Calcified Coronary Artery DiseaseISAR-CALC2NCT05072730
ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2
A study testing Super High Pressure Balloon (OPN NC) and Intravascular lithotripsy (IVL) in people with Calcified Coronary Artery Disease, run by Deutsches Herzzentrum Muenchen at 6 sites in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcified Coronary Artery Disease
- What is being tested?
- Super High Pressure Balloon (OPN NC) and Intravascular lithotripsy (IVL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 6 sitesGermany
- Study dates
- 1 Dec 2022to 21 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Herz- und Diabeteszentrum NRW Universitätsklinikum der Ruhr-Universität Bochum
Bad Oeynhausen
Helios Klinikum Erfurt
Erfurt, 99089
Universitätsklinikum Frankfurt
Frankfurt am Main
Universitätsklinikum Jena
Jena, 07747
MEDICLIN Herzzentrum Lahr
Lahr, 77933
Deutsches Herzzentrum Muenchen
München
About this study
Official title: 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
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.
Read the detailed description
Detailed information is provided elsewhere.
- Conditions
- Calcified Coronary Artery Disease
- Being tested
- Super High Pressure Balloon (OPN NC), Intravascular lithotripsy (IVL)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super High Pressure Balloon (OPN NC)Device
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.
Intravascular lithotripsy (IVL)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Super high-pressure balloon (OPN NC) | Experimental | Patients will be treated with a Super High Pressure percutaneous transluminal coronary angioplasty (PTCA) Balloon (OPN NC). Receives: Device: Super High Pressure Balloon (OPN NC) |
| Intravascular lithotripsy (IVL) | Experimental | Patients will be treated with intravascular lithotripsy (IVL). Receives: Device: Intravascular lithotripsy (IVL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraprocedural.
Secondary outcomes (8)
Angiographic Success
Defined as target lesion residual angiographic stenosis < 30% in the presence of Thrombolysis in Myocardial Infarction (TIMI) 3 flow.
Measured: 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.
Measured: 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
Measured: Intraprocedural.
Acute lumen gain
Defined as minimal lumen diameter (MLD) after balloon angioplasty with the assigned study devices minus baseline MLD.
Measured: Intraprocedural.
Complementary lesion preparation
Need for complementary lesion preparation with rotational atherectomy
Measured: Intraprocedural.
MACE rates
Occurrence of major adverse cardiac event (MACE) up to 30 days.
Measured: 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.
Measured: Intraprocedural.
Cost-effectiveness analysis
Cost-effectiveness analysis of OPN versus IVL in severely calcified coronary lesions treated with DES implantation.
Measured: Intraprocedural.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start1 Dec 2022
- Primary completion21 May 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Calcified Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices, SIS Medical AG
- Responsible party
- Sponsor
- Investigators
- Salvatore Cassese, MD, PhD, Principal investigator, Deutsches Herzzentrum MunichTobias Rheude, MD, Principal investigator, Deutsches Herzzentrum Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072730
- Sponsor's protocol ID
- GE IDE Nr. BA00421
- Acronym
- ISAR-CALC2
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2021
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scalamogna M, Abdel-Wahab M, Mashayekhi K, Fusaro M, Leistner DM, Ayoub M, Xhepa E, Joner M, Kastrati A, Cassese S, Rheude T. Randomized ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2: Design and Rationale of the ISAR-CALC 2 Trial. Cardiovasc Revasc Med. 2023 Apr;49:22-27. doi: 10.1016/j.carrev.2022.12.008. Epub 2022 Dec 30.
PubMed 36609101
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05072730
- Acronym / sponsor ID
- ISAR-CALC2 / GE IDE Nr. BA00421
- Conditions
- Calcified Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Collaborators
- Abbott Medical Devices, SIS Medical AG
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
Detailed information is provided elsewhere.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Super high-pressure balloon (OPN NC) | Experimental | Device: Super High Pressure Balloon (OPN NC)Patients will be treated with a Super High Pressure percutaneous transluminal coronary angioplasty (PTCA) Balloon (OPN NC). |
| Intravascular lithotripsy (IVL) | Experimental | Device: Intravascular lithotripsy (IVL)Patients will be treated with intravascular lithotripsy (IVL). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Super High Pressure Balloon (OPN NC)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. | Device | Super high-pressure balloon (OPN NC) |
| Intravascular lithotripsy (IVL)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. | Device | Intravascular lithotripsy (IVL) |
Primary outcome
Final angiographic minimal lumen diameter
Time frame: Intraprocedural.
The primary outcome measure of the trial is the final angiographic minimal lumen diameter as assessed by angiographic core laboratory.
8 secondary outcomes
Angiographic Success
Time frame: Intraprocedural.
Procedural Success
Time frame: During index hospitalization, assessed up to 30 days.
Strategy Success
Time frame: Intraprocedural.
Acute lumen gain
Time frame: Intraprocedural.
Complementary lesion preparation
Time frame: Intraprocedural.
MACE rates
Time frame: 30 days.
Stent expansion as assessed by OCT imaging.
Time frame: Intraprocedural.
Cost-effectiveness analysis
Time frame: Intraprocedural.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Derived from this study: PubMed 36609101Scalamogna M, Abdel-Wahab M, Mashayekhi K, Fusaro M, Leistner DM, Ayoub M, Xhepa E, Joner M, Kastrati A, Cassese S, Rheude T. Randomized ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2: Design and Rationale of the ISAR-CALC 2 Trial. Cardiovasc Revasc Med. 2023 Apr;49:22-27. doi: 10.1016/j.carrev.2022.12.008. Epub 2022 Dec 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvatore Cassese, MD, PhD principal investigator
Deutsches Herzzentrum Munich
Tobias Rheude, MD principal investigator
Deutsches Herzzentrum Munich
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super High Pressure Balloon (OPN NC) and Intravascular lithotripsy (IVL) in people with Calcified Coronary Artery Disease, run by Deutsches Herzzentrum Muenchen at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final angiographic minimal lumen diameter (time frame: Intraprocedural.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05072730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.