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Device

Female subjects referred for percutaneous coronary intervention for Coronary Artery Disease (EMPOWER CAD Trial)

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure
Awards & highlights

Summary

Post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease.

Eligible Conditions
  • Coronary Artery Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Effectiveness Endpoint
Primary Safety Endpoint

Trial Design

1Treatment groups
Experimental Treatment
Group I: Female subjects referred for percutaneous coronary interventionExperimental Treatment1 Intervention
Female subjects referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care.

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Who is running the clinical trial?

Shockwave Medical, Inc.Lead Sponsor
30 Previous Clinical Trials
8,959 Total Patients Enrolled
10 Trials studying Coronary Artery Disease
3,390 Patients Enrolled for Coronary Artery Disease
~109 spots leftby Apr 2025
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