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.
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).
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.
Single group
Percutaneous Implantation of the MAGNITUDE® Bioresorbable Arterial Scaffold
DevicePlacement of one or more MAGNITUDE® bioresorbable scaffolds using a percutaneous technique at one or more arterial stenoses.
(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")
(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
Technical Success
Defined as delivery and deployment of the scaffold to the target lesion resulting in a final angiographic in-lesion percent diameter stenosis ≤ 30%
Procedural Success
Defined as Technical Success without procedural Major Adverse Event (which includes thrombosis, distal embolization, or vessel rupture)
Angiographic Acute Gain
Defined as the difference between the post- and pre-procedural minimal lumen diameter within the scaffold and within the scaffolded vessel segment as assessed by angiography
Angiographic Late Lumen Loss
Defined as the difference between the post-procedural and follow-up minimal lumen diameter within the scaffold and within the scaffolded vessel segment as assessed by angiography
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R3 Vascular Inc.
Lead sponsor
Massachusetts General Physicians Organization / Vascore
Collaborator
Cardiovascular Research Foundation, New York
Collaborator
