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NCT06330493 · ClinicalTrials.gov registry record · NA
AcoArt Litos PCB Below-the-knee Global Trial
A NA study of Chronic Limb-Threatening Ischemia, sponsored by Acotec Scientific Co..
- Recruiting
- Registry status
- NA
- Development phase
- 288
- Enrollment target
- 10
- Study locations
NCT06330493: Recruiting NA study of Chronic Limb-Threatening Ischemia, sponsored by Acotec Scientific Co..
NCT06330493 is a NA study of Chronic Limb-Threatening Ischemia that is actively recruiting participants, run by Acotec Scientific Co.. The registered enrollment target is 288 participants, above the 153-participant average among 9 other Chronic Limb-Threatening Ischemia trials with a reported enrollment target (88% higher). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06330493, a NA study of Chronic Limb-Threatening Ischemia, is actively recruiting participants, sponsored by Acotec Scientific Co..
- RECRUITING
- Registry status
- NA
- Development phase
- 288 participants
- Enrollment target
- 10
- Study locations
Study 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)
Primary Outcome
Composite of freedom from major amputation (above ankle amputation) and primary patency at 12 months. Primary patency is defined as absence of target lesion occlusion (no flow) and/or target lesion binary restenosis as determined by duplex ultrasound or angiography and/or clinically driven target lesion revascularization (CD-TLR). Binary restenosis is defined as the presence of target lesion with a hemodynamically significant restenosis ≥ 50% by angiography or PSVR ≥ 2.4 by duplex ultrasound.
Conditions Studied
Interventions
- DEVICE PCB
- DEVICE PTA
Study Locations (10)
Florida
- Miami Vascular Center - Hialeah
- First Coast Cardiovascular Institute - Jacksonville
Other
- Medical University Graz - Graz
- AZ Sint Blasius Hospital - Dendermonde
Iowa
- Midwest Cardiovascular Research Foundation - Davenport
New York
- Columbia University/NYPH - New York
North Carolina
- South Charlotte General & Vascular Surgery - Charlotte
Rhode Island
- Miriam Hospital - Providence
Texas
- Clements University Hospital (UTSW) - Dallas
Virginia
- Sunrise Vascular - Danville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2024-10-10 |
| Est. Completion | 2032-10 |
| Phase | NA |
What NCT06330493 shows while recruiting
NCT06330493 is an interventional study that assigns participants to a tested intervention. The registered 288 participants enrollment target is mid-sized for trials with a published cap, above the 153-participant average among 9 other Chronic Limb-Threatening Ischemia trials with a reported enrollment target (88% higher).
The record links to 1 condition, with Chronic Limb-Threatening Ischemia appearing as the primary indexed condition, and to 2 interventions - of which PCB is the first listed.
NCT06330493 lists 10 locations in 8 states (Florida, Other, Iowa).
Frequently Asked Questions
What is clinical trial NCT06330493 about?
NCT06330493 is a clinical study titled "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 obstructions in the infrapopliteal arteries (located distal to the P3 se...
What is the current status of trial NCT06330493?
This trial is currently recruiting. It is a NA study. The enrollment target is 288 participants. The study started on 2024-10-10. Estimated completion is 2032-10.
What conditions does trial NCT06330493 study?
This clinical trial studies the following conditions: Chronic Limb-Threatening Ischemia.
What interventions are being tested in trial NCT06330493?
The interventions under investigation include: PCB (DEVICE), PTA (DEVICE).
Who is sponsoring clinical trial NCT06330493?
This trial is sponsored by Acotec Scientific Co., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06330493 being conducted?
This trial has 10 study locations across Florida, Iowa, New York, North Carolina, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Limb-Threatening Ischemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06330493's enrollment target sits among peer trials
288 3rd of 9 higher than 7 of 9 other Chronic Limb-Threatening Ischemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Limb-Threatening Ischemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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