peripheral arterial revascularization.
- Trial name
- V-INTERVENTION (NCT06909565)
- Testing
- Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
- Where
- 147 sites in United States
- Volunteers
- 6,000 people
- Sponsor
- Duke University
Peripheral Arterial Disease, Chronic Kidney Diseases
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
This research trial will test whether using carbon dioxide as a contrast medium during surgery to open blocked leg arteries can prevent kidney injury.
- Conditions
- Peripheral Arterial Disease, Chronic Kidney Diseases, Acute Kidney Injury
- Trial name
- KID (NCT07891988)
- Testing
- Iodinated contrast medium, CO2 automated injector contrast medium
- Where
- 6 sites in United Kingdom
- Volunteers
- 184 people
- Sponsor
- University of Leicester
Peripheral Artery Disease, Access Site Complication
BIOTRONIK 4French for AMBulatory Peripheral Intervention
BIOTRONIK 4French for AMBulatory peripheral intervention. A multicenter, controlled trial comparing 4French versus 6French femoral access for endovascular treatment of lower-extremity peripheral artery disease in an ambulatory…
- Conditions
- Peripheral Artery Disease, Access Site Complication, Outpatient Treatment
- Trial name
- BIO4AMB (NCT03044002)
- Testing
- Biotronik 4 French Portfolio, 6 French Portfolio
- Where
- 5 sites in Austria, Belgium and 2 more
- Volunteers
- 821 people
- Sponsor
- Biotronik AG
Arteriopathy
Safety of Fusion Guidance During Peripheral Revascularisation
Study the Patient and staff Safety regarding the radiation exposure during the procedure with and without the fusion imaging guidance technology in treatment of peripheral artery disease.
- Trial name
- SOFtPERIPHERAL (NCT03546881)
- Testing
- fusion imaging guidance technology, 2D X-ray screen
- Where
- France
- Volunteers
- 77 people
- Sponsor
- Nantes University Hospital
Peripheral Arterial Disease, Endovascular Procedures
Short vs Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization
The primary objective of the trial is to evaluate short versus long duration dual antiplatelet therapy in patients undergoing lower extremity endovascular revascularization.
- Trial name
- NCT02433587
- Testing
- Aspirin, Clopidogrel
- Where
- United States
- Sponsor
- University Hospitals Cleveland Medical Center
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
Coronary Artery Disease, Peripheral Arterial Disease
Evaluate Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions
This is a prospective, multi-center, single-group post-market study. It is planned to be carried out in about 3 clinical institutions, and a total of 60 subjects are expected to be enrolled.
- Trial name
- NCT05747287
- Testing
- microcatheter
- Where
- 3 sites in China
- Volunteers
- 60 people
- Sponsor
- BrosMed Medical Co., Ltd
Peripheral Arterial Disease
The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)
The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System when used as indicated in 159 subjects with symptomatic infrainguinal peripheral arterial…
- Trial name
- GREAT (NCT06321575)
- Testing
- Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS)
- Where
- 20 sites in United States
- Volunteers
- 159 people
- Sponsor
- Nipro Vascular Innovations Americas, Inc
Peripheral Arterial Disease
Vascular Trial Associated Registry Pilot
The purpose of this investigator-initiated, multicenter, open label, randomized trial is to evaluate 1 month vs. 6 months of dual antiplatelet therapy (DAPT) in patients undergoing lower extremity endovascular revascularization.
- Trial name
- VSTAR-P (NCT07076082)
- Testing
- Clopidogrel (Plavix) Pharmacogenetic Test Reagents
- Where
- 2 sites in United States
- Volunteers
- 350 people
- Sponsor
- Corewell Health West
Vascular Closure, Endovascular Procedure
Post-Market Clinical Investigation of the FemoSeal™ VCS: A Prospective, Multi-Center Observational European Study
The study aims to further demonstrate the safety and effectiveness of the FemoSeal™ VCS in achieving hemostasis following percutaneous endovascular procedures performed via the common femoral artery (CFA) access site.
- Conditions
- Vascular Closure, Endovascular Procedure, Hemostasis, Peripheral Vascular Disease
- Trial name
- FEMOSEAL CLOSE (NCT05027698)
- Where
- 3 sites in Belgium, France and 1 more
- Volunteers
- 230 people
- Sponsor
- Terumo Europe N.V.
Peripheral Arterial Disease
Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study)
Peripheral arterial disease (PAD) occurs when arteries become narrowed or hardened because of a build-up of plaque or fat deposits.
- Trial name
- NCT00687076
- Testing
- Ezetimibe, Niaspan, Statin therapy
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Baylor College of Medicine
Peripheral Vascular Diseases, Blood Pressure
Intraoperative Simultaneous Pressure Guided Revascularization Study
This study aims to determine whether intraoperative physiologic measurements of blood flow to the leg during endovascular treatment of Peripheral Arterial Disease (PAD) can predict future clinical outcomes.
- Conditions
- Peripheral Vascular Diseases, Blood Pressure, Monitoring, Intraoperative, Clinical Decision-Making
- Trial name
- INSTANT (NCT03875846)
- Testing
- Intraoperative Hemodynamic Pressures, Contrast Flow Rate
- Where
- Canada
- Volunteers
- 80 people
- Sponsor
- Mark Rockley
Peripheral Artery Disease
Predicting Outcomes of PAD Patients Undergoing Endovascular Intervention With CTA
Lower extremity peripheral artery disease (PAD), the third leading cause of atherosclerotic cardiovascular morbidity following coronary artery disease and stroke, affect 200 million people worldwide and is associated with high…
- Trial name
- NCT03974880
- Where
- China
- Volunteers
- 480 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Artery Disease
Investigating the Safety and Clinical Performance of Eight iVascular Devices for Endovascular Intervention in Renal, Iliac or Femoral Arteries
The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-world population of 209 patients who underwent an endovascular intervention within standard-of-care of…
- Trial name
- NCT05902923
- Testing
- endovascular intervention
- Where
- 6 sites in France
- Volunteers
- 209 people
- Sponsor
- iVascular S.L.U.
Peripheral Arterial Disease(PAD)
Korean Vascular Intervention Society Multicenter Registry Study on Outcomes of Endovascular Therapy in Lower Limb Artery Diseases (K-VIS ELLA): (A Retrospective & Prospective Observational Study)
1. Study design: multicenter retrospective and prospective observational study 2. Study Cohort : 1. Retrospective cohort: This cohort retrospectively enrolls patients with lower extremity artery disease who underwent endovascular…
- Trial name
- NCT02748226
- Testing
- endovascular treatment
- Where
- South Korea
- Volunteers
- 12,000 people
- Sponsor
- Yonsei University