Comparative study of two different balloon catheters (IVL balloon and OPN high-pressure balloon) used to prepare severely calcified coronary arteries for stent implantation (VICTORY study)

Switzerland (ICTRP)

Identifiant de l'essai ICTRP
NCT05346068 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
The Value of IVL Compared To OPN Non-Compliant ßalloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial - A randomized, multicenter, non-inferiority comparison of Shockwave lntravascular Lithotripsy (IVL) and the OPN non compliant balloon for treatment of calcified and refractory coronary lesions (BASEC)

Titre académique
The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial - A Randomized, Multicenter, Non-inferiority Comparison of Shockwave Intravascular Lithotripsy (IVL) and the OPN Non-compliant Balloon for Treatment of Calcified and Refractory Coronary Lesions (ICTRP)

Titre public
The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial (ICTRP)

Maladie en cours d'investigation
Coronary Disease;Coronary Artery Disease;Calcific Coronary Arteriosclerosis;Stent Restenosis;Coronary Artery Calcification (ICTRP)

Intervention étudiée
Device: OPN? NCB Super High Pressure PCI Balloon;Device: Shockwave? C2 IVL Catheter (ICTRP)

Type d'essai
Interventional (ICTRP)

Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)

Critères d'inclusion/exclusion
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Clinical inclusion criteria:

- Age =18 years and consentable;

- Acute or chronic coronary artery disease with ischemia related symptoms (e.g.
angina) and/or evidence of myocardial ischemia (e.g. FFR/ iFR, CMR, SPECT or
PET-CT);

- Angiographically-proven coronary artery disease;

- Lesions in non-target vessels requiring PCI may be treated either

- prior to the study procedure if the procedure was unsuccessful or complicated;
or

- in the same session if feasible and safe for the patient, otherwise a staged
PCI procedure for non-target vessels may be considered;

- Informed Consent signed by the subject.

Angiographic inclusion criteria:

- Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of
their branches) with*:

- Stenosis of =70%;

- Stenosis =50% and <70% (visually assessed) with evidence of ischemia via
positive stress test, or fractional flow reserve value =0.80, or iFR <0.90 or
IVUS minimum lumen area =4.0 mm?;

- The target vessel reference diameter must be =2.5 mm & =4.5mm;

- AND AT LEAST ONE OF THE FOLLOWING CRITERIA:

- Evidence of calcification at the lesion site by angiography (Grade 3), with
fluoroscopic radio-opacities noted without cardiac motion prior to contrast
injection involving both sides of the arterial wall in at least one location
and total length of calcium of at least 15 mm and extending partially into the
target lesion,

- AND/ OR by OCT, with presence of =270? calcium;

- AND/ OR Prior attempt at PCI with inability to expand a balloon in target
lesion.

Annotation: Only one lesion and vessel per randomized patient may be treated according to
protocol and considered for the purpose of this study. The lesion considered for the
study should represent the most calcified one.

The presence of any one of the following exclusion criteria will lead to the exclusion of
the subject:

Exclusion criteria:

- Patient experienced an acute STEMI or cardiogenic shock related to an acute MI
within 2 days prior to index procedure;

- Any comorbidity or condition which may reduce compliance with this protocol,
including follow-up calls/ visits (e.g. advanced dementia);

- Any medical, geographic, and/or social factor making study participation impractical
or precluding required follow-up.

- Patient is pregnant or nursing (a negative pregnancy test is required for women of
child-bearing potential within 7 days prior to enrollment);

- Unable to take a P2Y12 inhibitor (i.e. clopidogrel, prasugrel, or ticagrelor) for at
least 6 months;

- Patient has an allergy to imaging contrast media which cannot be adequately
pre-medicated;

- Renal failure with an eGFR <30ml/min1.73m2;

- History of a stroke or transient ischemic attack (TIA) within 7 days, or any prior
intracranial hemorrhage;

- Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months;

- Untreated pre-procedural hemoglobin <10g/dL or intention to refuse blood
transfusions if one should become necessary;

- Patient has an allergy or intolerance to cobalt-chromium and/ or everolimus.

- Life expectancy of less than 1 year.

Angiographic exclusion criteria:

- Anatomy where the device or OCT catheter are unlikely to be delivered due to
tortuosity or other characteristics;

- Target lesion is in a coronary artery bypass graft;

- Target lesion is an in-stent restenosis (ISR);

- Flow limiting target vessel thrombus (evident on angiography or OCT);

- Definite or possible thrombus (by angiography or intravascular imaging) in the
target vessel;

- Evidence of aneurysm in target vessel within 10 mm of the target lesion.

Of note, only qualified physicians who are investigators or a sub-investigators for the
trial will assess each individual?s eligibility criteria and take the final decision to
include the subject in the trial (ICH GCP 4.3.1). This decision will be documented prior
to the subject receiving the first intervention. (ICTRP)

non disponible

Critères d'évaluation principaux et secondaires
Final stent expansion (in percentage, %) assessed by OCT (ICTRP)

Acceptable stent expansion (>80%) assessed by OCT;Optimal stent expansion (>90%) assessed by OCT;Procedural success;Strategy success (ICTRP)

Date d'enregistrement
non disponible

Inclusion du premier participant
non disponible

Sponsors secondaires
H?pital Fribourgeois;Hamilton General Hospital (ICTRP)

Contacts supplémentaires
Florim Cuculi, MD;Florim Cuculi, MD, florim.cuculi@luks.ch, +41412052134;+41412052134 (ICTRP)

ID secondaires
VICTORY Trial (ICTRP)

Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05346068 (ICTRP)