Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06075940

Evaluation of the MAGNITUDE® Bioresorbable Drug-Eluting Scaffold 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

356 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The objective of this prospective, multi-center, clinical investigation is to evaluate the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions. Up to 30 subjects will be enrolled at approximately 3 clinical sites in Australia.

CONDITIONS

Official Title

Evaluation of the MAGNITUDE® Bioresorbable Drug-Eluting Scaffold in the Treatment of Patients With Below the Knee Disease in Australia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subject (or their legally authorized representative) has provided written informed consent before any study procedure.
  • Subject agrees not to participate in other investigational device or drug studies for 12 months after the procedure.
  • Subject has symptomatic chronic limb-threatening ischemia, Rutherford categories 4 or 5.
  • Subject is between 18 and 90 years old.
  • Subject agrees to complete all required follow-up visits including angiograms.
  • Target lesion(s) are in infrapopliteal vessels: tibioperoneal trunk, anterior tibial, posterior tibial, or peroneal artery.
  • Lesions are located in the proximal two-thirds of the vessel and at least 10 cm above the tibio-talar joint.
  • Up to two target lesions in two different arteries can be treated, crossed successfully with a guidewire before randomization.
  • Distal tibial and pedal runoff vessels must be patent with less than 50% stenosis.
  • Above-the-knee inflow lesions must be treated successfully with less than 30% residual stenosis.
  • Target lesion vessel diameter between 3.0 and 3.5 mm.
  • Lesions are de novo or restenosed with at least 70% stenosis; in-stent restenosis is excluded.
  • Total lesion length must not exceed 11 cm; minimum lesion length more than 14 mm.
  • Total scaffold length must not exceed 12 cm and include 2 mm of normal vessel on each side.
  • No other significant non-target lesions (50% or more stenosis) in the target vessel.
  • Tandem non-contiguous lesions allowed if separated by at least 2 cm plaque-free zone.
  • Stenting must not block access to main branches.
  • Non-target below-the-knee lesions must be treated successfully before randomization.
  • Suitable common femoral vascular access must be available.
  • At least one fully patent below-the-ankle artery without significant stenosis must be present.
Not Eligible

You will not qualify if you...

  • Body Mass Index (BMI) less than 18.
  • Pregnant or nursing, or plans to become pregnant during the study; negative pregnancy test required for females of childbearing potential.
  • 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.
  • Revascularization procedure on the target vessel within past 3 months.
  • Prior major amputation of the target limb.
  • Planned surgical or endovascular procedure within 6 months after the index procedure.
  • Severe ischemia with ankle-brachial index (ABI) of 0.39 or higher.
  • 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 before the procedure.
  • Acute renal failure, severe or end-stage kidney disease (eGFR less than 30 mL/min), or dialysis.
  • Active systemic infection.
  • Receiving immunosuppression therapy or having known immunosuppressive or autoimmune disease.
  • Active malignancy or blood disorders affecting blood cell counts within 1 year prior or after procedure.
  • Incapacitated individuals without legal authority.
  • Significant medical, social, or psychological conditions limiting participation or compliance, including recent symptomatic or asymptomatic COVID-19 infection.
  • 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 on target limb.
  • Previously stented lesions or presence of stents in target vessel.
  • Distal significant lesions outside allowed treatment zone.
  • Lesions with severe calcification.
  • Unsuccessful treatment of inflow artery stenosis.
  • Absence of patent pedal artery or contiguous dorsalis pedis or plantar arteries.
  • Lesions requiring bifurcation treatment with scaffolding of both branches.
  • Lesions where predilatation cannot be achieved.
  • Planned atherectomy treatment of any target or non-target lesion.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Prince of Wales Hopsital

Randwick, New South Wales, Australia, 2031

Actively Recruiting

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Research Team

K

Kristine Orosz

CONTACT

J

Jane Beggs

CONTACT

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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