145 Participants Needed

Shockwave Therapy for Coronary Artery Disease

Recruiting at 17 trial locations
RR
Overseen ByRandee Randoll
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Shockwave Medical, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be able to tolerate antiplatelet or anticoagulation therapy as per guidelines.

What data supports the effectiveness of the Shockwave C2+ 2Hz Coronary IVL Catheter treatment for coronary artery disease?

Research shows that the Shockwave intravascular lithotripsy (IVL) treatment is effective in breaking down hard calcium deposits in coronary arteries, which helps in better stent placement and expansion. This technique has been successfully used in real-world settings to treat severe calcified coronary lesions, improving outcomes for patients with coronary artery disease.12345

Is Shockwave Therapy for Coronary Artery Disease safe for humans?

Research shows that Shockwave Therapy, also known as intravascular lithotripsy (IVL), has been used safely in treating calcified coronary arteries. Studies report low rates of major adverse events, such as heart attacks or the need for additional procedures, indicating it is generally safe for human use.16789

What makes Shockwave Therapy for Coronary Artery Disease unique?

Shockwave Therapy for Coronary Artery Disease is unique because it uses a special catheter to deliver ultrasonic energy that breaks up hard calcium deposits in the arteries, making it easier to place and expand stents. This approach is different from traditional methods as it specifically targets calcified plaques, which are often difficult to treat with standard techniques.123510

What is the purpose of this trial?

This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo, calcified, stenotic, coronary lesions prior to stenting.

Eligibility Criteria

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.

Inclusion Criteria

You or a legally authorized representative must sign a written Informed Consent form prior to engaging in any study-mandated activities.
Before the procedure, CK-MB and troponin levels must both be within normal limits as determined by laboratory standards within 12 hours.
My biomarker results from a recent procedure can be pending for this study.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo percutaneous coronary intervention (PCI) using the Shockwave Coronary Intravascular Lithotripsy (IVL) System

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Visits at discharge, 30 days, 6 months, and 12 months

Treatment Details

Interventions

  • Shockwave C2+ 2Hz Coronary IVL Catheter
Trial Overview 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.
Participant Groups
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).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shockwave Medical, Inc.

Lead Sponsor

Trials
38
Recruited
10,200+

References

Intracoronary Lithotripsy in Calcified Coronary Lesions: A Multicenter Observational Study. [2022]
Sodium Chloride Physiological Saline Solution Versus Water Preparations Injectable in the Use of Shockwave Intravascular Lithotripsy: A Single-Center Experience. [2023]
Intravascular lithotripsy-assisted Impella insertion: A case report. [2020]
Shockwave Intravascular Lithotripsy for Calcified Coronary Lesions: First Real-World Experience. [2019]
Overcoming very late severe calcific stenosis due to two layers of under-expanded stents with intravascular lithotripsy treatment: A case report. [2021]
Intravascular Lithotripsy for Vessel Preparation in Calcified Coronary Arteries Prior to Stent Placement - Japanese Disrupt CAD IV Study 2-Year Results. [2023]
Adverse events with intravascular lithotripsy after coronary use: A report from the FDA MAUDE database. [2023]
Evaluation of safety and efficacy of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: Design and rationale for the Disrupt CAD III trial. [2020]
Calcified Coronary Lesions Treated With Intravascular Lithotripsy: One-Year Outcomes. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Shockwave Intravascular Lithotripsy of Calcified Coronary Lesions in ST-Elevation Myocardial Infarction: First-in-Man Experience. [2019]
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