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Bioresorbable Scaffold

Bioresorbable Arterial Scaffold for Peripheral Artery Disease (RESOLV I Trial)

N/A
Recruiting
Led By Juan F Granada, MD
Research Sponsored by R3 Vascular Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject agrees to complete all protocol required follow-up visits, including angiograms
At least one fully patent below-the-ankle artery (i.e., dorsalis pedis; common, lateral, or medial plantar arteries) without hemodynamically significant lesions (≥ 50% diameter stenosis by angiography) must be present in the target limb
Must not have
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 has chronic renal insufficiency stage 4 or above or requires dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 1, 3, 6, and 12 months (post implantation procedure)
Awards & highlights

Summary

This trial will evaluate the safety and performance of the R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffold in patients with PAD. The scaffold is made of a polymer material that will dissolve over time. Patients will be assessed over the course of five years to evaluate the success of the treatment.

Who is the study for?
This trial is for adults aged 18-90 with severe peripheral arterial disease, causing leg pain or risk of limb amputation. Participants must have specific types of blockages in their lower leg arteries and agree to follow-up visits over five years. Pregnant individuals, those with recent major cardiovascular events, uncontrolled diabetes, known allergies to device materials or study medications, prior below-the-knee bypasses or stents in the target vessel are excluded.Check my eligibility
What is being tested?
The trial tests a new MAGNITUDE® Bioresorbable Drug-Eluting Scaffold designed to dissolve over time after improving blood flow in the lower leg's diseased artery. This first-in-human study aims to alleviate symptoms and reduce amputation risks by comparing it against standard care for up to three treated vascular blockages.See study design
What are the potential side effects?
Potential side effects may include local reactions at the implant site such as pain or infection, allergic reactions to scaffold materials or drugs used during treatment, issues related to dissolving material like inflammation or blockage if fragments dislodge before complete absorption.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to attend all required follow-up visits and tests.
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I have at least one open artery below my ankle without major blockages.
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My most distant lesion was crossed with a wire for treatment.
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I have up to three new or recurring blockages in my lower leg arteries.
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I have severe leg pain or risk of losing my limb due to poor blood flow.
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Any blockages in my leg above the knee have been treated.
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I am between 18 and 90 years old.
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My lesion is in the upper part of my lower leg's vessels, away from the ankle.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently being treated for cancer or have a blood disorder.
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I have severe kidney problems or am on dialysis.
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I have severe foot problems, including bone infection or gangrene.
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I have an aneurysm or a recent clot in my aorta or leg arteries.
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I have had a bypass surgery below the knee on the affected limb.
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I had a procedure to improve blood flow in a specific blood vessel within the last 3 months.
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My treatment involves supporting both branches of a bifurcated lesion.
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My lesions cannot be opened with initial treatment.
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I am on immunosuppression therapy or have an autoimmune disease.
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I currently have an infection that affects my whole body.
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I am not incapacitated and can make my own decisions.
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I cannot walk by myself.
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My diabetes is not under control, with an HbA1c level over 10%.
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I have had a major limb amputation.
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I am allergic to certain materials or medications used in the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at 1, 6, and 12 months (post implantation procedure)
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 1, 6, and 12 months (post implantation procedure) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
(Performance) Primary Patency of the Target Lesion(s)
(Safety) Freedom from MALE and POD
Secondary outcome measures
All-Cause Death
Angiographic Acute Gain
Angiographic Binary Restenosis
+9 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: MAGNITUDE® ScaffoldExperimental Treatment1 Intervention
Subject with up to three study lesions treated by implanting a maximum of 3 R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffolds

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Peripheral Arterial Disease (PAD) include lifestyle modifications, pharmacotherapy, and revascularization procedures. Lifestyle changes such as smoking cessation and exercise improve blood flow and reduce symptoms. Pharmacotherapy often involves antiplatelet agents to prevent blood clots and statins to manage cholesterol levels. Revascularization procedures, including angioplasty and stenting, physically open narrowed arteries. The R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffold represents an advanced revascularization technique. It temporarily supports the artery to restore blood flow and delivers drugs to prevent restenosis, then gradually dissolves, reducing long-term complications associated with permanent stents. This is crucial for PAD patients as it aims to improve blood flow, alleviate symptoms, and minimize the risk of future arterial blockages.
New Innovations in Drug-Eluting Stents for Peripheral Arterial Disease.Bioresorbable scaffolds: a new paradigm in percutaneous coronary intervention.Current status of bioresorbable scaffolds in the treatment of coronary artery disease.

Find a Location

Who is running the clinical trial?

Cardiovascular Research Foundation Clinical Trials CenterUNKNOWN
Massachusetts General Physicians Organization / VascoreUNKNOWN
Cardiovascular Research Foundation, New YorkOTHER
25 Previous Clinical Trials
27,171 Total Patients Enrolled

Media Library

MAGNITUDE® Bioresorbable Arterial Scaffold (Bioresorbable Scaffold) Clinical Trial Eligibility Overview. Trial Name: NCT04912323 — N/A
Peripheral Arterial Disease Research Study Groups: MAGNITUDE® Scaffold
Peripheral Arterial Disease Clinical Trial 2023: MAGNITUDE® Bioresorbable Arterial Scaffold Highlights & Side Effects. Trial Name: NCT04912323 — N/A
MAGNITUDE® Bioresorbable Arterial Scaffold (Bioresorbable Scaffold) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04912323 — N/A
~14 spots leftby Dec 2026