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NCT06132568 · ClinicalTrials.gov registry record · NA
VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)
A NA study of High-risk Percutaneous Coronary Intervention and Heart Disease, Coronary, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 5
- Study locations
NCT06132568: Completed NA study of High-risk Percutaneous Coronary Intervention and Heart Disease, Coronary, sponsored by Boston Scientific Corporation.
NCT06132568 is a NA study of High-risk Percutaneous Coronary Intervention and Heart Disease, Coronary that has completed, run by Boston Scientific Corporation. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06132568, a NA study of High-risk Percutaneous Coronary Intervention and Heart Disease, Coronary, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 5
- Study locations
Study Summary
The VITALYST Early Feasibility study (EFS) is designed to evaluate the feasibility and safety of the VITALYST System in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).
Primary Outcome
The primary endpoint consists of the composite endpoint of Clinical Success \[measured through 72 hours or hospital discharge (whichever comes first)\], which is defined as follows. * Technical Success: Successful delivery of the device to the correct anatomical position; and Successful operation and removal of the VITALYST circulatory support system * Absence of termination of revascularization procedure due to hemodynamic concern, or escalation to ECMO or other more intensive mechanical circu
Conditions Studied
Interventions
- DEVICE VITALYST System
Study Locations (5)
Massachusetts
- Brigham and Women's Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
Georgia
- Piedmont Heart Institute - Atlanta
New York
- Columbia University Medical Center/New York Presbyterian Hospital - New York
Other
- Skane University Hospital - Lund
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-05-09 |
| Est. Completion | 2025-01-17 |
| Phase | NA |
What the finished NCT06132568 record still lists
NCT06132568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with High-risk Percutaneous Coronary Intervention appearing as the primary indexed condition, and to 1 intervention - of which VITALYST System is the first listed.
NCT06132568 lists 5 locations in 4 states (Massachusetts, Georgia, New York).
Frequently Asked Questions
What is clinical trial NCT06132568 about?
NCT06132568 is a clinical study titled "VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)". The VITALYST Early Feasibility study (EFS) is designed to evaluate the feasibility and safety of the VITALYST System in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).
What is the current status of trial NCT06132568?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2024-05-09. Estimated completion is 2025-01-17.
What conditions does trial NCT06132568 study?
This clinical trial studies the following conditions: High-risk Percutaneous Coronary Intervention, Heart Disease, Coronary.
What interventions are being tested in trial NCT06132568?
The interventions under investigation include: VITALYST System (DEVICE).
Who is sponsoring clinical trial NCT06132568?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06132568 being conducted?
This trial has 5 study locations across Georgia, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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