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NCT03647475 · ClinicalTrials.gov registry record · NA
A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)
A NA study, sponsored by Medtronic Vascular.
- Completed
- Registry status
- NA
- Development phase
- 752
- Enrollment target
NCT03647475: Completed NA study, sponsored by Medtronic Vascular.
NCT03647475 is a NA study that has completed, run by Medtronic Vascular. The registered enrollment target is 752 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03647475, a NA study, has completed, sponsored by Medtronic Vascular.
- COMPLETED
- Registry status
- NA
- Development phase
- 752 participants
- Enrollment target
Study Summary
The purpose of this trial is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.
Primary Outcome
Composite of cardiac death and myocardial infarction at one year for a one-month clear population \[Time Frame: One month to one year\]
Interventions
- COMBINATION_PRODUCT Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 752 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2021-04-22 |
| Phase | NA |
What the finished NCT03647475 record still lists
NCT03647475 is an interventional study that assigns participants to a tested intervention. The registered 752 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 (46% lower).
The record links to 0 conditions, and to 1 intervention - of which Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT is the first listed.
NCT03647475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03647475 about?
NCT03647475 is a clinical study titled "A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)". The purpose of this trial is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.
What is the current status of trial NCT03647475?
This trial is currently completed. It is a NA study. The enrollment target is 752 participants. The study started on 2018-10-01. Estimated completion is 2021-04-22.
What interventions are being tested in trial NCT03647475?
The interventions under investigation include: Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03647475?
This trial is sponsored by Medtronic Vascular, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03647475's enrollment target sits among peer trials
752 145th of 2000 higher than 1,856 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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