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Clinical Study Evaluating Use of the CapBuster Medical Device System for the Crossing of Chronic Total Occlusions

NCT04710342 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-02-21

No results posted yet for this study

Summary

This study represents a prospective, non-randomized, dual-center clinical study to evaluate the safety and effectiveness of the CapBuster System in crossing a de novo or restenotic infrapopliteal chronic total occlusion.

Measures of safety and efficacy will be assessed through 30 days post-intervention.

Conditions

  • Chronic Total Occlusion

Interventions

DEVICE

CapBuster

Evaluate the safety and effectiveness of the CapBuster System in crossing de novo or restenotic chronic total occlusions in infrapopliteal peripheral arteries.

Sponsors & Collaborators

  • Ospedale Regionale di Lugano

    collaborator OTHER

  • St. Antonius Hospital

    collaborator OTHER

  • Praxis Medical Devices Ltd

    lead INDUSTRY

Principal Investigators

  • Jihad Mustapha, Dr · Advanced Cardiac & Vascular Centers for Amputation Prevention Grand Rapids, MI 49525 USA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-21
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Netherlands

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 NCT04710342 on ClinicalTrials.gov