Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease

NCT06071429 | Recruiting DMC

• 1 other identifier: CP001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

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

Chronic Limb-Threatening 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 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 (2)

MAGNITUDE BRS

EXPERIMENTAL

Participants who receive the MAGNITUDE BRS device will be included in this arm

Device: MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold

Percutaneous Transluminal Angioplasty (PTA)

ACTIVE COMPARATOR

Participants who receive a PTA device will be included in this arm

Device: Percutaneous Transluminal Angioplasty (PTA)

Interventions

MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold DEVICE

CLTI patients treated with MAGNITUDE BRS

MAGNITUDE BRS

Percutaneous Transluminal Angioplasty (PTA) DEVICE

CLTI patients treated with PTA

Percutaneous Transluminal Angioplasty (PTA)

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 Institutional Review Board / 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 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.
• Note: Up to two (2) target lesions and two different arteries can be treated
• 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 must 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.
• Inflow above-the-knee lesions must be treated successfully (\< 30% diameter stenosis by angiography without evidence of distal embolization, thrombus formation, or vessel rupture).
• 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.

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 (above or below the knee or above the ankle) 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.

Sponsors & Collaborators

• R3 Vascular Inc.: lead

Study Sites (3)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

CUMC/NYP

New York, New York, 10032, United States

RECRUITING

Staten Island University Hospital - Northwell Health

Staten Island, New York, 10305, United States

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Angioplasty

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

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Eric Secemsky, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

• Marianne Brodmann, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

• Ramon L Varcoe, MD

  Prince of Wales Private Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Hill, B.S.

CONTACT

1(904)540-3844; mhill@r3vascular.com

Josh Smale

CONTACT

1(480)244-9523‬; jsmale@r3vascular.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 6, 2023
• Study Start: April 11, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2032
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)