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RECRUITING NA

Virtue® SAB in the Treatment of Coronary ISR Trial

NCT07045194 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 740 participants
Start Date 2025-10-20
Est. Completion 2032-10
Phase NA

Sponsor

Orchestra BioMed

2 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 740 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Orchestra BioMed, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07045194 reports 2 study locations spanning 2 distinct geographic areas — top geographies include New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07045194?

The interventions under investigation include: Virtue Sirolimus AngioInfusion Balloon (DEVICE), AGENT™ Paclitaxel Drug-Coated Balloon (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07045194?

This trial is sponsored by Orchestra BioMed, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial