Intravascular Lithotripsy for Heart Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called Shockwave Intravascular Lithotripsy to determine its safety and effectiveness for individuals with certain types of heart disease. The focus is on treating blocked heart arteries, known as coronary artery lesions, that have hardened due to calcium buildup. Individuals who have experienced stable chest pain or have recovered from a recent heart event might be suitable candidates. The researchers aim to discover if this treatment can help open arteries before placing a stent, a tiny tube used to keep arteries open. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance heart disease treatments.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, you must be able to tolerate antiplatelet or anticoagulation therapy as per guidelines, and if you have taken warfarin recently, your INR (a blood test) must be checked.
What prior data suggests that the Shockwave Intravascular Lithotripsy is safe for treating coronary artery lesions?
Research has shown that the Shockwave Intravascular Lithotripsy (IVL) system is generally safe for treating hardened areas in the heart's arteries. Early studies have found that patients usually handle the procedure well. Initial results from using the Shockwave Javelin Coronary IVL Catheter indicated it is both safe and effective for treating tough artery blockages.
Additionally, one study found that patients experienced lasting positive results and safety over time. These findings are encouraging, but it's important to remember that all medical treatments can have risks. Participants in this trial will contribute to a better understanding of the treatment's safety.12345Why are researchers excited about this trial?
Shockwave Intravascular Lithotripsy is unique because it uses sound waves to break up calcified plaques in the coronary arteries, which is different from the standard methods like balloon angioplasty or stenting. Most treatments for coronary artery disease rely on physically expanding the artery, but this treatment targets the underlying calcification directly, potentially reducing the risk of further complications. Researchers are excited about this technique because it offers a less invasive option that could lead to better outcomes for patients with severely calcified arteries.
What evidence suggests that the Shockwave Intravascular Lithotripsy is effective for heart disease?
Research has shown that the Shockwave Intravascular Lithotripsy (IVL) system, which participants in this trial will receive, effectively treats narrowed heart arteries hardened by calcium buildup. Early studies indicate that the IVL system safely breaks down these calcium blockages, facilitating stent insertion. Initial findings suggest the procedure is safe and offers good long-term results, with stents maintaining their effectiveness over time. Patients treated with this method demonstrated significant improvement in blood flow through the treated arteries. This new approach targets tough calcium deposits that traditional methods find difficult to treat.13456
Who Is on the Research Team?
Robert W Yeh, M.D., M.Sc, M.B.A
Principal Investigator
Beth Israel Deaconess Medical Center
James C Spratt, MD, MB, ChB, FRCP, FESC, FACC
Principal Investigator
St. George's University NHS Trust
Robert F Riley, MD, MS, FACC, FAHA, FSCAI
Principal Investigator
Overlake Medical Center & Clinics
Are You a Good Fit for This Trial?
The FORWARD CAD IDE Study is for adults over 18 with heart disease, specifically those with calcified, stenotic de novo coronary artery lesions. Participants must have a life expectancy of more than a year, be able to follow the study's procedures, and have left ventricular ejection fraction (LVEF) greater than 30%. They should not have had previous successful interventions on the lesion and must consent to participate.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive treatment with the Shockwave Javelin Coronary IVL Catheter for calcified coronary artery lesions
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on freedom from major adverse cardiac events (MACE) within 30 days
What Are the Treatments Tested in This Trial?
Interventions
- Shockwave Intravascular Lithotripsy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shockwave Medical, Inc.
Lead Sponsor