Comparing methods for treating severely calcified coronary lesions
Super High-Pressure Balloon Versus Intravascular Lithotripsy for Severely Calcified Coronary Lesions: The ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions (ISAR-CALC) 2 Randomized Trial
This study is testing whether using a super high-pressure balloon or a special sound wave treatment works better for preparing hard-to-treat blocked arteries before putting in a stent.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Deutsches Herzzentrum Muenchen Academic / other |
| Locations | 4 sites (Bad Oeynhausen and 3 other locations) |
| Trial ID | NCT05072730 on ClinicalTrials.gov |
What this trial studies
The ISAR-CALC 2 trial investigates the effectiveness of two different strategies for preparing severely calcified coronary lesions prior to drug-eluting stent implantation. Participants will be randomly assigned to receive either a super high-pressure balloon or intravascular lithotripsy. The primary outcome measure is the final angiographic minimal lumen diameter achieved after the intervention. This multicenter trial aims to provide insights into which method yields better results for patients with calcified coronary artery disease.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with persistent angina and severe calcification of a de-novo coronary lesion.
Not a fit: Patients with lesions in bypass grafts, in-stent restenosis, chronic total occlusions, or limited life expectancy due to other comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for patients with severely calcified coronary lesions.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bad Oeynhausen and 3 other locations
- Herz- und Diabeteszentrum NRW Universitätsklinikum der Ruhr-Universität Bochum — Bad Oeynhausen, Germany (Recruiting)
- Universitätsklinikum Frankfurt — Frankfurt am Main, Germany (Recruiting)
- MEDICLIN Herzzentrum Lahr — Lahr, Germany (Recruiting)
- Deutsches Herzzentrum Muenchen — Muenchen, Germany (Recruiting)
Study contacts
- Principal investigator: Salvatore Cassese, MD, PhD — Deutsches Herzzentrum Munich
- Study coordinator: Tobias Rheude, MD
- Email: rheude@dhm.mhn.de
- Phone: +49 89 1218 2985
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.