Study of the R3 Vascular Drug-Eluting Bioresorbable Scaffold in Treating Below the Knee Arterial Disease

NCT04912323 | Recruiting FDA Device

• 1 other identifier: TP-1501
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 7

Brief Summary

This first-in-human clinical feasibility study will evaluate the safety and performance of the R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffold and Delivery System in patients undergoing treatment for peripheral arterial disease severe enough to have significantly reduced the blood supply to their leg. The severe reduction in blood flow causes lifestyle limiting leg pain for these patients, and may lead to amputation of the affected limb due to the loss of tissue in the leg or foot from ulcers or gangrene. The investigational device being studied in this trial is intended to restore blood flow to the affected limb, providing symptomatic relief to the patient and reducing the risk of limb amputation. The scaffold is a type of vascular stent placed within the diseased artery below the knee to improve blood flow. Unlike commercially available metallic stents which are permanently placed within the artery, the MAGNITUDE® Bioresorbable scaffold is made of a polymer material that will completely dissolve away over time, providing the support necessary to the artery while it is healing after the treatment procedure and then slowly disappearing from the artery once that support is no longer needed. The investigational scaffold has been successfully used to treat vascular blockages in the coronary arteries of the heart, but the RESOLV I study will be the first time this device has been used to improve blood flow in the arteries of the lower leg. Patients enrolled in this study may have up to three vascular blockages in their lower leg arteries treated with the MAGNITUDE® Bioresorbable scaffold, and then will be assessed over the course of the following five years to evaluate whether the investigational treatment was successful in safely alleviating their leg pain and other symptoms.

Conditions

Peripheral Arterial Disease; Atherosclerotic Lesion; Lower Extremity Ischemia; Lower Extremity Claudication

Keywords

Claudication; Leg Pain; Lower Extremities; Lower Limb; Blocked Leg Artery; Limb Ischemia

Outcome Measures

Primary Outcomes (2)

• (Safety) Freedom from MALE and POD

  Composite endpoint of freedom from Major Adverse Limb Event ("MALE", which includes above ankle amputation in the index limb or major re-intervention) and Peri-Operative Death ("POD")

  MALE is assessed at 180 days and POD is assessed at 30 days (post implantation procedure)

• (Performance) Primary Patency of the Target Lesion(s)

  Freedom from hemodynamically significant stenosis by angiography (≥ 50% diameter stenosis), or duplex ultrasound (absence of flow per core lab) when angiography is not available, without additional target lesion revascularization

  Assessed at 180 days (post implantation procedure)

Secondary Outcomes (12)

• Technical Success

  Assessed from start of treatment procedure to end of treatment procedure

• Procedural Success

  Assessed from start of treatment procedure to hospital discharge after treatment procedure, approximately same day or day after treatment procedure

• Angiographic Acute Gain

  Assessed at 180 days (post implantation procedure)

• Angiographic Late Lumen Loss

  Assessed at 180 days (post implantation procedure)

• Angiographic Binary Restenosis

  Assessed at 180 days (post implantation procedure)

Study Arms (1)

MAGNITUDE® Scaffold

EXPERIMENTAL

Subject with up to three study lesions treated by implanting a maximum of 3 R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffolds

Device: Percutaneous Implantation of the MAGNITUDE® Bioresorbable Arterial Scaffold

Interventions

Percutaneous Implantation of the MAGNITUDE® Bioresorbable Arterial Scaffold DEVICE

Placement of one or more MAGNITUDE® bioresorbable scaffolds using a percutaneous technique at one or more arterial stenoses.

MAGNITUDE® Scaffold

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥ 18 years and ≤ 90 years of age.
• Subject agrees not to participate in any other investigational device or drug study for a period of at least six months following the index procedure. Questionnaire-based studies, or other studies that are non-invasive and do not require investigational devices or medications are allowed.
• Subject (or their legally authorized representative) provides written informed consent prior to any study-related procedure, using the form approved by the local Ethics Committee.
• Subject has lifestyle limiting claudication or chronic limb threatening ischemia (Rutherford-Becker categories 3 - 5).
• Subject agrees to complete all protocol required follow-up visits, including angiograms.
• Subject has suitable common femoral (contralateral or antegrade ipsilateral) vascular access. (Note: Radial or pedal access not allowed.)
• Subject has up to three de novo or restenotic native infrapopliteal lesions with \> 70% stenosis by angiography.
• Lesion(s) must be located in the proximal 2/3 of native infrapopliteal vessels and at least 10 cm above the tibio-talar joint.
• Reference vessel(s) diameter of 2.5 - 3.5 mm by IVUS.
• A maximum of three 18 mm scaffolds, or one 38 mm scaffold, or one 18 mm length scaffold with one 38 mm length scaffold can be implanted per patient.
• Scaffold(s) must cover at least 2 mm from the pre-dilatation borders, resulting in a maximum allowed lesion length of:
• mm for a single 18 mm length scaffold
• mm for two overlapping 18 mm length scaffolds (using the marker overlap technique)
• mm for three overlapping 18 mm length scaffolds (using the marker overlap technique)
• mm for a single 38 mm length scaffold

You may not qualify if:

• Pregnant or nursing subjects and those who plan pregnancy within 6 months following index procedure. (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.)
• Presence of other significant comorbid conditions, or other medical, social, or psychological conditions (such as history of substance {alcohol, cocaine, heroin, etc.} abuse), that in the investigator's opinion may limit the subject's ability to participate or comply with study instructions and follow-up (includes subjects with symptomatic COVID-19 infection in the past 2 months or asymptomatic COVID-19 positive test in the past 1 month).
• Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority to control their activities.
• Life expectancy of \< 1 year.
• Subject is non-ambulatory.
• Subject has prior major amputation (either limb).
• Subject has chronic renal insufficiency stage 4 or above or requires dialysis.
• 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 with planned surgery or procedure necessitating discontinuation of antiplatelet medications within 6 months after the index procedure.
• Subject has active systemic infection.
• Subject has a prior stroke or MI within 3 months of the index procedure.
• 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 is receiving immunosuppression therapy and/or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, rheumatoid arthritis, severe asthma requiring immunosuppressive medication, etc.).
• Subject has active malignancy (receiving or scheduled to receive anticancer therapy for malignancy within 1 year prior to or after the index procedure), active blood dyscrasia or coagulation disorder (platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC \< 3,000 cells/mm3, or hemoglobin \< 8.0 g/dl).
• Subject with uncontrolled diabetes with HbA1c \> 10%.

Sponsors & Collaborators

• R3 Vascular Inc.: lead
• Massachusetts General Physicians Organization / Vascore: collaborator
• Cardiovascular Research Foundation, New York: collaborator

Study Sites (7)

Medical University Graz

Graz, Austria

RECRUITING

CRCHUM Université Montreal

Montreal, Canada

RECRUITING

Hopital Saint-Francois d'Assise

Québec, Canada

ACTIVE NOT RECRUITING

Toronto General Hospital

Toronto, Canada

RECRUITING

San Donato Hospital

Arezzo, Italy

RECRUITING

Maria Cecilia Hospital

Cotignola, Italy

RECRUITING

IRCCS Multimedica

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan F Granada, MD

  Cardiovascular Research Foundation (CRF)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew J Ford, Jr.

CONTACT

650-537-4145; aford@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 will receive the investigational device

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: June 3, 2021
• Study Start: August 17, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2031
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); AU (1); IT (3)