MOTIV Sirolimus-Eluting Bioresorbable Scaffold for Ischemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University Leipzig, Leipzig, Germany
Ischemia+1 More
MOTIV Sirolimus-Eluting Bioresorbable Scaffold - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions

  • Ischemia

Treatment Effectiveness

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 6 Months

30 Days
Primary Safety Endpoint: Freedom from Major Adverse Limb Events (MALE) and All-Cause Peri-Operative Death (POD)
6 Months
Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency

Trial Safety

Trial Design

2 Treatment Groups

Percutaneous Transluminal Angioplasty (PTA)
1 of 2
MOTIV Sirolimus-Eluting Bioresorbable Scaffold
1 of 2
Active Control
Experimental Treatment

292 Total Participants · 2 Treatment Groups

Primary Treatment: MOTIV Sirolimus-Eluting Bioresorbable Scaffold · No Placebo Group · N/A

MOTIV Sirolimus-Eluting Bioresorbable Scaffold
Device
Experimental Group · 1 Intervention: MOTIV Sirolimus-Eluting Bioresorbable Scaffold · Intervention Types: Device
Percutaneous Transluminal Angioplasty (PTA)
Device
ActiveComparator Group · 1 Intervention: Percutaneous Transluminal Angioplasty (PTA) Device · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Closest Location: Adventist Health · Saint Helena, CA
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N/AFirst Recorded Clinical Trial
2 TrialsResearching Ischemia
0 CompletedClinical Trials

Who is running the clinical trial?

REVA Medical, Inc.Lead Sponsor
6 Previous Clinical Trials
1,915 Total Patients Enrolled
1 Trials studying Ischemia
49 Patients Enrolled for Ischemia
Ehrin Armstrong, MDPrincipal InvestigatorAdventist Health
Andrej Schmidt, PD Dr.Principal InvestigatorUniversity Leipzig

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at least 18 years of age.
The subject presents with symptomatic CLI classified as Rutherford category 4 or 5.
You agree to comply with all-protocol specified procedures and follow-up assessments.
Each target lesion is treatable by a maximum of 3 scaffolds, and all target lesions combined must be treatable by a maximum of 4 scaffolds.
Vessel diameter of 2.5 mm to 3.75 mm
The total scaffold length among all target lesions must not exceed 120 mm.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.