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New treatment option for Coronary Artery Disease
Official title Virtue® SAB in the Treatment of Coronary ISR Trial
ClinicalTrials.gov ID: NCT07045194
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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.
- people 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...
- Target lesion is located within a saphenous vein graft or an arterial graft.
See the full eligibility 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.
- 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.
- people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Roslyn, New York, United States
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roslyn, New York, United States; Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.