300 Participants Needed

Sirolimus-Eluting Scaffold for Critical Limb Ischemia

(ELITE-BTK Trial)

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JB
MH
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Overseen ByJosh Smale
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: R3 Vascular Inc.
Must be taking: Antiplatelet medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

What is the purpose of this trial?

The objective of this prospective, single-blinded, randomized controlled trial is to evaluate the safety and efficacy of the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions. Approximately 276 subjects will be randomized in a 1:1 ratio. The clinical investigation will be conducted at up to 60 clinical sites globally.

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 data supports the effectiveness of the treatment MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold for Critical Limb Ischemia?

Research on similar treatments, like the Absorb bioresorbable vascular scaffold, shows promising results for treating limb-threatening ischemia, with high rates of keeping arteries open and low rates of major amputation over 24 months. This suggests that the MAGNITUDE scaffold, which uses a similar approach, may also be effective.12345

Is the Sirolimus-Eluting Scaffold generally safe for humans?

The safety of the Sirolimus-Eluting Scaffold, also known as the MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold, has been studied in animals, showing promising healing responses. However, similar bioresorbable scaffolds have been associated with a higher risk of blood clots compared to metallic stents in some studies.12567

What makes the MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold treatment unique for critical limb ischemia?

The MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold is unique because it is a thin-strut, bioresorbable scaffold that releases sirolimus, a drug that helps prevent artery blockage, and is designed to dissolve over time, reducing long-term complications associated with permanent stents.12358

Research Team

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Eric Secemsky, MD

Principal Investigator

Beth Israel Deaconess Medical Center

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Marianne Brodmann, MD

Principal Investigator

Medical University of Graz

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Ramon L Varcoe, MD

Principal Investigator

Prince of Wales Private Hospital

Eligibility Criteria

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.
See 16 more

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.
See 29 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: MAGNITUDE BRSExperimental Treatment1 Intervention
Participants who receive the MAGNITUDE BRS device will be included in this arm
Group II: Percutaneous Transluminal Angioplasty (PTA)Active Control1 Intervention
Participants who receive a PTA device will be included in this arm

Find a Clinic Near You

Who Is Running the Clinical Trial?

R3 Vascular Inc.

Lead Sponsor

Trials
3
Recruited
360+

Findings from Research

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.
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 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.
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]
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.
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]

References

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. [2020]
Single arm retrospective study of bioresorbable vascular scaffolds to treat patients with severe infrapopliteal arterial disease. [2020]
Long-term performance and biocompatibility of a novel bioresorbable scaffold for peripheral arteries: A three-year pilot study in Yucatan miniswine. [2020]
Mid-term outcomes of an everolimus-eluting bioresorbable vascular scaffold in patients with below-the-knee arterial disease: A pooled analysis of individual patient data. [2022]
Novel ultrahigh molecular weight amorphous PLLA bioresorbable coronary scaffold upsized up to 0.8 mm beyond nominal diameter: An OCT and histopathology study in porcine coronary artery model. [2019]
Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. [2022]
Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents. [2017]
Two-year longitudinal evaluation of a second-generation thin-strut sirolimus-eluting bioresorbable coronary scaffold with hybrid cell design in porcine coronary arteries. [2022]
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