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AcoArt Litos PCB Below-the-knee Global Trial

NCT06330493 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2025-07-03

No results posted yet for this 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

  • Chronic Limb-Threatening Ischemia

Interventions

DEVICE

PCB

Paclitaxel coated PTA balloon catheter

DEVICE

PTA

Non-coated FDA cleared (US) or CE-marked (EU) standard percutaneous transluminal angioplasty balloon catheter

Sponsors & Collaborators

  • Acotec Scientific Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Peter Schneider, MD, PhD · University of California, San Francisco

  • Sahil Parikh, MD, PhD · Columbia University

  • Thomas Zeller, MD, PhD · University of Herzzentrum Freiburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2028-10-31
Completion
2032-10-31
FDA Device
Yes

Countries

  • United States
  • Austria
  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06330493 on ClinicalTrials.gov