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

NCT06075940 | Recruiting DMC

• 1 other identifier: CP002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Critical Limb-Threatening Ischemia; Critical Limb Ischemia; Critical Lower Limb Ischemia

Outcome Measures

Primary Outcomes (2)

• 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 Perioperative Death (POD) includes perioperative (30-day) mortality.

  POD at 30 Days and MALE at 6 months

• 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).

  6 months

Study Arms (1)

MAGNITUDE BRS

EXPERIMENTAL

Device: MAGNITUDE BRS

Interventions

MAGNITUDE BRS DEVICE

Treatment with the MAGNITUDE Scaffold

MAGNITUDE BRS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject (or their legally authorized representative) has provided written informed consent prior to any study-related procedure, using the form approved by the Human Research Ethics Committee.
• 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.
• Note: Questionnaire-based studies, or other studies that are non-invasive and do not require investigational devices or medications are allowed.
• Subject has symptomatic chronic limb-threatening ischemia, determined as Rutherford categories 4 or 5.
• Subject is ≥ 18 years and ≤ 90 years of age.
• Subject agrees to complete all protocol-required follow-up visits, including angiograms.
• Target lesion(s) in the infrapopliteal vessel(s) of the same limb located in any of the following vessels: tibioperoneal trunk (TPT), anterior tibial artery (ATA), posterior tibial artery (PTA), or peroneal artery.
• Target lesion(s) must be located in the proximal 2/3 of the native infrapopliteal vessels and at least 10 cm above the tibio-talar joint.
• Up to two (2) target lesions and two different arteries can be treated, where all target lesions must be successfully crossed with a guidewire prior to randomization.
• Note: For CTO, retrograde crossing of the lesion is allowed but treatment must be via antegrade.
• Note: The most distal lesion should be treated before treating more proximal lesions.
• Distal tibial and pedal runoff for each target lesion must be patent (free of lesions with \< 50% stenosis). If the index vessel is either anterior or posterior tibial artery, outflow must be contiguous with a patent dorsalis pedis or common plantar artery.
• Note: Inflow lesions may be treated during the index procedure prior to target lesion(s) using the standard of care (including drug-eluting devices), without wiring the target lesion, if possible. Treatment of inflow lesions in the target limb within prior 30 days is also allowed provided the treatment was successful.
• Note: Atherectomy of non-target lesions is not allowed.
• Target lesion must have reference vessel diameter is between 3.0 - 3.5 mm by angiography. Vessel size measured by IVUS is highly recommended to verify RVD.

You may not qualify if:

• 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.
• Note: Subjects of child-bearing potential must have a negative pregnancy test ≤ 28 days prior to the index procedure and agree to use contraception for 6 months.
• Estimated life expectancy \<1 year, in the opinion of the Investigator at the time of enrollment.
• Subject is permanently bedridden.
• Subject has known hypersensitivity or contraindication to device materials and their degradants (sirolimus, poly (L-lactide), poly (D, L-lactide), lactic acid, or platinum-iridium) or to study medications (including antiplatelet medications) or to contrast media and who cannot be adequately premedicated.
• Subject has planned surgery or procedure necessitating discontinuation of antiplatelet medications within 6 months after the index procedure.
• Subject has had revascularization procedure within the target vessel in the previous 3 months
• Subject has prior major amputation involving the target limb. Note: Major amputation of the contralateral limb is allowed.
• Subject has planned surgical or endovascular procedure within 6 months following the index procedure.
• Note: A planned minor amputation (toe and/or transmetatarsal amputation in either limb) is allowed. Treatment of inflow lesions in the target limb within prior 30 days is also allowed provided the treatment was successful (\< 30% residual stenosis, no thrombi, distal emboli or vessel rupture).
• Subject who has severe ischemia (ABI ≥ 0.39).
• Subject who has neuropathic lesion(s) with no ischemic component (wounds or ulcers occur on pressure zones of the foot with or without Type 2 diabetes , deformed foot/toes, hematoma, edema ).
• Subject has presence of osteomyelitis or any gangrene above the metatarsal-phalangeal joints, extensive tissue loss with exposed tendons or requiring complex or recurrent surgeries, full thickness heel ulcer, or pure neuropathic ulcers.
• Subject with uncontrolled diabetes with HbA1c \> 10%.

Sponsors & Collaborators

• R3 Vascular Inc.: lead

Study Sites (1)

Prince of Wales Hopsital

Randwick, New South Wales, 2031, Australia

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Central Study Contacts

Kristine Orosz

CONTACT

1 (408) 420-7446; korosz@r3vascular.com

Jane Beggs

CONTACT

1 (408) 306-8431; jbeggs@r3vascular.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects enrolled will be treated with the MAGNITUDE BRS

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 10, 2023
• Study Start: March 4, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)