ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2

Launched by DEUTSCHES HERZZENTRUM MUENCHEN · Sep 28, 2021

Keywords

ClinConnect Summary

The ISAR-CALC 2 trial is a research study designed to find out which method works better for treating severely calcified coronary artery disease—using a very high-pressure balloon or a special technique called intravascular lithotripsy (IVL). Both methods are used to prepare the artery before placing a drug-eluting stent, which helps keep the artery open. The goal of the trial is to see how well each method improves the size of the artery after treatment.

To participate in this trial, individuals need to be at least 18 years old and able to give consent. They should be experiencing ongoing chest pain despite medication or have signs of reduced blood flow to the heart. Eligible participants will have a new lesion (blockage) in their heart's arteries that is severely calcified. If you choose to participate, you can expect to receive one of the two treatment methods and will be closely monitored for outcomes. It's important to note that individuals with certain conditions, such as previous heart surgery or other serious health issues, may not be eligible for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age above 18 years and able to give consent
• • Persistent angina despite medical therapy and/or evidence of inducible ischemia
• • De-novo lesion in a native coronary artery
• • Target reference vessel diameter or intended stent diameter ≥2.50 or ≤4.00 mm by visual estimation
• • Severe calcification of the target lesion as determined by visual estimation at coronary angiography
• • Unsuccessful lesion preparation with standard non-compliant balloon (\< 30% reduction of baseline diameter stenosis at maximal pressure)
• • Written informed consent.
• Exclusion Criteria:
• • Target lesion is located in a coronary artery bypass graft
• • Target lesion is an in-stent restenosis
• • Target lesion is a chronic total occlusion
• • Target vessel thrombus
• • Limited long-term prognosis due to other comorbid conditions with life expectancy \<12 months