Actively Recruiting
Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease
Led by R3 Vascular Inc. · Updated on 2026-02-06
300
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of the MAGNITUDE Bioresorbable Sirolimus-Eluting Scaffold (BRS) System for treating narrowed blood vessels below the knee in people with chronic limb-threatening ischemia. This randomized controlled trial will include about 276 participants who have specific artery blockages in the lower leg. The study aims to compare the MAGNITUDE BRS device with a standard procedure called Percutaneous Transluminal Angioplasty (PTA). Participants will be randomly assigned to receive either the MAGNITUDE BRS device or the PTA procedure. Both treatments target narrowed infrapopliteal arteries, including vessels like the tibioperoneal trunk and tibial arteries. The trial includes careful criteria on lesion size, location, and vessel condition to ensure appropriate treatment. Researchers will follow participants to assess the safety and success of the procedures, focusing on limb health and vessel openness. During the study, participants will undergo follow-up visits including angiograms to monitor the treated blood vessels. Researchers will track major adverse limb events, peri-operative death within 30 days, limb salvage, and vessel patency over six months. Participants need to complete all scheduled visits and evaluations, which include clinical assessments and imaging. The study is planned to be conducted at up to 60 sites globally and will continue until March 2032.
CONDITIONS
Brief Title
Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent before any study procedures
- Agreed not to participate in other investigational device or drug studies for 12 months after the procedure
- Have symptomatic chronic limb-threatening ischemia, Rutherford category 4 or 5
- Are 18 years of age or older
- Agree to complete all follow-up visits including angiograms
- Have target lesions in infrapopliteal vessels such as tibioperoneal trunk, anterior tibial artery, posterior tibial artery, or peroneal artery
- Lesions located in the proximal two-thirds of the infrapopliteal vessels and at least 10 cm above the tibio-talar joint
- All target lesions must be crossed with a guidewire before randomization
- Have patent distal tibial and pedal runoff vessels without significant stenosis
- Successfully treated inflow above-the-knee lesions with less than 30% stenosis
- Target lesion vessel diameter between 2.75 and 3.75 mm
- Target lesions are new or restenosed with at least 70% stenosis, excluding in-stent restenosis
- Total target lesion length not exceeding 11 cm
- Minimum target lesion length greater than 14 mm
- Total scaffold length no more than 12 cm including pre-dilatation borders
- No other significant lesions in target vessel
- Tandem non-contiguous lesions allowed if plaque-free zone of at least 2 cm between lesions
- Stenting does not block access to main branches
- Non-target below-the-knee lesions treated per standard care without thrombosis
- Suitable common femoral vascular access
- At least one fully patent below-the-ankle artery without significant stenosis
You will not qualify if you...
- Body Mass Index less than 18
- Pregnant, nursing, or planning pregnancy during follow-up
- Estimated life expectancy less than 1 year
- Permanently bedridden
- Known allergy or contraindication to device materials or study medications
- Planned surgery requiring stopping antiplatelet medications within 6 months
- Revascularization in target vessel within 3 months
- Prior major amputation involving target limb
- Planned surgical or endovascular procedures within 6 months, except minor amputations
- Severe ischemia with ankle-brachial index 0.39 or higher
- Neuropathic lesions without ischemic component
- Osteomyelitis, gangrene above metatarsal-phalangeal joints, extensive tissue loss, or certain ulcers
- Uncontrolled diabetes with HbA1c over 10%
- Stroke or heart attack within 3 months
- Acute or severe kidney failure or dialysis
- Active systemic infection
- Immunosuppressive therapy or autoimmune diseases
- Active cancer or blood disorders
- Mental incapacity or lack of legal authority
- Significant comorbidities or conditions limiting participation
- Recent symptomatic or asymptomatic COVID-19 infection
- Angiographic evidence of thromboembolism or atheroembolism
- Lesions in popliteal P3 segment or treated with atherectomy
- Aneurysm or thrombus in aorta or lower extremity arteries
- Prior below-the-knee bypass in target limb
- Presence of stents in target vessel
- Distal significant lesions outside treatment zone
- Severe calcification of lesions
- Unsuccessful treatment of inflow arteries
- Absence of patent pedal artery or contiguous vessels
- Lesion location requiring kissing scaffold treatment
- Lesions unable to be predilated
- Planned atherectomy for any lesion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate post-procedure care
Participants receive either the MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold or Percutaneous Transluminal Angioplasty (PTA) to treat below the knee disease.
1 procedure visit
Duration - 6 months
Participants are monitored for safety and efficacy outcomes including limb salvage and vessel patency.
Follow-up visits including angiograms at multiple time points up to 6 months
Trial Site Locations
Total: 3 locations
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
2
CUMC/NYP
New York, New York, United States, 10032
Actively Recruiting
3
Staten Island University Hospital - Northwell Health
Staten Island, New York, United States, 10305
Actively Recruiting
Research Team
M
Megan Hill, B.S.
J
Josh Smale
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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