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Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of Critical Limb Ischemia

NCT06122974 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 518

Last updated 2026-01-07

No results posted yet for this study

Summary

The purpose of this trial is to evaluate the safety and efficacy of the Drug Eluting Temporary Spur Stent System compared to PTA.

The Drug Eluting Temporary Spur Stent System is intended for use as a primary treatment in the infrapopliteal arteries for the treatment of de novo or restenotic lesions.

Conditions

  • Critical Limb Ischemia

Interventions

DEVICE

Drug Eluting Temporary Spur Stent System

The Spur Stent consists of a sirolimus coated stent and balloon that is retrievable after delivery of the sirolimus formulation.

DEVICE

Percutaneous Transluminal Balloon Angioplasty

A balloon catheter is inserted across a lesion and inflated to fracture and compress the plaque, creating a larger lumen and improved blood flow through the artery.

Sponsors & Collaborators

  • ReFlow Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Mahmood Razavi, MD · Providence Hospital St. Joseph

  • S. Jay Mathews, MD · Manatee Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2032-06-30
Completion
2037-12-31
FDA Device
Yes

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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 NCT06122974 on ClinicalTrials.gov