Shockwave Therapy for Coronary Artery Disease

N/A

Recruiting

Research Sponsored by Shockwave Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is ≥18 years of age

Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 days of index procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a device to clear plaque from blocked coronary arteries to improve blood flow before stenting.

Who is the study for?

This trial is for adults over 18 with coronary artery disease, including those with stable or unstable angina and silent ischemia suitable for PCI. Participants must have normal levels of certain heart enzymes before the procedure and a left ventricular ejection fraction greater than 25%. They must consent to participate.

What is being tested?

The study tests the Shockwave C2+ 2Hz Coronary IVL Catheter's safety and effectiveness in treating calcified, narrowed arteries in the heart before stenting. It uses shockwaves to modify arterial calcium.

What are the potential side effects?

Potential side effects may include discomfort at the catheter insertion site, bleeding, blood vessel complications, irregular heartbeats, or reactions related to pressure changes from shockwaves.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have heart disease that can be treated with a procedure to open my arteries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 days of index procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 days of index procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days of index procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure

Number of Participants With Procedural Success (Residual Stenosis <30%)

Secondary study objectives

All-Cause Death Rate at 12 Months

All-Cause Death Rate at 30 Days

All-Cause Death Rate at 6 Months

+46 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single-ArmExperimental Treatment1 Intervention

Subjects with de novo, calcified coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI).

0 / 2Eligibility criteria met