Lithotripsy vs Cutting Balloon for Coronary Artery Disease
(Short-Cut Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to compare two treatments—cutting balloon angioplasty and intravascular lithotripsy, which uses sound waves to break up calcium deposits—to determine which is more effective before placing a drug-eluting stent in individuals with moderate to severely calcified coronary arteries. Calcium buildup narrows and hardens these arteries, affecting blood flow to the heart. Suitable candidates for this trial have been diagnosed with coronary artery disease and require a procedure to open a blocked heart artery, especially if they experience symptoms like chest pain or have had a positive stress test for heart issues.
As an unphased trial, this study provides an opportunity to contribute to valuable research that could enhance treatment options for coronary artery disease.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both cutting balloon angioplasty and intravascular lithotripsy are generally well-tolerated treatments for hardened coronary arteries.
For the cutting balloon, studies have found a high success rate in performing the procedure. Patients report good results without major side effects, indicating that the treatment is relatively safe with no significant complications.
Regarding intravascular lithotripsy, studies report a success rate of 98.8% for the procedure. Serious complications like vessel perforation and major tears are rare, occurring in less than 1% of cases. Overall, negative events are uncommon, making it a generally safe option.
Both treatments have demonstrated promising safety records in past studies, with low rates of serious complications.12345Why are researchers excited about this trial's treatments?
Most treatments for coronary artery disease, like traditional balloon angioplasty and stenting, focus on physically widening the artery. But intravascular lithotripsy is different because it uses sound waves to break up calcium deposits in the arteries, making it easier to open them up. This technique can be especially helpful for patients with heavily calcified arteries, where standard methods might struggle. Meanwhile, the cutting balloon combines dilation with tiny blades that score the artery plaque, potentially leading to more precise plaque modification. Researchers are excited about these methods as they offer new ways to tackle complex arterial blockages, which are difficult to treat with existing options.
What evidence suggests that this trial's treatments could be effective for coronary artery disease?
This trial will compare the effectiveness of cutting balloon angioplasty and intravascular lithotripsy (IVL) for treating coronary artery disease. Research has shown that cutting balloon angioplasty effectively treats coronary artery disease, reducing the risk of needing repeat procedures compared to regular balloons, though it may not decrease the chance of the artery narrowing again after treatment. Intravascular lithotripsy (IVL), another treatment option in this trial, uses sound waves to break up hard calcium in the arteries. Studies have demonstrated that IVL is safe and aids in successfully placing stents in arteries with significant calcium buildup. It also boasts a high success rate with few complications, making it a reliable choice for patients with complex artery conditions.12678
Are You a Good Fit for This Trial?
This trial is for adults over 21 with moderate to severely calcified coronary arteries, who have a stenosis of more than 50% but less than 70%, and show signs of ischemia. They must need PCI treatment for conditions like stable coronary artery disease, unstable angina, or NSTEMI with decreasing biomarkers.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either cutting balloon angioplasty or intravascular lithotripsy, with or without rotational atherectomy, followed by drug-eluting stent implantation
Follow-up
Participants are monitored for safety and effectiveness, including assessment of post-procedural stent area and MACCE at 30 days
What Are the Treatments Tested in This Trial?
Interventions
- Cutting Balloon
- Intravascular Lithotripsy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baim Institute for Clinical Research
Lead Sponsor
Kathleen Kearney, MD
Collaborator
Robert W. Yeh, MD
Collaborator
Akiko Maehara, MD
Collaborator
Ajay Kirtane, MD
Collaborator
C. Michael Gibson, MS, MD
Collaborator
Suzanne Baron, MD
Collaborator