Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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 has a reference vessel diameter ≥ 2.0 mm and ≤ 4.0 mm by visual assessment.

The subject has only one critical ISR lesion in the target vessel.

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

Design model

Parallel

Treatments tested in this trial

  • Virtue Sirolimus AngioInfusion Balloon

    Device

    Percutaneous Coronary Intervention

  • AGENT™ Paclitaxel Drug-Coated Balloon

    Device

    Percutaneous Coronary Intervention

Treatment groups

740 Participants
are divided into 2 treatment groups
Group A: Virtue SABExperimental treatment 1 intervention
Group B: AGENT™ DCBActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Target Lesion Failure (TLF) at 12 months

Defined as a composite of cardiac death (CD), non-fatal target vessel myocardial infarction (MI) SCAI definition, and ischema-driven target lesion revascularization (TLR)

Time frame
12 months

Secondary outcomes

1

Target Lesion Failure (TLF) Comparison at 12 months

Target Lesion Failure (TLF) at 12 months of subjects treated with Virtue® SAB compared to a PBA Performance Goal.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Orchestra BioMed, Inc

Lead sponsor

Source ClinicalTrials.gov
Apply now