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NCT Number: NCT06369142

Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy

The clinical trial is intended to evaluate the efficacy, safety and economic benefit of coronary lithotripsy compared to other additional procedures (cutting or super high pressure balloon angioplasty, ablative procedures) in lesion preparation and interventional treatment of severely calcified coronary stenoses.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie, Heidelberg, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age ≥18 years and able to give informed consent
  • written informed consent to participate in the clinical trial
  • typical angina pectoris or non-invasive evidence of relevant ischemia under optimal drug therapy
  • angiographic evidence of coronary artery disease
  • de novo lesion in a native coronary artery
  • target vessel diameter 2.5-4 mm
  • severe calcification of the target lesion (angiographic grade 3)

Exclusion criteria

  • myocardial infarction <1 week
  • thrombus in the target vessel
  • life expectancy due to other disease <1 year
  • simultaneous participation in a clinical trial with medical devices or medicinal products that has not yet been completed
  • pregnancy (current, suspected, planned) or positive pregnancy test

Treatment and study plan

intravascular lithotripsy (IVL)

Device

Intravascular lithotripsy (IVL) and ballons with a nominal rated burst pressure of ≤ 18 atm

Standard non-IVL methods

Device

Standard non-IVL methods treating severely calcified lesions such as special high, super high and cutting balloons and ablative procedures

Primary outcomes

  1. Combined endpoint of major cardiac and cerebrovascular events

    Time frame: 12 months after randomization

    all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, clinically indicated revascularisation of the target vessel

Secondary outcomes

  1. Mortality

    Time frame: 12 months after randomization

  2. Cardiac mortality

    Time frame: 12 months after randomization

  3. Non-fatal myocardial infarction

    Time frame: 12 months after randomization

  4. Non-fatal stroke

    Time frame: 12 months after randomization

  5. Clinically indicated target vessel revascularization

    Time frame: 12 months after randomization

  6. Definite stent thrombosis

    Time frame: 12 months after randomization

  7. Clinically indicated non-target vessel revascularization

    Time frame: 12 months after randomization

  8. Hospitalization due to acute coronary syndrome

    Time frame: 12 months after randomization

  9. Symptoms of coronary heart disease (CHD): physical health status

    Time frame: 12 months after randomization

  10. Symptoms of CHD: mental health status

    Time frame: 12 months after randomization

  11. Bleeding during index hospitalization or ≤30 days (BARC 3-5)

    Time frame: 30 days after randomization

  12. Procedural failure (failed application of study-related additional procedure, final TIMI flow <3, >30% residual stenosis, vessel perforation, stent loss, stent delivery failure)

    Time frame: 12 months after randomization

  13. Medical costs (index hospitalization and costs for re-hospitalization due to acute coronary syndrome)

    Time frame: 12 months after randomization

Study contacts

Contact information is provided by the study sponsor or research team.

Salvatore Cassese, MD, PHD

CONTACT

[email protected]

+49891218 ext. 2764

Thorsten Kessler, MD

CONTACT

[email protected]

+49891218 ext. 2786

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Collaborators

  • EvidentIQ Germany GmbH
  • Gemeinsamer Bundesaussschuss
  • Monitoring Services GmbH
  • Technical University of Munich

Registry information

Official study title

Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy: A Randomized, Multicenter Study About the Additional Benefit of Coronary Lithotripsy

Acronym: ISAR-WAVE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2024
Registry last updated
Jan 6, 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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