Trials / Recruiting
RecruitingNCT06330493
AcoArt Litos PCB Below-the-knee Global Trial
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 288 (estimated)
- Sponsor
- Acotec Scientific Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PCB | Paclitaxel coated PTA balloon catheter |
| DEVICE | PTA | Non-coated FDA cleared (US) or CE-marked (EU) standard percutaneous transluminal angioplasty balloon catheter |
Timeline
- Start date
- 2024-10-10
- Primary completion
- 2028-10-01
- Completion
- 2032-10-01
- First posted
- 2024-03-26
- Last updated
- 2025-07-03
Locations
10 sites across 3 countries: United States, Austria, Belgium
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06330493. Inclusion in this directory is not an endorsement.