Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy (ISAR-WAVE)

German Heart Center Munich

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Device: Standard non-IVL methods; Device: Intravascular lithotripsy (IVL)

Study type: Interventional

Funder types: Other

Identifiers

NCT06369142

GE IDE No. L00123

Details and patient eligibility

About

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.

Enrollment: 666 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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666 participants in 2 patient groups

Lesion preparation using coronary intravascular lithotripsy

Experimental group

Treatment:

Device: Intravascular lithotripsy (IVL)

Lesion preparation using other methods than intravascular lithotripsy

Active Comparator group

Description:

e.g. cutting or super high pressure balloons and/or ablative procedures

Treatment:

Device: Standard non-IVL methods