AcoArt Litos PCB Below-the-knee Global Trial
Public ClinicalTrials.gov record NCT06330493. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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)
Study identification
- NCT ID
- NCT06330493
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 75 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 10, 2025 (Actual)
- Primary completion
- Aug 24, 2026 (Actual)
- Completion
- Aug 24, 2026 (Actual)
- Last update posted
- Aug 26, 2026
2025 – 2026
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| John Muir Health | Concord | California | 94520 | — |
| California Cardiovascular Consultants and Medical Associates | Fremont | California | 94545 | — |
| Yale School of Medicine | New Haven | Connecticut | 06519 | — |
| Miami Vascular Center | Hialeah | Florida | 33012 | — |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32255 | — |
| American Endovascular and Amputation Prevention (AEAP) | Orange | New Jersey | 92868 | — |
| Columbia University/NYPH | New York | New York | 10032 | — |
| Cornell University | New York | New York | 10065 | — |
| South Charlotte General & Vascular Surgery | Charlotte | North Carolina | 28278 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195-0001 | — |
| Miriam Hospital | Providence | Rhode Island | 02906 | — |
| Ballad Health CVA Heart Institute | Kingsport | Tennessee | 37660 | — |
| Clements University Hospital (UTSW) | Dallas | Texas | 75390 | — |
| Baylor Scott & White Research Institute (BSW) | Fort Worth | Texas | 76104 | — |
| North Dallas Research Associates (NDRA) | McKinney | Texas | 75069 | — |
| Sunrise Vascular | Danville | Virginia | 24541 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06330493, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 26, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06330493 live on ClinicalTrials.gov.