Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease
ConditionChronic Limb-Threatening Ischemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorR3 Vascular Inc.
About this trial
The objective of this prospective, single-blinded, randomized controlled trial is to evaluate the safety and efficacy of the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions. Approximately 276 subjects will be randomized in a 1:1 ratio. The clinical investigation will be conducted at up to 60 clinical sites globally.
Eligibility criteria
Qualifiers
Subject agrees not to participate in any other investigational device or drug study for a period of at least 12 months following the index procedure.
Subject has symptomatic chronic limb-threatening ischemia, determined as Rutherford categories 4 or 5.
Subject is ≥ 18 years of age.
Subject agrees to complete all protocol-required follow-up visits, including angiograms.
Disqualifiers
Subject with Body Mass Index (BMI) < 18.
Subject is pregnant or nursing. Subjects who plan pregnancy during the clinical investigation follow-up period may not be enrolled.
Estimated life expectancy <1 year, in the opinion of the Investigator at the time of enrollment.
Subject is permanently bedridden.
Trial design
Treatments tested in this trial
- MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold
- Percutaneous Transluminal Angioplasty (PTA)
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov