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NCT07045194 · ClinicalTrials.gov registry record · NA
Virtue® SAB in the Treatment of Coronary ISR Trial
A NA study of Coronary Artery Disease, sponsored by Orchestra BioMed.
- Recruiting
- Registry status
- NA
- Development phase
- 740
- Enrollment target
- 2
- Study locations
NCT07045194 is a NA study of Coronary Artery Disease that is actively recruiting participants, run by Orchestra BioMed. The registered enrollment target is 740 participants, below the 1,284-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (42% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT07045194, a NA study of Coronary Artery Disease, is actively recruiting participants, sponsored by Orchestra BioMed.
- RECRUITING
- Registry status
- NA
- Development phase
- 740 participants
- Enrollment target
- 2
- Study locations
Study Summary
A prospective, multi-center, single-blind, randomized (1:1), non-inferiority study comparing clinical outcomes of the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) to the AGENT™ Paclitaxel Drug-Coated Balloon (DCB) in the treatment of coronary artery in-stent restenosis (ISR).
Conditions Studied
Interventions
- DEVICE Virtue Sirolimus AngioInfusion Balloon
- DEVICE AGENT™ Paclitaxel Drug-Coated Balloon
Study Locations (2)
New York
- St. Francis Hospital - Roslyn
Ohio
- The Lindner Center for Research at Christ Hospital - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 740 participants |
| Start Date | 2025-10-20 |
| Est. Completion | 2032-10 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07045194
The ClinicalTrials.gov registry entry for NCT07045194 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 740 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,284-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (42% lower). The listed sponsor is Orchestra BioMed, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Virtue Sirolimus AngioInfusion Balloon is the first listed.
NCT07045194 reports 2 study locations spanning 2 distinct geographic areas - top geographies include New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT07045194 about?
NCT07045194 is a clinical study titled "Virtue® SAB in the Treatment of Coronary ISR Trial". A prospective, multi-center, single-blind, randomized (1:1), non-inferiority study comparing clinical outcomes of the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) to the AGENT™ Paclitaxel Drug-Coated Balloon (DCB) in the treatment of coronary artery in-stent restenosis (ISR).
What is the current status of trial NCT07045194?
This trial is currently recruiting. It is a NA study. The enrollment target is 740 participants. The study started on 2025-10-20. Estimated completion is 2032-10.
What conditions does trial NCT07045194 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT07045194?
The interventions under investigation include: Virtue Sirolimus AngioInfusion Balloon (DEVICE), AGENT™ Paclitaxel Drug-Coated Balloon (DEVICE).
Who is sponsoring clinical trial NCT07045194?
This trial is sponsored by Orchestra BioMed, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07045194 being conducted?
This trial has 2 study locations across New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.