Comparing two methods for treating severely calcified coronary lesions

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

This study tests two different devices to see which one works better for preparing tough, calcified heart arteries before putting in a stent for people with coronary artery disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Luzerner Kantonsspital (Academic / other)
• Locations: 1 site (Lucerne)
• Trial ID: NCT05346068 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of two different devices for preparing severely calcified coronary lesions before stent implantation in patients with coronary artery disease. Participants will be randomly assigned to receive treatment with either the Shockwave intravascular lithotripsy (IVL) balloon or the super high-pressure non-compliant (NC) balloon. The study aims to assess the final stent expansion and safety outcomes associated with each device. Follow-up assessments will occur at 30 days, 1 year, and 2 years post-procedure to monitor patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with chronic or acute coronary artery disease and severely calcified lesions requiring percutaneous coronary intervention.

Not a fit: Patients with non-calcified coronary lesions or those who do not require stenting may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients with heavily calcified coronary lesions, reducing the risk of complications.

How similar studies have performed: Previous smaller studies have shown promising results for both devices being tested, indicating potential for success in this trial.

Eligibility criteria

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 mm²;
* 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.

Where this trial is running

Lucerne

• Luzerner Heart Centre — Lucerne, Switzerland (Recruiting)

Study contacts

• Study coordinator: Florim Cuculi, MD

Conditions Coronary Disease; Coronary Artery Disease; Calcific Coronary Arteriosclerosis; Stent Restenosis; Coronary Artery Calcification