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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 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).
* 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 it's running

• Banner University Medical Center Phoenix
  Phoenix, Arizona, United States Recruiting
• The Cardiac and Vascular Institute
  Gainesville, Florida, United States Recruiting
• Memorial Regional Hospital
  Hollywood, Florida, United States Recruiting
• Ascension Sacred Heart
  Pensacola, Florida, United States Recruiting
• Emory University Hospital
  Atlanta, Georgia, United States Recruiting
• Ascension St. Vincent
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Dean Kereiakes, MD — Lindner Center for Research at Christ Hospital
• Study coordinator: Hans-Peter Stoll, MD, PHD
• Email: hpstoll@orchestrabiomed.com
• Phone: 646-956-2161

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.