NCT07045194ClinicalTrials.gov

Virtue® SAB in the Treatment of Coronary ISR 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).

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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).

Interventionell740 Teilnehmende gesucht15 Studienzentren1 Land

Kategorien

Herz-Kreislauf100%

In 1 Register registriert

ClinicalTrials.govNCT07045194Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Monaten

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2025-07-01; recorded start 2025-10-20
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 1 other study in this databaseCounted from the lead sponsor named in the record (Orchestra BioMed, Inc)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding7/20
Single-blind
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 15 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study: 740 participants (target), run at 15 sites.

How this score is built

Enrolment28/40
740 participants (target)
Site count14/25
15 sites
Country count0/15
Single country
Planned duration10/10
Planned over about 85 months
Sponsor scale1/10
Orchestra BioMed, Inc has led 2 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Zusammenfassung

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).

Erkrankungen

Coronary Artery Disease

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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.

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Nicht zutreffend
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	SINGLE (1)
Teilnahme	740 Teilnehmende gesucht

Sponsor und Mitwirkende

Orchestra BioMed, Inc Sponsor

Studienarme und Interventionen

Virtue SABEXPERIMENTAL
Coronary PCI, Sirolimus AngioInfusion Balloon (SAB)
AGENT™ DCBACTIVE_COMPARATOR
Coronary Angioplasty, AGENT™ Paclitaxel Drug-Coated Balloon (DCB)

Interventionen

Medizinprodukt AGENT™ Paclitaxel Drug-Coated Balloon
Percutaneous Coronary Intervention
Medizinprodukt Virtue Sirolimus AngioInfusion Balloon
Percutaneous Coronary Intervention

Endpunkte

Primärer Endpunkt
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)
Zeitrahmen 12 months
Sekundärer Endpunkt
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.
Zeitrahmen 12 months

Daten

Daten
Startdatum	20. Oktober 2025 (tatsächlich)
Primärer Abschluss	1. Oktober 2028 (geschätzt)
Abschluss	1. Oktober 2032 (geschätzt)
Erstveröffentlichung	1. Juli 2025 (tatsächlich)
Zuletzt aktualisiert	23. Juli 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	Juli 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

15 Studienzentren rekrutieren

United States

United States
Einrichtung	Stadt	Bundesland oder Region	Status
Mission Hospital	Asheville	North Carolina	Rekrutiert
Ascension Saint Agnes Heart Care	Baltimore	Maryland	Rekrutiert
The Lindner Center for Research at Christ Hospital	Cincinnati	Ohio	Rekrutiert
The Cardiac and Vascular Institute	Gainesville	Florida	Rekrutiert
Ascension St. Vincent	Indianapolis	Indiana	Rekrutiert
Ascension Seton Hays	Kyle	Texas	Rekrutiert
Ascension Columbia St. Mary's Hospital	Milwaukee	Wisconsin	Rekrutiert
TriStar Centennial Medical Center	Nashville	Tennessee	Rekrutiert
Ascension St. Thomas Hospital	Nashville	Tennessee	Rekrutiert
Ascension Sacred Heart	Pensacola	Florida	Rekrutiert
Thomas Jefferson University	Philadelphia	Pennsylvania	Rekrutiert
St. Francis Hospital	Roslyn	New York	Rekrutiert
Corewell Health William Beaumont University Hospital	Royal Oak	Michigan	Rekrutiert
Ascension Via Christi Saint Francis	Wichita	Kansas	Rekrutiert
WellSpan Health	York	Pennsylvania	Rekrutiert

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

https://xmedica.io/trials/ctgov/NCT07045194