Virtue® SAB in the Treatment of Coronary ISR Trial
Public ClinicalTrials.gov record NCT07045194. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT07045194
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 740 participants
Conditions and interventions
Conditions
Interventions
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 19, 2025
- Primary completion
- Sep 30, 2028
- Completion
- Sep 30, 2032
- Last update posted
- Jul 22, 2026
2025 – 2032
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Cardiac and Vascular Institute | Gainesville | Florida | 32605 | Recruiting |
| Ascension Sacred Heart | Pensacola | Florida | 32504 | Recruiting |
| Ascension St. Vincent | Indianapolis | Indiana | 46290 | Recruiting |
| Ascension Via Christi Saint Francis | Wichita | Kansas | 67214 | Recruiting |
| Ascension Saint Agnes Heart Care | Baltimore | Maryland | 21229 | Recruiting |
| Corewell Health William Beaumont University Hospital | Royal Oak | Michigan | 48073 | Recruiting |
| St. Francis Hospital | Roslyn | New York | 11576 | Recruiting |
| Mission Hospital | Asheville | North Carolina | 28801 | Recruiting |
| The Lindner Center for Research at Christ Hospital | Cincinnati | Ohio | 45219 | Recruiting |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | Recruiting |
| WellSpan Health | York | Pennsylvania | 17403 | Recruiting |
| TriStar Centennial Medical Center | Nashville | Tennessee | 37203 | Recruiting |
| Ascension St. Thomas Hospital | Nashville | Tennessee | 37236 | Recruiting |
| Ascension Seton Hays | Kyle | Texas | 78640 | Recruiting |
| Ascension Columbia St. Mary's Hospital | Milwaukee | Wisconsin | 53226 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07045194, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 22, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07045194 live on ClinicalTrials.gov.