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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: Recruiting NA study of Coronary Artery Disease, sponsored by Orchestra BioMed.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Defined as a composite of cardiac death (CD), non-fatal target vessel myocardial infarction (MI) SCAI definition, and ischema-driven target lesion revascularization (TLR)
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 |
What NCT07045194 shows while recruiting
NCT07045194 is an interventional study that assigns participants to a tested intervention. The registered 740 participants enrollment target is mid-sized for trials with a published cap, below the 1,284-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (42% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Coronary Artery Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07045194's enrollment target sits among peer trials
740 60th of 219 higher than 160 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease 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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