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NCT02673697 · ClinicalTrials.gov registry record · NA
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
A NA study, sponsored by Corcym S.r.l.
- Terminated
- Registry status
- NA
- Development phase
- 914
- Enrollment target
NCT02673697: Clinical Trial NA study, sponsored by Corcym S.r.l.
NCT02673697 is a NA study that was terminated before completion, run by Corcym S.r.l. The registered enrollment target is 914 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02673697, a NA study, was terminated before completion, sponsored by Corcym S.r.l.
- TERMINATED
- Registry status
- NA
- Development phase
- 914 participants
- Enrollment target
Study Summary
Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively. The trial will enroll up to 1234 subjects, but accrual may stop earlier at approximately 900 or 1050 subjects These subjects will be enrolled at approximately 60 worldwide investigational sites where the device is commercially available The primary objective of this trial is to test the safety and efficacy of Perceval versus standard sutured stented bioprosthetic aortic valves among the intended trial population.
Primary Outcome
The primary endpoint is freedom from MACCE (composite endpoint of all cause death, myocardial infarction, stroke, and valve re-intervention) at one year based on Clinical Event Committee (CEC) adjudication.
Interventions
- DEVICE Perceval valve
- DEVICE other stented biological valve
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 914 participants |
| Start Date | 2016-03-22 |
| Est. Completion | 2020-07-31 |
| Phase | NA |
Why NCT02673697 stopped before completion
NCT02673697 is an interventional study that assigns participants to a tested intervention. The registered 914 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 (35% lower).
The record links to 0 conditions, and to 2 interventions - of which Perceval valve is the first listed.
NCT02673697 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02673697 about?
NCT02673697 is a clinical study titled "Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement". Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively. The trial will enroll up to 1234 subjects, but accrual may stop earlier at approximately 900 o...
What is the current status of trial NCT02673697?
This trial is currently terminated. It is a NA study. The enrollment target is 914 participants. The study started on 2016-03-22. Estimated completion is 2020-07-31.
What interventions are being tested in trial NCT02673697?
The interventions under investigation include: Perceval valve (DEVICE), other stented biological valve (DEVICE).
Who is sponsoring clinical trial NCT02673697?
This trial is sponsored by Corcym S.r.l, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02673697's enrollment target sits among peer trials
914 124th of 2000 higher than 1,877 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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