Shockwave Therapy for Coronary Artery Disease
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo percutaneous coronary intervention (PCI) using the Shockwave Coronary Intravascular Lithotripsy (IVL) System
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Shockwave C2+ 2Hz Coronary IVL Catheter
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shockwave Medical, Inc.
Lead Sponsor