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

REVA Medical, Inc.4 sites in 2 countries292 target enrollmentJune 10, 2022

ConditionsCritical Limb Ischemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Critical Limb Ischemia
Sponsor: REVA Medical, Inc.
Enrollment: 292
Locations: 4
Primary Endpoint: Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

June 10, 2022

End Date

March 31, 2029

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

REVA Medical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Clinical Inclusion Criteria
•Subjects must meet all of the following criteria to be eligible for enrollment in the trial:
•Subject is at least 18 years of age.
•Subject presents with symptomatic CLI classified as Rutherford category 4 or
•Subject agrees to comply with all-protocol specified procedures and follow-up assessments.
•Subject or subject's legal representative signs an IRB/EC approved informed consent form prior to study participation.
•Angiographic Inclusion Criteria
•Subjects must meet the following criteria to be eligible for participation in the study:
•Significant stenosis (\>70% diameter stenosis by visual estimate) of one or two native infrapopliteal lesions; if two lesions, each lesion should be in a separate infrapopliteal vessel in the same limb. Unstented restenotic lesions are permitted.
•Target vessel diameter between 2.5 mm and 3.75 mm and able to be treated with the available device size matrix.

Exclusion Criteria

•Clinical Exclusion Criteria
•Subjects will be excluded if any of the following criteria apply:
•Subject has severe medical comorbidities or other medical, social or psychological condition that could limit subject's ability to participate in the study or is associated with a life expectancy of less than 1 year.
•Subject has documented history of stroke within 3 months prior to the procedure.
•Subject has history of MI, within 30 days prior to the planned index procedure.
•Subjects with renal failure (estimated Glomerular Filtration Rate \[eGFR\] \< 30 ml/min).
•Subject has non-atherosclerotic disease resulting in occlusion (e.g., embolism, Buerger's disease, vasculitis).
•Subject presents with CLI classified as Rutherford category
•Subject has acute limb ischemia, defined as symptom onset occurring less than 14 days prior to the index procedure with associated loss of sensation or motor function.
•Subject had a major amputation that occurred less than one year prior to enrollment and subject is not independently ambulating.

Outcomes

Primary Outcomes

Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency

Time Frame: 6 Months

Freedom from the composite of above-the-ankle amputation, target lesion occlusion, and clinically driven target lesion revascularization (CD-TLR).

Primary Safety Endpoint: Freedom from Major Adverse Limb Events (MALE) and All-Cause Peri-Operative Death (POD)

Time Frame: 30 Days

Freedom from the composite of all-cause death, above-the-ankle amputation, or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving the infrapopliteal arteries.