Virtue® SAB in the Treatment of Coronary ISR Trial
Purpose
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).
Condition
- Coronary Artery Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Virtue SAB |
Coronary PCI, Sirolimus AngioInfusion Balloon (SAB) |
|
|
Active Comparator AGENT™ DCB |
Coronary Angioplasty, AGENT™ Paclitaxel Drug-Coated Balloon (DCB) |
|
Recruiting Locations
The Cardiac and Vascular Institute
Gainesville, Florida 32605
Gainesville, Florida 32605
Contact:
Carissa Fertil
Carissa Fertil
Ascension Sacred Heart
Pensacola, Florida 32504
Pensacola, Florida 32504
Contact:
Jessica Flores
Jessica Flores
Ascension St. Vincent
Indianapolis, Indiana 46290
Indianapolis, Indiana 46290
Contact:
Jessica Green
Jessica Green
Ascension Via Christi Saint Francis
Wichita, Kansas 67214
Wichita, Kansas 67214
Contact:
Kristen Thomas
Kristen Thomas
Ascension Saint Agnes Heart Care
Baltimore, Maryland 21229
Baltimore, Maryland 21229
Contact:
Heather T Blubaugh
Heather T Blubaugh
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan 48073
Royal Oak, Michigan 48073
Contact:
Rachel Wylie
Rachel Wylie
St. Francis Hospital
Roslyn, New York 11576
Roslyn, New York 11576
Contact:
E Haag
E Haag
Mission Hospital
Asheville, North Carolina 28801
Asheville, North Carolina 28801
Contact:
Grace Raegan
Grace Raegan
The Lindner Center for Research at Christ Hospital
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Contact:
T Buchtmann
T Buchtmann
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Contact:
Elizabeth Robinson
Elizabeth Robinson
WellSpan Health
York, Pennsylvania 17403
York, Pennsylvania 17403
Contact:
Lori Slenker
Lori Slenker
TriStar Centennial Medical Center
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Contact:
Amara Howard
Amara Howard
Ascension St. Thomas Hospital
Nashville, Tennessee 37236
Nashville, Tennessee 37236
Contact:
Peiman Nebi
Peiman Nebi
Ascension Seton Hays
Kyle, Texas 78640
Kyle, Texas 78640
Contact:
Abigail Alvarado
Abigail Alvarado
Ascension Columbia St. Mary's Hospital
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
Contact:
Stephenee Supan
Stephenee Supan
More Details
- Status
- Recruiting
- Sponsor
- Orchestra BioMed, Inc
Detailed Description
The Virtue® ISR trial is a prospective, multi-center, single-blind, randomized (1:1), non-inferiority study. The Virtue® Sirolimus AngioInfusion™ Balloon (SAB) will be compared to the AGENT Paclitaxel Drug-Coated Balloon (DCB) in the treatment of coronary artery in-stent restenosis (ISR).