NCT05072730Completed
ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2
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
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
The ISAR-CALC 2 trial is an investigator-initiated, prospective, randomized, multicenter, assessors-blind, open-label other clinical investigation. The objective of this trial is to investigate final angiographic minimal lumen diameter (MLD) following a strategy of super high-pressure balloon (OPN NC) versus intravascular lithotripsy (IVL) for drug-eluting stent (DES) implantation in severely calcified coronary lesions.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 18 Jun 2021
- Start date
- 1 Dec 2022
- Primary completion date
- 21 May 2026
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Diseases
- Coronary artery disease
- NCT number
- NCT05072730
What you commit to
- Study type: Interventional
- Participants enrolled: 80
- From 1 Dec 2022 to the primary completion date, 21 May 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Limited long-term prognosis due to other comorbid conditions with life expectancy \<12 months
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Herz- und Diabeteszentrum NRW Universitätsklinikum der Ruhr-Universität Bochum Coordinator of this site? Confirm its status | Bad Oeynhausen | Germany | Unknown status |
| Helios Klinikum Erfurt Coordinator of this site? Confirm its status | Erfurt | Germany | Unknown status |
| Universitätsklinikum Frankfurt Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Unknown status |
| Universitätsklinikum Jena Coordinator of this site? Confirm its status | Jena | Germany | Unknown status |
| MediClin Herzzentrum Lahr Coordinator of this site? Confirm its status | Lahr | Germany | Unknown status |
| Deutsches Herzzentrum Muenchen Coordinator of this site? Confirm its status | München | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.