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VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)
NCT06132568 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06132568
The ClinicalTrials.gov registry entry for NCT06132568 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 120 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06132568 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Massachusetts, Georgia, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06132568?
The interventions under investigation include: VITALYST System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06132568?
This trial is sponsored by Boston Scientific Corporation, which has 120 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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