Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy

Coronary Artery Disease Clinical Trial

— ISAR-WAVE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06369142
• Other study ID #: GE IDE No. L00123
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: July 31, 2027

Study information

• Verified date: April 2024
• Source: Deutsches Herzzentrum Muenchen
• Contact: Salvatore Cassese, MD, PHD
• Phone: +49891218
• Email: cassese[@]dhm.mhn.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 666
• Est. completion date: July 31, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum München	Munich	Bavaria

Sponsors (5)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen	EvidentIQ Germany GmbH, Gemeinsamer Bundesaussschuss, Institute of AI and Informatics in Medicine Technical University of Munich, Monitoring Services GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined endpoint of major cardiac and cerebrovascular events	all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, clinically indicated revascularisation of the target vessel	12 months after randomization
Secondary	Mortality		12 months after randomization
Secondary	Cardiac mortality		12 months after randomization
Secondary	Non-fatal myocardial infarction		12 months after randomization
Secondary	Non-fatal stroke		12 months after randomization
Secondary	Clinically indicated target vessel revascularization		12 months after randomization
Secondary	Definite stent thrombosis		12 months after randomization
Secondary	Clinically indicated non-target vessel revascularization		12 months after randomization
Secondary	Hospitalization due to acute coronary syndrome		12 months after randomization
Secondary	Symptoms of coronary heart disease (CHD): physical health status		12 months after randomization
Secondary	Symptoms of CHD: mental health status		12 months after randomization
Secondary	Bleeding during index hospitalization or =30 days (BARC 3-5)		30 days after randomization
Secondary	Procedural failure (failed application of study-related additional procedure, final TIMI flow <3, >30% residual stenosis, vessel perforation, stent loss, stent delivery failure)		12 months after randomization
Secondary	Medical costs (index hospitalization and costs for re-hospitalization due to acute coronary syndrome)		12 months after randomization