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Compares treatment options for Coronary Disease
Official title The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial
ClinicalTrials.gov ID: NCT05346068
What this study is testing
- What it's testing
- Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation has become the dominant treatment strategy for patients with acute and chronic coronary artery disease (CAD) requiring revascularization. Nonetheless, PCI with stent implantation has some limitations and especially patients with severely calcified coronary lesions (approximately 10-20% of all patients with CAD) have an elevated risk for adverse outcomes, including target lesion failure (TLF) and stent thrombosis (ST).
- 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
- Clinical
- 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...
- Angiographically-proven coronary artery disease;
- Lesions in non-target vessels requiring PCI may be treated either
You likely can't join if
- 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;
See the full eligibility criteria
Who can join
- Clinical
- 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
- 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...
- 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 assigned by chance patient may be treated according to protocol and considered for the purpose...
What rules you out
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Lucerne, Switzerland
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 Lucerne, Switzerland. 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.