Sirolimus-Eluting Scaffold for Critical Limb Ischemia

(ELITE-BTK Trial)

Recruiting at 1 trial location

Overseen By Josh Smale

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: R3 Vascular Inc.

Must be taking: Antiplatelet medications

Disqualifiers: Pregnancy, Severe kidney disease, Uncontrolled diabetes, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the MAGNITUDE BRS (Sirolimus-eluting Bioresorbable Scaffold), which releases medication to treat narrowed blood vessels in the lower legs. It targets individuals with critical limb ischemia, a condition where poor blood flow causes leg pain or non-healing wounds. Participants will receive either the MAGNITUDE BRS or a standard treatment known as percutaneous transluminal angioplasty (PTA). This trial suits those experiencing serious leg pain or non-healing wounds due to poor circulation. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance treatment options for critical limb ischemia.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on antiplatelet medications, you should not have any planned surgery or procedure that requires stopping these medications within 6 months after the procedure.

What prior data suggests that the MAGNITUDE BRS System is safe for treating narrowed infrapopliteal lesions?

Research has shown that the MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold has been tested in people with encouraging safety results. Studies indicate that this scaffold, which slowly releases medicine to prevent blood vessel blockage, is generally well-tolerated.

Reports from similar scaffolds suggest that most patients experience only mild side effects, such as minor discomfort at the treatment site. Serious side effects are rare, but they can occur with any treatment.

Sirolimus, the drug used in these scaffolds, is already approved by the FDA for other uses, suggesting a certain level of safety, although each new use can have different risks.

Overall, while researchers continue to study the MAGNITUDE scaffold, current data provides some reassurance about its safety in people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MAGNITUDE Sirolimus-Eluting Bioresorbable Scaffold because it offers a novel approach to treating critical limb ischemia. Unlike traditional treatments like bare-metal stents and drug-coated balloons, this scaffold not only delivers the drug sirolimus, which helps prevent artery re-narrowing, but also gradually dissolves over time. This means it supports the artery while healing and then disappears, potentially reducing long-term complications associated with permanent implants. This bioresorbable feature is a game-changer, providing structural support temporarily and reducing the risk of future blockages or inflammation.

What evidence suggests that the MAGNITUDE BRS System is effective for critical limb ischemia?

Research has shown that the MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold, which participants in this trial may receive, holds promise for treating narrowed arteries. Studies have found that this scaffold, which releases the drug sirolimus, is both safe and effective. In earlier trials, patients who received this treatment experienced improved blood flow. Made from a special material, the scaffold slowly dissolves in the body, potentially reducing long-term complications. Initial findings suggest it could benefit those with critical limb ischemia, a serious condition that limits blood flow to the limbs. ^{2 6 7 8 9}

Who Is on the Research Team?

Eric Secemsky, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Marianne Brodmann, MD

Principal Investigator

Medical University of Graz

Ramon L Varcoe, MD

Principal Investigator

Prince of Wales Private Hospital

Are You a Good Fit for This Trial?

This trial is for adults with Critical Limb Ischemia, specifically Rutherford categories 4 or 5. Participants must have specific narrowed leg vessels treatable with the MAGNITUDE BRS System and agree to follow-up visits. Exclusions include pregnancy, life expectancy <1 year, recent major cardiovascular events, severe kidney disease, uncontrolled diabetes (HbA1c > 10%), and certain other medical conditions.

Inclusion Criteria

Subject has provided written informed consent prior to any study-related procedure, using the form approved by the Institutional Review Board / Ethics Committee

My target lesion is in the lower leg's main artery.

The arteries in my lower leg and foot are open.

Exclusion Criteria

Subject is pregnant or nursing

Estimated life expectancy <1 year

I am scheduled for surgery or a procedure within 6 months after my initial treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the MAGNITUDE BRS device or a PTA device for the treatment of narrowed infrapopliteal lesions

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of Major Adverse Limb Events and limb salvage

6 months

What Are the Treatments Tested in This Trial?

Interventions

• MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold

Trial Overview The trial tests the safety and effectiveness of the MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold compared to Percutaneous Transluminal Angioplasty in treating below-the-knee arterial blockages. It's a randomized controlled study involving about 276 subjects at up to 60 global sites.

How Is the Trial Designed?

Group I: MAGNITUDE BRS Experimental Treatment 1 Intervention

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

Group II: Percutaneous Transluminal Angioplasty (PTA) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

R3 Vascular Inc.

Lead Sponsor

Trials

3

Recruited

360+

Published Research Related to This Trial

The new thin-walled Magnitude bioresorbable scaffold (BRS) showed significantly fewer fractures during biomechanical testing compared to the Absorb BRS, indicating better structural integrity under stress.

In a study involving 22 swine, the Magnitude-BRS demonstrated superior strut coverage and lower late recoil at 14 and 28 days, suggesting enhanced vascular healing and stability compared to the Absorb scaffold.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro mechanical behavior and in vivo healing response of a novel thin-strut ultrahigh molecular weight poly-l-lactic acid sirolimus-eluting bioresorbable coronary scaffold in normal swine. Cheng, Y., Gasior, P., Ramzipoor, K., et al.[2020]

In a long-term study involving 14 bioresorbable scaffolds (BRS) implanted in the iliofemoral arteries of 7 Yucatan miniswine, the sirolimus-eluting BRS demonstrated significant improvements in lumen area over time, indicating effective vessel support and remodeling.

The study showed that the BRS had minimal inflammatory reactions and nearly complete polymer degradation by 3.3 years, suggesting a favorable safety profile and potential for long-term use without the complications associated with metallic stents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term performance and biocompatibility of a novel bioresorbable scaffold for peripheral arteries: A three-year pilot study in Yucatan miniswine. Melnick, G., Ferrone, M., Cheng, Y., et al.[2020]

In a study involving 5,583 patients followed for an average of 2 years, bioresorbable vascular scaffolds (BVS) were found to have a significantly higher risk of target lesion failure (9.6% vs. 7.2%) compared to metallic everolimus-eluting stents (EES).

BVS also showed a much higher incidence of stent thrombosis (2.4% vs. 0.7%), indicating that while both devices are used for coronary interventions, BVS may pose greater safety risks over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents. Sorrentino, S., Giustino, G., Mehran, R., et al.[2017]

In a study of 31 patients with advanced infrapopliteal peripheral artery disease (PAD), the Absorb bioresorbable vascular scaffold (BVS) demonstrated a high primary patency rate of 96.7% and a freedom from clinically driven target vessel failure (CD-TVF) of 95.1% at 12 months, indicating its efficacy in managing complex lesions.

The Absorb BVS showed a favorable safety profile, with no instances of scaffold thrombosis or significant bleeding, and all patients remained alive at the 12-month follow-up, suggesting it is a safe option for treating chronic limb ischemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single arm retrospective study of bioresorbable vascular scaffolds to treat patients with severe infrapopliteal arterial disease. Dia, A., Venturini, JM., Kalathiya, R., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04912323

Study of the R3 Vascular Drug-Eluting Bioresorbable ... This first-in-human clinical feasibility study will evaluate the safety and performance of the R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffold ...

2. evtoday.com evtoday.com/news/r3-vascular-initiates-first-in-human-study-of-magnitude-bioresorbable-sirolimus-eluting-scaffold

R3 Vascular Initiates First-In-Human Study of Magnitude ... R3 Vascular Inc. announced the initiation of its first-in-human clinical study evaluating the technical and clinical performance of the company's Magnitude ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.120.010013

RENASCENT III: First in Human Evaluation of the Novel ... The Sirolimus-Eluting Ultra-High Molecular Weight MAGNITUDE BRS demonstrated to be safe and effective in our first in man experience up to 2 ...

4. drugdeliverybusiness.com drugdeliverybusiness.com/r3-first-patient-drug-eluting-scaffold-study/

R3 reports first patient in next-gen drug-eluting scaffold study Made from a unique, ultra-high molecular-weight polylactic acid polymer, Magnitude could address chronic limb-threatening ischemia (CLTI).

5. sciencedirect.com sciencedirect.com/science/article/pii/S2949912723000144

Nonsystematic review of drug-eluting resorbable scaffolds ... This review presents the unique properties of drug-eluting resorbable scaffolds (DRS), and lessons learned from their use to date.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06071429

Bioresorbable Sirolimus-Eluting Scaffold Treatment for ... The objective of this prospective, single-blinded, randomized controlled trial is to evaluate the safety and efficacy of the MAGNITUDE BRS System for the ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04912323

Study of the R3 Vascular Drug-Eluting Bioresorbable ... This first-in-human clinical feasibility study will evaluate the safety and performance of the R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffold ...

8. withpower.com withpower.com/trial/phase-chronic-limb-threatening-ischemia-2-2024-44b70

Sirolimus-Eluting Scaffold for Critical Limb Ischemia The objective of this prospective, single-blinded, randomized controlled trial is to evaluate the safety and efficacy of the MAGNITUDE BRS System for the ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11264025/

Bioresorbable Scaffolds for Below-the-Knee Arterial Disease Safety and efficacy of the novel sirolimus-eluting bioresorbable scaffold ... Critical Limb Ischemia: 12-Month Results. Vascular Disease Management . 2005 ...