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: * Patients treated with up-front rotational atherectomy * Patients in whom atherectomy is not planned Randomization to either cutting balloon angioplasty or intravascular lithotripsy will occur as follows in the 2 cohorts: * After rotational atherectomy is safely completed In the rotational atherectomy arm * After safe and successful wire crossing in patients in whom atherectomy is not planned. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
413
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.
UAB Structural Heart and Valve Clinic
Birmingham, Alabama, United States
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.
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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
...and 12 more locations
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