Actively Recruiting
The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial
Led by Luzerner Kantonsspital · Updated on 2024-06-18
280
Participants Needed
1
Research Sites
288 weeks
Total Duration
On this page
Sponsors
L
Luzerner Kantonsspital
Lead Sponsor
H
Hôpital Fribourgeois
Collaborating Sponsor
AI-Summary
What this Trial Is About
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). Several dedicated PCI devices have been developed for treatment of severely calcified lesions. Whereas especially two of them have shown promising results in smaller, prospective studies. First, the super high-pressure NC PCI balloon (OPN™ NC, SIS Medical AG, Frauenfeld, Switzerland) has been shown to represent an effective and safe device for lesion preparation. Second, the lately introduced Shockwave intravascular lithotripsy (IVL)™ balloon catheter (Shockwave Medical, Santa Clara, CA, USA) appears to be a safe and efficient alternative device for treatment of calcified coronary lesions. However, it remains unknown, if the OPN™ NC balloon is non-inferior to to IVL regarding lesion preparation and completeness of stent expansion in severely calcified lesions.
CONDITIONS
Official Title
The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and able to give consent
- Acute or chronic coronary artery disease with symptoms of ischemia or evidence of myocardial ischemia
- Angiographically confirmed coronary artery disease
- Lesions in non-target vessels requiring PCI may be treated either before the study procedure if unsuccessful or complicated, or in the same session if safe; otherwise staged PCI may be considered
- Signed informed consent
- Single de novo target lesion in protected left main coronary artery, LAD, RCA, LCX, or their branches with stenosis of 70% or more, or 50% to less than 70% with evidence of ischemia or low fractional flow reserve or low instantaneous wave-free ratio or small lumen area by imaging
- Target vessel diameter between 2.5 mm and 4.5 mm
- Evidence of calcification at the lesion site by angiography (Grade 3), with radio-opacities involving both sides of the arterial wall and calcium length at least 15 mm, and/or by OCT with at least 270° calcium, and/or prior unsuccessful PCI balloon expansion attempt
- Only one lesion and vessel per patient to be treated, representing the most calcified lesion
You will not qualify if you...
- Acute STEMI or cardiogenic shock related to acute myocardial infarction within 2 days before the procedure
- Any condition reducing compliance with the protocol or follow-up, including advanced dementia
- Medical, geographic, or social factors making participation or follow-up impractical
- Pregnancy or nursing (negative pregnancy test required for women of child-bearing potential)
- Unable to take P2Y12 inhibitors for at least 6 months
- Allergy to imaging contrast media that cannot be pre-medicated
- Renal failure with eGFR less than 30 ml/min/1.73m2
- Stroke or transient ischemic attack within 7 days, or any prior intracranial hemorrhage
- Active peptic ulcer or upper gastrointestinal bleeding within 6 months
- Untreated hemoglobin less than 10 g/dL or refusal of blood transfusions if needed
- Allergy or intolerance to cobalt-chromium or everolimus
- Life expectancy less than 1 year
- Anatomy preventing delivery of device or OCT catheter due to tortuosity or other features
- Target lesion in a coronary artery bypass graft
- Target lesion is an in-stent restenosis
- Flow limiting thrombus in target vessel
- Definite or possible thrombus in target vessel
- Aneurysm within 10 mm of target lesion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Luzerner Heart Centre
Lucerne, Switzerland, 6000
Actively Recruiting
Research Team
F
Florim Cuculi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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