An interventional study of Intravascular Lithotripsy and Cutting Balloon in Treatment in Calcified Coronary Disease, sponsored by Baim Institute for Clinical Research. Completed at 22 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Baim Institute for Clinical Research · Not applicable, Interventional, and Treatment
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.
The trial will be composed of two cohorts:
Randomization to either cutting balloon angioplasty or intravascular lithotripsy will occur as follows in the 2 cohorts:
The trial is designed to demonstrate non-inferiority between cutting balloon angioplasty and intravascular lithotripsy in each cohort with regards to the primary endpoint of post-procedural stent area as measured by intravascular imaging at the site of maximal calcification.
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 vessel is a native coronary artery with either:
The target lesion has evidence of significant calcium at the lesion site defined either as,
Exclusion Criteria:
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Patient has suffered a recent cerebrovascular event (stroke/TIA) within last 30 days
Angiographic Exclusion Criteria
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Device: Intravascular Lithotripsy
Device: Cutting Balloon
Intravascular lithotripsy will be performed with or without rotational atherectomy prior to drug-eluting stent implantation in patients with moderate to severely calcified coronary arteries.
Cutting Balloon therapy will be performed with or without rotational atherectomy prior to drug-eluting stent implantation in patients with moderate to severely calcified coronary arteries.
Primary Endpoint
Post-procedural stent area at the point of maximum calcification as measured by intravascular imaging
Time frame: 30 days
Procedural Cost
Time frame: Index procedure
Procedural success
Procedural success defined as stent delivery with a residual stenosis \< 20% in the absence of significant angiographic complication (e.g. severe dissection, perforation, abrupt closure or no-reflow) with final TIMI 3 flow in the target vessel and the absence of intra-procedural death
Time frame: Index procedure
Angiographic success
Angiographic success defined as stent delivery with a residual stenosis \< 20% in the absence of significant angiographic complication (e.g. severe dissection, perforation, abrupt closure or no-reflow)
Time frame: Index procedure
Strategy success
Strategy success defined as stent delivery with a residual stenosis \< 20% in the absence of significant angiographic complication (e.g., severe dissection, perforation, abrupt closure or no-reflow and not having to use an alternative calcium modification device (e.g. atherectomy device or specialty balloon other than routine non-compliant balloon)
Time frame: Index procedure
Peri-procedural Myocardial Infarction
Peri-procedural Myocardial Infarction as defined by Academic Research Consortium-2
Time frame: within 48 hours of index procedure
In-hospital MACCE
In-hospital MACCE defined as composite of all-cause death, unplanned urgent target vessel revascularization, unplanned cardiothoracic surgery, spontaneous myocardial infarction or stroke/TIA at hospital discharge.
Time frame: hospitalization
30 Day MACCE
30 Day MACCE defined as composite of all-cause death, unplanned target vessel revascularization, unplanned cardiothoracic surgery, spontaneous myocardial infarction or stroke/TIA at 30 days
Time frame: 30 days
Plan to share: No
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Baim Institute for Clinical Research