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Recruiting NCT06369142

Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy

No phase Interventional Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intravascular lithotripsy (IVL), Standard non-IVL methods.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device Intravascular lithotripsy (IVL)
    Intravascular lithotripsy (IVL) and ballons with a nominal rated burst pressure of ≤ 18 atm
  • Device Standard non-IVL methods
    Standard non-IVL methods treating severely calcified lesions such as special high, super high and cutting balloons and ablative procedures

Primary outcome measures

  • Combined endpoint of major cardiac and cerebrovascular events [Time frame: 12 months after randomization]
Secondary outcome measures (12)
  • Mortality [Time frame: 12 months after randomization]
  • Cardiac mortality [Time frame: 12 months after randomization]
  • Non-fatal myocardial infarction [Time frame: 12 months after randomization]
  • Non-fatal stroke [Time frame: 12 months after randomization]
  • Clinically indicated target vessel revascularization [Time frame: 12 months after randomization]
  • Definite stent thrombosis [Time frame: 12 months after randomization]
  • Clinically indicated non-target vessel revascularization [Time frame: 12 months after randomization]
  • Hospitalization due to acute coronary syndrome [Time frame: 12 months after randomization]
  • Symptoms of coronary heart disease (CHD): physical health status [Time frame: 12 months after randomization]
  • Symptoms of CHD: mental health status [Time frame: 12 months after randomization]
  • Bleeding during index hospitalization or ≤30 days (BARC 3-5) [Time frame: 30 days after randomization]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Germany · 22 centers
  • Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie — Heidelberg
  • Universitätsklinikum Mannheim GmbH, I. Medizinische Klinik, Kardiologie, Angiologie, Hämos — Mannheim
  • Hegau-Bodensee-Klinikum Singen GmbH, I. Medizinsche Klinik (Kardiologie und internistische — Singen
  • Cardiologikum Herzklinik Ulm MVZ — Ulm
  • Universitätsklinikum Ulm — Ulm
  • Universitätsklinikum Augsburg A.ö.R. — Augsburg
  • Helios Amper-Klinikum Dachau, Kardiologie und Pneumologie — Dachau
  • Klinikum Landkreis Erding — Erding
  • … and 14 more centers

Publications

  • Cassese S, Simonetti F, Covarrubias HAA, Janisch M, Joner M, Kufner S, Lenz T, Pellegrini C, Rheude T, Sager H, Schunkert H, Starnecker F, Voll F, Xhepa E, Kastrati A, Kessler T. Intracoronary stenting and additional results achieved by shockWAVE coronary lithotripsy: design and rationale of ISAR-WAVE trial. Am Heart J. 2025 Apr;282:1-12. doi: 10.1016/j.ahj.2024.12.008. Epub 2024 Dec 20. PMID 39710352

Identifiers

NCT: NCT06369142 · GE IDE No. L00123

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗