Virtue® SAB in the Treatment of Coronary ISR Trial
ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOrchestra BioMed, Inc
About this 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).
Eligibility criteria
Qualifiers
In-stent restenosis (one or two stent layers) in a lesion previously treated with drug- eluting (DES) or bare metal stents (BMS) in a native coronary artery.
The target lesion is in a vessel with a reference vessel diameter ≥ 2.0 mm and ≤ 4.0 mm by visual assessment.
The subject has only one critical ISR lesion.
The subject may have one other critical lesion in a non-target vessel that must be treated before the Target Lesion (TL).
Disqualifiers
Subject has a left ventricular ejection fraction < 30% within 6 months.
Subject was treated by PCI or another coronary intervention within the last 30 days.
Planned PCI or CABG after the index procedure.
Subjects with STEMI < 72 hours prior to index procedure and those with NSTEMI who have increasing biomarkers within 12 hours of the index procedure.
Trial design
Treatments tested in this trial
- Virtue Sirolimus AngioInfusion Balloon
- AGENT™ Paclitaxel Drug-Coated Balloon
Treatment groups
740 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov