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
359 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject or their legally authorized representative has provided written informed consent before any study procedures
- Subject agrees not to participate in other investigational drug or device studies for at least 12 months after the procedure
- Subject has symptomatic chronic limb-threatening ischemia classified as Rutherford category 4 or 5
- Subject is 18 years of age or older
- Subject agrees to complete all follow-up visits including angiograms
- Target lesion(s) located in infrapopliteal vessels: tibioperoneal trunk, anterior tibial artery, posterior tibial artery, or peroneal artery
- Target lesions located in the proximal two-thirds of these vessels and at least 10 cm above the tibio-talar joint
- Up to two target lesions and two different arteries can be treated
- All target lesions must be successfully crossed with a guidewire before randomization
- Distal tibial and pedal runoff for each target lesion must be free of lesions with less than 50% stenosis
- Above-the-knee inflow lesions must be successfully treated with less than 30% stenosis and no complications
- Target lesion vessel diameter between 2.75 and 3.75 mm by angiography
- Target lesions must be de novo or restenosed with 70% or greater stenosis
- Total target lesion length must not exceed 11 cm and minimum lesion length must be greater than 14 mm
- Total scaffold length must not exceed 12 cm including 2 mm of normal vessel borders
- Target vessel must not have other significant non-target lesions (50% or greater stenosis)
- Tandem non-contiguous lesions allowed if separated by at least 2 cm plaque-free zone
- Target lesion stenting must not block access to patent named branches
- Non-target below-the-knee lesions must be treated successfully before randomization
- Subject has suitable common femoral vascular access
- At least one fully patent below-the-ankle artery without significant stenosis in the target limb
You will not qualify if you...
- Body mass index less than 18
- Pregnant or nursing individuals, or planning pregnancy during follow-up
- Estimated life expectancy less than one year
- Permanently bedridden
- Known allergy or contraindication to device materials, study medications, or contrast media
- Planned surgery requiring stopping antiplatelet medications within 6 months
- Revascularization procedure in target vessel within previous 3 months
- Prior major amputation involving the target limb
- Planned surgical or endovascular procedure within 6 months (minor amputations allowed)
- Severe ischemia with ABI greater than or equal to 0.39
- Neuropathic lesions without ischemic component
- Presence of osteomyelitis, gangrene above metatarsal-phalangeal joints, extensive tissue loss, full thickness heel ulcer, or pure neuropathic ulcers
- Uncontrolled diabetes with HbA1c greater than 10%
- Stroke or myocardial infarction within 3 months
- Acute renal failure, severe or end-stage kidney disease, or dialysis
- Active systemic infection
- Receiving immunosuppression or having known immunosuppressive or autoimmune disease
- Active malignancy or blood disorders within 1 year before or after procedure
- Incapacitated individuals without legal authority
- Significant comorbid conditions or medical, social, or psychological issues limiting participation
- Angiographic evidence of thromboembolism or atheroembolism in target or non-target vessels
- Non-target lesion in popliteal P3 segment or treated with atherectomy
- Presence of aneurysm or acute 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 allowed treatment zone
- Lesions with severe calcification
- Unsuccessful treatment of inflow arteries including popliteal P3 segment
- Absence of patent pedal artery or contiguous dorsalis pedis or common plantar arteries
- Target lesion requiring bifurcation treatment with scaffolding of both branches
- Lesions where successful predilatation cannot be achieved
- Planned atherectomy treatment of any lesion
AI-Screening
AI-Powered Screening
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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.
CONTACT
J
Josh Smale
CONTACT
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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