Clinical 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).
NCT07045194 is registered in ClinicalTrials.gov with Orchestra BioMed, Inc as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- 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).
- Lead sponsor
- Orchestra BioMed, Inc
- Phase
- Not applicable
- Overall status
- Recruiting
- Start date
- October 20, 2025
- Completion date
- October 31, 2032
- Enrollment
- 740 (estimated)
- Sites
- 15
Conditions
As the registry lists them; a condition with its own page is linked.