RecruitingNot ApplicableNCT05406622

MOTIV BTK Randomized Controlled Trial

A Prospective, Multicenter, Single Blind, Randomized Controlled Trial Evaluating the Safety and Effectiveness of the MOTIV Sirolimus-Eluting Bioresorbable Vascular Scaffold Compared With Plain Balloon Angioplasty for the Treatment of Infrapopliteal Lesions


Sponsor

REVA Medical, Inc.

Enrollment

292 participants

Start Date

Jun 10, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a special type of drug-eluting scaffold (a tiny mesh tube that slowly releases medication) in arteries below the knee for people with critical limb ischemia — a severe circulation problem where too little blood reaches the legs, threatening the limb. You may be eligible if: - You are at least 18 years old - You have critical limb ischemia classified as Rutherford category 4 or 5 - You have a significant artery blockage in a vessel below the knee that meets specific size and location requirements You may NOT be eligible if: - Your expected survival is less than 1 year - You had a stroke within 3 months or a heart attack within 30 days - You have kidney failure (eGFR < 30 mL/min) - You require a major amputation - You are pregnant or nursing - You have active infection or a coagulation disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMOTIV Sirolimus-Eluting Bioresorbable Scaffold

Participants will receive the MOTIV device

DEVICEPercutaneous Transluminal Angioplasty (PTA) Device

Participants will receive PTA treatment


Locations(4)

Adventist Health

St. Helena, California, United States

UnityPoint Health Trinity Bettendorf Hospital

Bettendorf, Iowa, United States

Cardiovascular Medicine PC

Davenport, Iowa, United States

University Leipzig

Leipzig, Germany

View Full Details on ClinicalTrials.gov

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NCT05406622


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