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Study of the R3 Vascular Drug-Eluting Bioresorbable Scaffold in Treating Below the Knee Arterial Disease

NCT04912323 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-04-09

No results posted yet for this study

Summary

This first-in-human clinical feasibility study will evaluate the safety and performance of the R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffold and Delivery System in patients undergoing treatment for peripheral arterial disease severe enough to have significantly reduced the blood supply to their leg. The severe reduction in blood flow causes lifestyle limiting leg pain for these patients, and may lead to amputation of the affected limb due to the loss of tissue in the leg or foot from ulcers or gangrene. The investigational device being studied in this trial is intended to restore blood flow to the affected limb, providing symptomatic relief to the patient and reducing the risk of limb amputation. The scaffold is a type of vascular stent placed within the diseased artery below the knee to improve blood flow. Unlike commercially available metallic stents which are permanently placed within the artery, the MAGNITUDE® Bioresorbable scaffold is made of a polymer material that will completely dissolve away over time, providing the support necessary to the artery while it is healing after the treatment procedure and then slowly disappearing from the artery once that support is no longer needed. The investigational scaffold has been successfully used to treat vascular blockages in the coronary arteries of the heart, but the RESOLV I study will be the first time this device has been used to improve blood flow in the arteries of the lower leg. Patients enrolled in this study may have up to three vascular blockages in their lower leg arteries treated with the MAGNITUDE® Bioresorbable scaffold, and then will be assessed over the course of the following five years to evaluate whether the investigational treatment was successful in safely alleviating their leg pain and other symptoms.

Conditions

  • Peripheral Arterial Disease
  • Atherosclerotic Lesion
  • Lower Extremity Ischemia
  • Lower Extremity Claudication

Interventions

DEVICE

Percutaneous Implantation of the MAGNITUDE® Bioresorbable Arterial Scaffold

Placement of one or more MAGNITUDE® bioresorbable scaffolds using a percutaneous technique at one or more arterial stenoses.

Sponsors & Collaborators

  • Massachusetts General Physicians Organization / Vascore

    collaborator UNKNOWN

  • Cardiovascular Research Foundation, New York

    collaborator OTHER

  • R3 Vascular Inc.

    lead INDUSTRY

Principal Investigators

  • Juan F Granada, MD · Cardiovascular Research Foundation (CRF)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-17
Primary Completion
2026-12-31
Completion
2031-12-31
FDA Device
Yes

Countries

  • Austria
  • Canada
  • Italy

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 NCT04912323 on ClinicalTrials.gov