Prospective Multi-Center Randomized Controlled Trial to Evaluate the Safety and Efficacy of AcoArt Litos Paclitaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Versus Non-Coated Standard Balloon Angioplasty for the Treatment of Infrapopliteal Obstructions in Patients With Chronic Limb-Threatening Ischemia
Acotec Scientific Co., Ltd
Summary
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 obstructions in the infrapopliteal arteries (located distal to the P3 segment of the popliteal artery and extending to the tibiotalar joint) in patients presenting with chronic limb-threatening ischemia (CLTI)(Rutherford 4-5)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: \- General Inclusion Criteria 1. Age ≥ 18 years at the time of consent; 2. Subjects has been informed of the nature of the study, is willing to comply with all required follow-up evaluations within the defined follow-up visit windows and has signed an Institutional Review Board(IRB)/Ethics Commitee(EC) approved consent form; 3. Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation. Female subjects will be exempted from this req…
Interventions
- DevicePCB
Paclitaxel coated PTA balloon catheter
- DevicePTA
Non-coated FDA cleared (US) or CE-marked (EU) standard percutaneous transluminal angioplasty balloon catheter
Locations (10)
- Miami Vascular CenterHialeah, Florida
- First Coast Cardiovascular InstituteJacksonville, Florida
- Midwest Cardiovascular Research FoundationDavenport, Iowa
- Columbia University/NYPHNew York, New York
- South Charlotte General & Vascular SurgeryCharlotte, North Carolina
- Miriam HospitalProvidence, Rhode Island