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Completed

NCT Number: NCT05072730

ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2

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.

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Key information

Conditions

Calcified Coronary Artery Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herz- und Diabeteszentrum NRW Universitätsklinikum der Ruhr-Universität Bochum, Bad Oeynhausen, Germany

Loading trial locations.

About this study

Detailed information is provided elsewhere.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Angiographic Success

    Time frame: Intraprocedural.

    Defined as target lesion residual angiographic stenosis < 30% in the presence of Thrombolysis in Myocardial Infarction (TIMI) 3 flow.

  2. Procedural Success

    Time frame: During index hospitalization, assessed up to 30 days.

    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.

  3. Strategy Success

    Time frame: Intraprocedural.

    Defined as procedural success using the assigned study device and DES, without requirement for additional devices for lesion preparation; i.e. rotational atherectomy

  4. Acute lumen gain

    Time frame: Intraprocedural.

    Defined as minimal lumen diameter (MLD) after balloon angioplasty with the assigned study devices minus baseline MLD.

  5. Complementary lesion preparation

    Time frame: Intraprocedural.

    Need for complementary lesion preparation with rotational atherectomy

  6. MACE rates

    Time frame: 30 days.

    Occurrence of major adverse cardiac event (MACE) up to 30 days.

  7. Stent expansion as assessed by OCT imaging.

    Time frame: Intraprocedural.

    Stent expansion index, defined as minimum stent area divided by mean reference lumen area assessed with OCT imaging.

  8. Cost-effectiveness analysis

    Time frame: Intraprocedural.

    Cost-effectiveness analysis of OPN versus IVL in severely calcified coronary lesions treated with DES implantation.

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Collaborators

  • Abbott Medical Devices
  • SIS Medical AG

Registry information

Official study 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

Acronym: ISAR-CALC2

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 11, 2021
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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