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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold
DeviceCLTI patients treated with MAGNITUDE BRS
Percutaneous Transluminal Angioplasty (PTA)
DeviceCLTI patients treated with PTA
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: MAGNITUDE BRSExperimental treatment 1 intervention
Group B: Percutaneous Transluminal Angioplasty (PTA)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary Safety Endpoint: Freedom from MALE+POD (Major Adverse Limb Event + Peri-Operative Death)
Major Adverse Limb Event (MALE) includes above ankle amputation in index limb, major re-intervention on index limb at 6 months and POD includes perioperative (30-day) mortality.
Time frame
POD at 30 Days and MALE at 6 months2
Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency
Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel, binary restenosis of target lesion and clinically-driven target lesion revascularization (CD-TLR).
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov