Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial

Launched by BAIM INSTITUTE FOR CLINICAL RESEARCH · Oct 16, 2023

Keywords

ClinConnect Summary

The Short-Cut trial is a study designed to compare two different treatments for patients with calcified coronary arteries, which can cause heart problems. Specifically, the trial is looking at the effectiveness of a method called cutting balloon angioplasty versus another method called intravascular lithotripsy before placing a stent (a small tube that helps keep arteries open) in patients with moderate to severe calcium buildup in their heart arteries. This trial is currently recruiting participants who are at least 21 years old and have certain heart conditions, such as stable coronary artery disease or unstable angina.

If you or someone you know is interested in participating, it's important to know that participants will need to provide informed consent and meet specific health criteria. For example, eligible patients should have significant narrowing of a coronary artery and evidence of calcium buildup that could complicate treatment. Participants will receive one of the two treatments and will be monitored closely during the process. Overall, this trial aims to find out which treatment is more effective in helping patients with calcified coronary disease.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is \> 21 years old 2. Subject with an indication for PCI for the treatment of a) stable coronary artery disease; b) unstable angina; or c) NSTEMI with evidence of down-trending biomarkers 3. Subject is willing and able to provide informed written consent Angiographic Inclusion Criteria
• • 1. The target lesion is a de novo native coronary lesion
• 2. The target vessel is a native coronary artery with either:
• • 1. A stenosis \> 70%; or,
• • 2. A stenosis \> 50% and \<70% with evidence of ischemia via either positive stress test, FFR value \< 0.80 or RFR/iFR/DFR value \< 0.89
• • 3. The reference diameter of the target vessel is \> 2.5mm and \< 4.0 mm at the lesion site
• • 4. The target lesion has evidence of significant calcium at the lesion site defined either as,
• • 1. The presence of radiopacities involving both sides of the arterial wall \> 5mm and involving the target lesion on angiography
• • 2. the presence of \> 270o arc of superficial calcium on intravascular imaging with a length \> 5mm or the presence of 360o arc of superficial calcium
• Exclusion Criteria:
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• • 1. Patient is pregnant
• • 2. Patient is actively participating in another clinical trial
• • 3. Known LVEF \< 25%
• • 4. Ongoing Non-STEMI with rising biomarkers
• • 5. Cardiogenic shock or requirement for mechanical/pharmacologic hemodynamic support
• • 6. Planned use in the randomized lesion of a bare metal stent or non-stent treatment only
• • 7. Patient has a known allergy to contrast which cannot be adequately pre-treated
• • 8. Patient has a history of bleeding or coagulopathy and is unable to receive blood transfusion if needed
• • 9. Patient presents with STEMI
• • 10. Patient is unable to tolerate dual anti-platelet therapy
• • 11. Patient has suffered a recent cerebrovascular event (stroke/TIA) within last 30 days
• • Angiographic Exclusion Criteria
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• • 1. Presence of large thrombus in the target vessel
• • 2. Inability to pass coronary guidewire across the lesion
• • 3. The target vessel has excessive tortuosity (Defined as presence of 2+ bends \> 90o or 3+ bends \> 75o) or other anatomic considerations that precludes intravascular imaging
• • 4. The target lesion is within a coronary artery bypass graft
• • 5. The target lesion involves a bifurcation lesion in which either a 2-stent strategy is planned or both branches are planned for calcium modification
• • 6. Coronary artery disease that requires surgical revascularization
• • 7. Angiographic or imaging evidence of dissection in the target vessel prior to randomization
• • 8. Investigator feels there is not equipoise regarding the treatment strategy