Shockwave Therapy for Coronary Artery Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for coronary artery disease, a condition where calcium deposits clog heart arteries. The study tests the Shockwave C2+ 2Hz Coronary IVL Catheter, a device that uses sound waves to break up tough calcium buildups before placing a stent to keep arteries open. Suitable participants have coronary artery disease with stable or unstable chest pain and have not undergone previous interventional procedures on the target artery. Those experiencing chest pain related to heart disease and lacking certain prior treatments may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to innovative research in coronary artery disease treatment.
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 prior data suggests that this device is safe for treating coronary artery disease?
Research shows that the Shockwave C2+ 2Hz Coronary IVL Catheter safely breaks up calcium in heart arteries, improving blood flow and treating coronary artery disease. Previous studies found that patients generally tolerate the procedure well.
Although specific side effects from these studies are not detailed in available sources, using sound waves to treat hardened arteries is considered innovative and less invasive than other methods, potentially resulting in fewer side effects. Testing the device in a clinical trial suggests confidence in its safety, but more research is needed to fully understand any potential risks.12345Why are researchers excited about this trial?
Unlike traditional treatments for coronary artery disease, such as stenting or bypass surgery, Shockwave Therapy uses a novel approach. This treatment involves a Shockwave C2+ 2Hz Coronary IVL Catheter, which delivers precise acoustic pressure waves to target calcified coronary lesions. This technique can effectively soften the hardened deposits, making it easier for physicians to perform interventions like angioplasty. Researchers are excited because this method could improve the success rates of procedures and potentially reduce the need for more invasive surgeries.
What evidence suggests that this device is effective for coronary artery disease?
Research has shown that the Shockwave C2+ 2Hz Coronary IVL Catheter effectively treats hardened arteries in the heart. This device uses sound waves to break up tough calcium deposits, facilitating stent placement. Studies have found that this method helps clear blocked arteries and improves blood flow. The treatment targets difficult cases where arteries are heavily hardened and resistant to traditional methods. Early results suggest that shockwave therapy is both safe and effective in altering arterial calcium, which is crucial for treating narrowed arteries.12346
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- Shockwave C2+ 2Hz Coronary IVL Catheter
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shockwave Medical, Inc.
Lead Sponsor