Actively Recruiting
Evaluation of the MAGNITUDE ae Bioresorbable Drug-Eluting Scaffold (BRS) in the Treatment of Patients With Below the Knee Disease in Australia
Led by R3 Vascular Inc. · Updated on 2024-04-10
30
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the MAGNITUDE Bioresorbable Drug-Eluting Scaffold System to treat narrowed infrapopliteal arteries in patients with critical limb-threatening ischemia. This prospective, multi-center clinical investigation aims to assess this device's safety and effectiveness for below-the-knee disease. The study will enroll up to 30 participants across three clinical sites in Australia to better understand its potential role in treating these vascular conditions. Participants will receive treatment with the MAGNITUDE Scaffold device targeting lesions in infrapopliteal vessels such as the tibioperoneal trunk, anterior tibial artery, posterior tibial artery, or peroneal artery. The study includes detailed angiographic criteria for lesion location, size, and vessel characteristics. Treatment focuses on lesions with specific vessel diameters and stenosis levels, with up to two target lesions treated per participant. Follow-up includes angiograms and clinical evaluations to monitor vessel patency and limb salvage. During the study, participants will undergo protocol-required follow-up visits including angiograms at specified intervals. Researchers will monitor safety outcomes such as freedom from major adverse limb events and peri-operative death at 30 days and 6 months, as well as efficacy outcomes including composite limb salvage and primary vessel patency at 6 months. The total participation duration and ongoing safety monitoring aim to capture the device's performance and participant outcomes comprehensively.
CONDITIONS
Brief Title
Evaluation of the MAGNITUDE® Bioresorbable Drug-Eluting Scaffold in the Treatment of Patients With Below the Knee Disease in Australia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject (or legally authorized representative) has provided written informed consent before any study procedure.
- Subject agrees not to participate in any other investigational drug or device study for 12 months after the procedure.
- Subject has symptomatic chronic limb-threatening ischemia, Rutherford category 4 or 5.
- Subject is aged 18 to 90 years.
- Subject agrees to complete all follow-up visits, including angiograms.
- Target lesions are located in infrapopliteal vessels of the same limb (TPT, ATA, PTA, or peroneal artery).
- Lesions are in the proximal two-thirds of the infrapopliteal vessels and at least 10 cm above the tibio-talar joint.
- Up to two target lesions and two different arteries can be treated, all successfully crossed with a guidewire before randomization.
- Distal tibial and pedal runoff for each lesion must be patent with less than 50% stenosis.
- Inflow above-the-knee lesions must be successfully treated with less than 30% residual stenosis and no complications.
- Target lesion reference vessel diameter must be between 3.0 and 3.5 mm.
- Target lesions must be de novo or restenosed with at least 70% stenosis by angiography.
- 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 and include at least 2 mm of normal vessel on each side.
- Target vessel must have no other significant non-target lesions (50% or greater stenosis).
- Tandem non-contiguous lesions allowed if separated by at least 2 cm and total length does not exceed 11 cm.
- Stenting must not block access to main branches.
- Non-target below-the-knee lesions must be treated per standard care without thrombosis or embolization.
- Subject has suitable common femoral vascular access.
- At least one fully patent below-the-ankle artery without significant stenosis must be present in the target limb.
You will not qualify if you...
- Body mass index less than 18.
- Pregnant, nursing, or planning pregnancy during the study.
- Estimated life expectancy less than 1 year.
- Permanently bedridden.
- Known allergy or contraindication to device materials, study medications, or contrast media that cannot be premedicated.
- Planned surgery or procedure requiring stopping antiplatelet medications within 6 months after the procedure.
- Revascularization procedure on the target vessel within the previous 3 months.
- Prior major amputation involving the target limb.
- Planned surgical or endovascular procedure within 6 months after the procedure (minor amputations allowed).
- Severe ischemia with ABI 0.39 or higher.
- Neuropathic lesions with no ischemic component.
- Presence of osteomyelitis or gangrene above the metatarsal-phalangeal joints or extensive tissue loss.
- Uncontrolled diabetes with HbA1c over 10%.
- Prior stroke or heart attack within 3 months.
- Acute renal failure, severe kidney disease, or dialysis.
- Active systemic infection.
- Receiving immunosuppression therapy or having immunosuppressive or autoimmune diseases.
- Active cancer or blood disorders.
- Incapacitated individuals without legal authority.
- Significant medical, social, or psychological conditions limiting participation.
- Recent symptomatic or asymptomatic COVID-19 infection within specified timeframes.
- Angiographic evidence of thromboembolism or atheroembolism in target or non-target vessels.
- Non-target lesions in certain popliteal artery segments or treated with atherectomy.
- Presence of aneurysm or acute thrombus in major arteries.
- Prior below-the-knee bypass in the target limb.
- Previously stented lesions or stents in the target vessel.
- Distal significant lesions outside allowed treatment zones.
- Lesions with severe calcification.
- Unsuccessful treatment of inflow arteries stenosis.
- Absence of patent pedal artery or contiguous arteries for certain target vessels.
- Target lesion location 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
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 follow-up to 6 months
Participants receive treatment with the MAGNITUDE Bioresorbable Drug-Eluting Scaffold to address below the knee disease.
1 procedure visit and multiple follow-up visits over 6 months
Duration - Up to 6 months
Participants are monitored for safety and efficacy outcomes including limb salvage and vessel patency up to 6 months after treatment.
Follow-up visits at 30 days and at 6 months
Trial Site Locations
Total: 1 location
1
Prince of Wales Hopsital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
Research Team
K
Kristine Orosz
J
Jane Beggs
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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