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NCT04985773 · ClinicalTrials.gov registry record · NA
A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon
A NA study, sponsored by Infraredx.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
NCT04985773: Completed NA study, sponsored by Infraredx.
NCT04985773 is a NA study that has completed, run by Infraredx. The registered enrollment target is 200 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04985773, a NA study, has completed, sponsored by Infraredx.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate safety and effectiveness of the Lacrosse NSE ALPHA coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.
Primary Outcome
Defined as: * Successful delivery, inflation, deflation, and withdrawal of the study balloon; and * No evidence of device-related vessel perforation, flow limiting dissection (grade C or higher per Clinical Events Committee (CEC) adjudication) or reduction in thrombolysis in myocardial infarction (TIMI) flow from baseline (per core laboratory assessment); and * Final TIMI flow grade of 3 at the conclusion of the PCI procedure per core laboratory assessment. This endpoint will be presented as t
Interventions
- DEVICE Lacrosse NSE ALPHA coronary dilatation catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-12-17 |
| Est. Completion | 2022-12-16 |
| Phase | NA |
What the finished NCT04985773 record still lists
NCT04985773 is an interventional study that assigns participants to a tested intervention. The registered 200 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 (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Lacrosse NSE ALPHA coronary dilatation catheter is the first listed.
NCT04985773 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04985773 about?
NCT04985773 is a clinical study titled "A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon". The objective of this study is to evaluate safety and effectiveness of the Lacrosse NSE ALPHA coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.
What is the current status of trial NCT04985773?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2021-12-17. Estimated completion is 2022-12-16.
What interventions are being tested in trial NCT04985773?
The interventions under investigation include: Lacrosse NSE ALPHA coronary dilatation catheter (DEVICE).
Who is sponsoring clinical trial NCT04985773?
This trial is sponsored by Infraredx, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04985773's enrollment target sits among peer trials
200 506th of 2000 higher than 1,434 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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