Trials / Recruiting
RecruitingNCT07001332
ELEVATE High-Risk PCI Pivotal Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 290 (estimated)
- Sponsor
- Magenta Medical Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 88 Years
- Healthy volunteers
- Not accepted
Summary
The ELEVATE III Pivotal Study is a prospective, multi-center, open-label, interventional, randomized, controlled study with an active control group. 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 percutaneous coronary interventions (HR-PCI).
Detailed description
The Elevate™ percutaneous Left Ventricular Assist Device System is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (HR-PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease. Use of the Elevate™ System in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Elevate | The Elevate System is a catheter- mounted, self-expanding and retrievable, continuous-flow pump, designed to unload the left ventricle by actively transporting blood from the left ventricle into the ascending aorta, thus augmenting cardiac output and maintaining systemic arterial pressure during complex/high-risk coronary interventions. Subjects will receive an Elevate prior to their high-risk percutaneous intervention. |
| DEVICE | Impella | Subjects will receive an Impella prior to their high-risk percutaneous intervention. |
Timeline
- Start date
- 2025-07-25
- Primary completion
- 2027-03-16
- Completion
- 2027-09-16
- First posted
- 2025-06-03
- Last updated
- 2026-03-17
Locations
28 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07001332. Inclusion in this directory is not an endorsement.