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Evaluation of the MAGNITUDE® Bioresorbable Drug-Eluting Scaffold in the Treatment of Patients With Below the Knee Disease in Australia

NCT06075940 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-04-10

No results posted yet for this study

Summary

The objective of this prospective, multi-center, clinical investigation is to evaluate the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions. Up to 30 subjects will be enrolled at approximately 3 clinical sites in Australia.

Conditions

  • Critical Limb-Threatening Ischemia
  • Critical Limb Ischemia
  • Critical Lower Limb Ischemia

Interventions

DEVICE

MAGNITUDE BRS

Treatment with the MAGNITUDE Scaffold

Sponsors & Collaborators

  • R3 Vascular Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-04
Primary Completion
2026-12-31
Completion
2030-12-31

Countries

  • Australia

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 NCT06075940 on ClinicalTrials.gov