RecruitingNot Applicable

Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy

Germany666 participantsStarted 2024-07-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Combined endpoint of major cardiac and cerebrovascular events

Timeframe: 12 months after randomization

Trial details

NCT IDNCT06369142

SponsorDeutsches Herzzentrum Muenchen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Salvatore Cassese, MD, PHD

+49891218 cassese@dhm.mhn.de

View on ClinicalTrials.gov More Coronary Artery Disease trials