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

Completed · Not applicable

Conditions studied: Treatment in Calcified Coronary Disease

In brief

The Short-Cut trial is a prospective, investigator-initiated, multicenter, randomized controlled trial that is designed to compare the efficacy of cutting balloon angioplasty vs. intravascular lithotripsy prior to drug-eluting stent implantation in patients with moderate to severely calcified coronary arteries.

Key facts

Study ID

NCT06089135

Run by

Baim Institute for Clinical Research

People needed

413

Starts

2023-12-31

Expected to finish

2025-09-30

Last updated by the study team

2026-01-23

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• The target lesion is a de novo native coronary lesion
• The target vessel is a native coronary artery with either:
• A stenosis > 70%; or,
• 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
• The reference diameter of the target vessel is > 2.5mm and < 4.0 mm at the lesion site
• The target lesion has evidence of significant calcium at the lesion site defined either as,
• The presence of radiopacities involving both sides of the arterial wall > 5mm and involving the target lesion on angiography
• the presence of > 270o arc of superficial calcium on intravascular imaging with a length > 5mm or the presence of 360o arc of superficial calcium

You may not qualify if…

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• Patient is pregnant
• Patient is actively participating in another clinical trial
• Known LVEF < 25%
• Ongoing Non-STEMI with rising biomarkers
• Cardiogenic shock or requirement for mechanical/pharmacologic hemodynamic support
• Planned use in the randomized lesion of a bare metal stent or non-stent treatment only
• Patient has a known allergy to contrast which cannot be adequately pre-treated
• Patient has a history of bleeding or coagulopathy and is unable to receive blood transfusion if needed
• Patient presents with STEMI
• Patient is unable to tolerate dual anti-platelet therapy
• Patient has suffered a recent cerebrovascular event (stroke/TIA) within last 30 days
• Angiographic Exclusion Criteria
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• Presence of large thrombus in the target vessel
• Inability to pass coronary guidewire across the lesion
• 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
• The target lesion is within a coronary artery bypass graft
• The target lesion involves a bifurcation lesion in which either a 2-stent strategy is planned or both branches are planned for calcium modification
• Coronary artery disease that requires surgical revascularization
• Angiographic or imaging evidence of dissection in the target vessel prior to randomization
• Investigator feels there is not equipoise regarding the treatment strategy

Where it is running

• UAB Structural Heart and Valve Clinic — Birmingham, Alabama, United States
• Banner Health — Phoenix, Arizona, United States
• Honor Health — Scottsdale, Arizona, United States
• UCSF Cardiology — San Francisco, California, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Saint Luke's — Overland Park, Kansas, United States
• Maine Medical Center — Portland, Maine, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medcial Center — Boston, Massachusetts, United States
• Henry Ford Health — Detroit, Michigan, United States
• Capital Cardiology — Albany, New York, United States
• Columbia Cardiology — New York, New York, United States
• Columbia University Medical Center/ NewYork Presbyterian Hospital — New York, New York, United States
• Christ Hospital — Cincinnati, Ohio, United States
• UPMC — Pittsburgh, Pennsylvania, United States
• Wellspan York Hospital — York, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor Heart and Vascular Hospital — Dallas, Texas, United States
• Houston Methodist — Houston, Texas, United States
• Baylor Scott and White Health — Plano, Texas, United States
• UVA Heart and Vascular Center — Charlottesville, Virginia, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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