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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 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.

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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)

Conditions Studied

Chronic Limb-Threatening Ischemia

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

FieldValue
Enrollment Target 288 participants
Start Date 2024-10-10
Est. Completion 2032-10
Phase NA

Sponsor

Acotec Scientific Co.

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06330493

The ClinicalTrials.gov registry entry for NCT06330493 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 153-participant average among 9 other Chronic Limb-Threatening Ischemia trials with a reported enrollment target (88% higher). The listed sponsor is Acotec Scientific Co., which has 1 total studies on file at ClinicalTrials.gov.

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 reports 10 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.