An interventional study of Super High Pressure Balloon (OPN NC) and Intravascular lithotripsy (IVL) in Calcified Coronary Artery Disease, sponsored by Deutsches Herzzentrum Muenchen. Completed at 6 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Deutsches Herzzentrum Muenchen · Not applicable, Interventional, and Treatment
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.
Detailed information is provided elsewhere.
Deutsches Herzzentrum Muenchen is the lead sponsor of 112 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be treated with a Super High Pressure percutaneous transluminal coronary angioplasty (PTCA) Balloon (OPN NC).
Device: Super High Pressure Balloon (OPN NC)
Patients will be treated with intravascular lithotripsy (IVL).
Device: Intravascular lithotripsy (IVL)
Strategy of super high-pressure balloon angioplasty after unsuccessful lesion preparation with conventional NC balloon angioplasty. Optical coherence tomography (OCT) imaging will be performed after lesion preparation with OPN balloon. Optional additional pre-dilatation with OPN/standard NC balloon is permitted at the operator´s discretion. Following lesion preparation, stenting will be performed in the same setting using a latest-generation everolimus-eluting stent (XIENCE; Abbott Vascular, Chicago, IL, USA). Optional post-dilatation with OPN balloon or standard NC balloon is permitted at the operator´s discretion.
Strategy of IVL after unsuccessful lesion preparation with conventional NC balloon angioplasty. Optical coherence tomography (OCT) imaging will be performed after lesion preparation with IVL balloon. Optional additional pre-dilatation with standard NC balloon is permitted at the operator´s discretion. Following lesion preparation, stenting will be performed in the same setting using a latest-generation everolimus-eluting stent (XIENCE; Abbott Vascular, Chicago, IL, USA). Optional post-dilatation with standard NC balloon is permitted at the operator´s discretion.
Final angiographic minimal lumen diameter
The primary outcome measure of the trial is the final angiographic minimal lumen diameter as assessed by angiographic core laboratory.
Time frame: Intraprocedural.
Angiographic Success
Defined as target lesion residual angiographic stenosis \< 30% in the presence of Thrombolysis in Myocardial Infarction (TIMI) 3 flow.
Time frame: Intraprocedural.
Procedural Success
Defined as angiographic success without the occurrence of major adverse cardiac event (MACE), a composite of cardiac death, target-vessel related MI and repeat target-vessel revascularization, during index hospitalization.
Time frame: During index hospitalization, assessed up to 30 days.
Strategy Success
Defined as procedural success using the assigned study device and DES, without requirement for additional devices for lesion preparation; i.e. rotational atherectomy
Time frame: Intraprocedural.
Acute lumen gain
Defined as minimal lumen diameter (MLD) after balloon angioplasty with the assigned study devices minus baseline MLD.
Time frame: Intraprocedural.
Complementary lesion preparation
Need for complementary lesion preparation with rotational atherectomy
Time frame: Intraprocedural.
MACE rates
Occurrence of major adverse cardiac event (MACE) up to 30 days.
Time frame: 30 days.
Stent expansion as assessed by OCT imaging.
Stent expansion index, defined as minimum stent area divided by mean reference lumen area assessed with OCT imaging.
Time frame: Intraprocedural.
Cost-effectiveness analysis
Cost-effectiveness analysis of OPN versus IVL in severely calcified coronary lesions treated with DES implantation.
Time frame: Intraprocedural.
Plan to share: No
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Deutsches Herzzentrum Muenchen