What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Peripheral Arterial Disease (PAD), such as bioresorbable drug-eluting scaffolds, can have side effects including restenosis (re-narrowing of the artery), thrombosis (blood clot formation), and local inflammatory reactions. Other treatments like drug-eluting stents may also cause similar issues, along with potential allergic reactions to the drug coating. Antithrombotic therapies, often used in conjunction with these devices, can increase the risk of bleeding complications. It is important to monitor for these side effects and manage them in consultation with a healthcare provider.

What other types of research exist?

Promising alternatives to the R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffold for PAD patients include: 1) Drug-coated balloons (DCBs) which deliver antiproliferative drugs to the arterial wall to prevent restenosis without leaving a permanent implant. 2) Newer generations of bioresorbable scaffolds that offer improved mechanical properties and drug delivery capabilities. 3) Advanced endovascular techniques such as atherectomy combined with drug delivery systems to remove plaque and deliver medication directly to the arterial wall. These alternatives are being actively researched and have shown potential in clinical trials.

← Back to Search

Bioresorbable Scaffold

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

Q: What prior FDA approvals exist?

The FDA has approved various treatments for Peripheral Arterial Disease (PAD), including drug-eluting stents and balloon angioplasty. However, bioresorbable scaffolds, which provide temporary support to the artery and then dissolve over time, are a newer area of investigation. The R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffold is an example of such an innovative approach, aiming to restore blood flow and reduce the risk of limb amputation. While bioresorbable scaffolds have been used in coronary arteries, their application in lower extremity arteries is still under clinical evaluation, as seen in the RESOLV I study.

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

No Placebo-Only Group

Summary

This trial tests a new dissolvable stent for patients with severe leg artery blockages. The stent helps improve blood flow, releases medicine to prevent re-blockage, and then dissolves gradually. This could reduce pain and lower the risk of amputation. Bioabsorbable stents have been extensively evaluated in coronary artery disease but remain challenging and less studied in lower extremities.

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.

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.

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

Select...

I agree to attend all required follow-up visits and tests.

Select...

I have at least one open artery below my ankle without major blockages.

Select...

My most distant lesion was crossed with a wire for treatment.

Select...

I have up to three new or recurring blockages in my lower leg arteries.

Select...

I have severe leg pain or risk of losing my limb due to poor blood flow.

Select...

Any blockages in my leg above the knee have been treated.

Select...

I am between 18 and 90 years old.

Select...

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:

Select...

I am currently being treated for cancer or have a blood disorder.

Select...

I have severe kidney problems or am on dialysis.

Select...

I have severe foot problems, including bone infection or gangrene.

Select...

I have an aneurysm or a recent clot in my aorta or leg arteries.

Select...

I have had a bypass surgery below the knee on the affected limb.

Select...

I had a procedure to improve blood flow in a specific blood vessel within the last 3 months.

Select...

My treatment involves supporting both branches of a bifurcated lesion.

Select...

My lesions cannot be opened with initial treatment.

Select...

I am on immunosuppression therapy or have an autoimmune disease.

Select...

I currently have an infection that affects my whole body.

Select...

I am not incapacitated and can make my own decisions.

Select...

I cannot walk by myself.

Select...

My diabetes is not under control, with an HbA1c level over 10%.

Select...

I have had a major limb amputation.

Select...

I am allergic to certain materials or medications used in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at 1, 6, and 12 months (post implantation procedure)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

(Safety) Freedom from MALE and POD

Secondary study objectives

All-Cause Death

Angiographic Acute Gain

Angiographic Binary Restenosis

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 23Eligibility criteria met

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.