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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Intravascular lithotripsy (IVL); Device: Standard non-IVL methods

• Study Type: Interventional
• Enrollment (Estimated): 666
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Salvatore Cassese, MD, PHD; Phone Number: 2764 +49891218; Email: cassese@dhm.mhn.de
• Study Contact Backup: Name: Thorsten Kessler, MD; Phone Number: 2786 +49891218; Email: thorsten.kessler@tum.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80636
      • Deutsches Herzzentrum München
      • Contact: Salvatore Cassese, MD, PHD; Phone Number: 2764 0049891218; Email: cassese@dhm.mhn.de
      • Principal Investigator: Salvatore Cassese, MD, PDH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lesion preparation using coronary intravascular lithotripsy	Device: Intravascular lithotripsy (IVL); Intravascular lithotripsy (IVL) and ballons with a nominal rated burst pressure of ≤ 18 atm
Active Comparator: Lesion preparation using other methods than intravascular lithotripsy; e.g. cutting or super high pressure balloons and/or ablative procedures	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Mortality	12 months after randomization
Cardiac mortality	12 months after randomization
Non-fatal myocardial infarction	12 months after randomization
Non-fatal stroke	12 months after randomization
Clinically indicated target vessel revascularization	12 months after randomization
Definite stent thrombosis	12 months after randomization
Clinically indicated non-target vessel revascularization	12 months after randomization
Hospitalization due to acute coronary syndrome	12 months after randomization
Symptoms of coronary heart disease (CHD): physical health status	12 months after randomization
Symptoms of CHD: mental health status	12 months after randomization
Bleeding during index hospitalization or ≤30 days (BARC 3-5)	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)	12 months after randomization
Medical costs (index hospitalization and costs for re-hospitalization due to acute coronary syndrome)	12 months after randomization

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen
• Collaborators: EvidentIQ Germany GmbH; Institute of AI and Informatics in Medicine Technical University of Munich; Gemeinsamer Bundesaussschuss; Monitoring Services GmbH
• Investigators: Study Chair: Adnan Kastrati, MD, Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Stent; Coronary Artery Disease; Percutaneous Coronary Intervention; Intravascular Lithotripsy; Calcified lesion
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: GE IDE No. L00123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No