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NCT07001332 · ClinicalTrials.gov registry record · NA
ELEVATE High-Risk PCI Pivotal Study
A NA study of High-Risk Percutaneous Coronary Intervention (High-risk PCI), sponsored by Magenta Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 290
- Enrollment target
- 20
- Study locations
NCT07001332: Recruiting NA study of High-Risk Percutaneous Coronary Intervention (High-risk PCI), sponsored by Magenta Medical.
NCT07001332 is a NA study of High-Risk Percutaneous Coronary Intervention (High-risk PCI) that is actively recruiting participants, run by Magenta Medical. The registered enrollment target is 290 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07001332, a NA study of High-Risk Percutaneous Coronary Intervention (High-risk PCI), is actively recruiting participants, sponsored by Magenta Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 290 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
A composite of the incidence of: 1. Major Adverse Cardiac and Cerebrovascular Events (MACCE): Death, Myocardial Infarction, Stroke or Transient Ischemic Attack, Unplanned Repeat Revascularization; 2. Major intra-procedural hemodynamic events on Mechanical Circulatory Support: Severe Hypotension, Cardio-Pulmonary Resuscitation or Cardioversion; 3. Major Mechanical Circulatory Support-related access site complications: Vascular Injury Requiring Intervention or Access Site Bleeding.
Conditions Studied
Interventions
- DEVICE Impella
- DEVICE Elevate
Study Locations (20)
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham & Women's Hospital - Boston
- Boston Medical Center - Boston
- Beth Israel Deaconess Medical Center - Boston
- UMass Memorial Medical Center - Worcester
New York
- Northwell- South Shore University Hospital - Bay Shore
- Maimonides Health - Brooklyn
- Buffalo General Medical Center - Buffalo
- North Shore University Hospital - Manhasset
New Jersey
- Atlantic Health System - Morristown
- Robert Wood Johnson University Hospital - New Brunswick
Arizona
- HonorHealth Scottsdale Shea Medical Center - Scottsdale
California
- University of California at San Francisco Medical Center - San Francisco
Florida
- Tampa General/USF - Tampa
Georgia
- Wellstar Health System - Marietta
Illinois
- University of Chicago Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2025-07-25 |
| Est. Completion | 2027-09-16 |
| Phase | NA |
What NCT07001332 shows while recruiting
NCT07001332 is an interventional study that assigns participants to a tested intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).
The record links to 1 condition, with High-Risk Percutaneous Coronary Intervention (High-risk PCI) appearing as the primary indexed condition, and to 2 interventions - of which Impella is the first listed.
NCT07001332 names 20 study sites across 12 states, led by Massachusetts, New York, New Jersey.
Frequently Asked Questions
What is clinical trial NCT07001332 about?
NCT07001332 is a clinical study titled "ELEVATE High-Risk PCI Pivotal Study". 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...
What is the current status of trial NCT07001332?
This trial is currently recruiting. It is a NA study. The enrollment target is 290 participants. The study started on 2025-07-25. Estimated completion is 2027-09-16.
What conditions does trial NCT07001332 study?
This clinical trial studies the following conditions: High-Risk Percutaneous Coronary Intervention (High-risk PCI).
What interventions are being tested in trial NCT07001332?
The interventions under investigation include: Impella (DEVICE), Elevate (DEVICE).
Who is sponsoring clinical trial NCT07001332?
This trial is sponsored by Magenta Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07001332 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07001332's enrollment target sits among peer trials
290 375th of 2000 higher than 1,625 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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