Sirolimus AngioInfusion Balloon versus Paclitaxel Drug-Coated Balloon for coronary in-stent restenosis

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).

This study will test whether the Virtue sirolimus angioinfusion balloon works as well as the AGENT paclitaxel drug-coated balloon for people with a single coronary in‑stent restenosis lesion.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 740 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Orchestra BioMed, Inc (Industry-sponsored)
• Locations: 2 sites (Roslyn, New York and 1 other locations)
• Trial ID: NCT07045194 on ClinicalTrials.gov

What this trial studies

This is a prospective, multi-center, single-blind, randomized (1:1) non-inferiority trial comparing the Virtue Sirolimus AngioInfusion Balloon (SAB) to the AGENT Paclitaxel Drug-Coated Balloon (DCB) for treatment of coronary artery in-stent restenosis (ISR). Eligible participants have a single critical ISR lesion in a native coronary artery (one or two stent layers) with vessel diameter 2.0–4.0 mm and lesion length ≤26 mm. Subjects are randomized to receive either the sirolimus angioinfusion balloon or the paclitaxel-coated balloon and followed for clinical outcomes. The trial tests whether clinical outcomes with the Virtue SAB are non-inferior to those with the AGENT DCB.

Who should consider this trial

Good fit: Ideal candidates are adults with a single coronary in‑stent restenosis lesion (one or two stent layers) in a 2.0–4.0 mm vessel, lesion length ≤26 mm, and prior treatment with a DES or BMS.

Not a fit: Patients with lesion length >26 mm, vessel diameter <2.0 mm or >4.0 mm, multiple critical ISR lesions, or other exclusions are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the Virtue sirolimus balloon could provide an alternative drug-delivery option that matches current paclitaxel-coated balloons in preventing restenosis.

How similar studies have performed: Paclitaxel-coated balloons have established benefit for coronary ISR, while sirolimus-coated delivery technologies are newer and show early promising but less mature evidence.

Eligibility criteria

Inclusion Criteria:

* 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).
* Target lesion length must be ≤ 26 mm and must be completely coverable by only one Virtue® or AGENT™ balloon. The balloon can extend up to 5 mm proximal or distal beyond the edge of the target stented length.
* The target lesion must have one of the following:
* Visually estimated stenosis of ≥ 70% and \<100% diameter stenosis, OR
* Visually estimated stenosis ≥ 50% and \< 70% with one of the following:
* abnormal fractional flow reserve (FFR) including Angio based FFR ≤ 0.80, or;
* abnormal instantaneous wave-free ratio (iFR) or resting full-cycle ratio (RFR) ≤ 0.89, or;
* abnormal stress or imaging stress test, or;
* ischemic symptoms referable to the target lesion
* Involved in a NSTEMI or Acute Coronary Syndrome (ACS) event with decreasing enzymes
* Target lesion must be successfully pre-treated according to standard of care with an achieved residual stenosis of ≤ 30% by visual estimate with TIMI grade flow of 3 prior to randomization.

Exclusion Criteria:

* 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.
* If single-layer ISR, any previous treatment (other than balloon angioplasty alone) of the target vessel for restenosis. If double-layer ISR, any treatment (other than balloon angioplasty alone) of the double-layer ISR restenosis.
* Target lesion is located within a saphenous vein graft or an arterial graft.
* Thrombus is present in the target vessel.
* \> 50% stenosis of an additional lesion proximal or clinically significant distal (\>2.0mm RVD) to the target lesion.
* A dissection in the target lesion requiring treatment with a stent post pre-dilatation.
* The target ISR lesion has more than two layers of previously placed stents.
* Subject has critical unprotected left main coronary artery disease.

Where this trial is running

Roslyn, New York and 1 other locations

• St. Francis Hospital — Roslyn, New York, United States (Recruiting)
• The Lindner Center for Research at Christ Hospital — Cincinnati, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Dean Kereiakes, MD — Lindner Center for Research at Christ Hospital
• Study coordinator: Hans-Peter Stoll, MD, PHD

Conditions Coronary Artery Disease; In-Stent Restenosis