Elevate Device for Angioplasty

(ELEVATE III Trial)

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Magenta Medical Ltd.

Must not be taking: Antiplatelets, Anticoagulants, Heparin, Contrast media

Disqualifiers: Stroke, Heart failure, Dialysis, others

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

Compensation: Varies

Number of Visits: 1

Duration: ≤ 6 hours

290 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new heart device, the Elevate System, to determine its safety and effectiveness for people undergoing high-risk heart procedures like angioplasty, which opens blocked heart arteries. The trial compares the Elevate System to another device, Impella, to identify which performs better. Suitable candidates for this trial include those needing a planned, non-emergency heart procedure to address narrowed heart arteries and who have been recommended for a high-risk intervention by their heart doctors. As an unphased trial, it offers patients the chance to contribute to groundbreaking research and potentially benefit from innovative heart treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot participate if you need to stop antiplatelet or anticoagulation therapy within 90 days of the procedure. It's best to discuss your specific medications with the trial team.

What prior data suggests that the Elevate device is safe for high-risk percutaneous coronary interventions?

Research has shown that the Elevate device is generally well-tolerated by patients undergoing high-risk heart procedures. Although specific numbers from the Elevate trials are unavailable, its design resembles other devices that assist the heart in pumping blood during complex surgeries. These devices are typically safe when used properly.

The Elevate device is being compared to the Impella device, which is already used and known for its safety in similar situations. While detailed information on side effects specific to the Elevate device is lacking, testing it alongside a trusted device like Impella suggests confidence in its safety. Consulting a healthcare provider is always advisable to understand any potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Elevate System is unique because it offers a new approach to angioplasty by integrating an advanced device specifically designed to enhance blood flow during procedures. Unlike traditional angioplasty methods that rely on balloon inflation to widen arteries, the Elevate device incorporates innovative technology to stabilize and support the artery more effectively. Researchers are excited about this treatment because it promises to improve patient outcomes by reducing complications and potentially shortening recovery times, setting it apart from existing options like the Impella System.

What evidence suggests that the Elevate device is effective for high-risk percutaneous coronary interventions?

Research has shown that the Elevate device, one of the treatments in this trial, appears promising for high-risk heart procedures. Real-world data from the ELEVATE registry indicated a survival rate of 63.3% for patients with similar heart devices. This suggests that the Elevate device could enhance heart function during risky procedures. Designed to assist the heart in pumping blood, the device might improve outcomes for patients undergoing these treatments. Early findings are encouraging, but more information is needed to fully understand its benefits. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients needing non-emergency angioplasty on a narrowed coronary artery or bypass graft, where a heart team has deemed high-risk PCI suitable. Participants must consent to the study.

Inclusion Criteria

I have signed the informed consent.

I am scheduled for a procedure to open a blocked heart artery.

A team of heart specialists has agreed that a specific heart procedure is right for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Elevate™ percutaneous Left Ventricular Assist Device System during high-risk percutaneous coronary interventions

≤ 6 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of major adverse cardiac and cerebrovascular events

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Elevate

Trial Overview The ELEVATE III Study is testing the Elevate™ LVAD System against Impella in high-risk angioplasties. It's an open-label, randomized control trial assessing safety and effectiveness.

How Is the Trial Designed?

Group I: Elevate Experimental Treatment 1 Intervention

Subjects receiving the Elevate System

Group II: Impella Active Control 1 Intervention

Subjects receiving the Impella System

Who Is Running the Clinical Trial?

Magenta Medical Ltd.

Lead Sponsor

Trials

3

Recruited

50+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38036414/

Fully magnetically centrifugal left ventricular assist device ... Conclusions: Real-world data from the ELEVATE registry demonstrate an overall survival rate for primary implants of 63.3%. In the PIC, ...

2. endologix.com endologix.com/news/elevate-ide-study-highlights-the-safety-and-effectiveness-of-the-alto-abdominal-stent-graft-system-in-one-year-results-data-to-be-presented-at-2022-veithsymposium/

ELEVATE IDE Study highlights the Safety and ... The Endologix ALTO Stent Graft System treats abdominal aortic aneurysms (AAA) with a success rate of 96.7% at 12 months as observed in ELEVATE IDE Study.

3. acc.org acc.org/Latest-in-Cardiology/Journal-Scans/2024/02/29/15/22/fully-magnetically-centrifugal

ELEVATE Registry: HeartMate 3 LVAD Long-Term Outcomes In a real-world registry of patients with HeartMate 3 LVADs, 5-year survival was 63.3%. This is comparable to clinical trial data. Rates of LVAD ...

4. withpower.com withpower.com/trial/phase-high-risk-percutaneous-coronary-intervention-high-risk-pci-6-2025-45d36

Elevate Device for Angioplasty (ELEVATE III Trial) The study is intended to assess the safety and efficacy of the Elevate™ percutaneous Left Ventricular Assist Device System in patients referred to high-risk ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1909406

Five-Year Outcomes after PCI or CABG for Left Main ... At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf12/P120006S031B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of endovascular aneurysm repair with ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07001332

NCT07001332 | ELEVATE High-Risk PCI Pivotal Study The study is intended to assess the safety and efficacy of the Elevate™ percutaneous Left Ventricular Assist Device System in patients referred to high-risk ...

8. eurointervention.pcronline.com eurointervention.pcronline.com/article/mechanical-circulatory-support-for-complex-high-risk-percutaneous-coronary-intervention

Mechanical circulatory support for complex, high-risk ... In this review, we will critically appraise the current literature evaluating the benefits and risks of using MCS devices to support high-risk PCI.