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

Not Applicable

Recruiting

• Conditions: Critical Lower Limb Ischemia; Critical Limb-Threatening Ischemia; Critical Limb Ischemia
• Interventions: Device: MAGNITUDE BRS

• Registration Number: NCT06075940
• Lead Sponsor: R3 Vascular Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-28
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-10
• Study Start: 2024-03-04
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10
• Primary Completion: 2026-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MAGNITUDE BRS	MAGNITUDE BRS	-

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint: Freedom from MALE+POD (Major Adverse Limb Event + Peri-Operative Death)	POD at 30 Days and MALE at 6 months	Major Adverse Limb Event (MALE) includes above ankle amputation in index limb, major re-intervention on index limb at 6 months and Perioperative Death (POD) includes perioperative (30-day) mortality.
Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency	6 months	Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel, binary restenosis of target lesion and clinically-driven target lesion revascularization (CD-TLR).

Trial Locations

Locations (1)

Prince of Wales Hopsital; 🇦🇺 Randwick, New South Wales, Australia