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

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

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.

Study Overview

• Status: Completed
• Conditions: Treatment in Calcified Coronary Disease
• Intervention / Treatment: Device: Intravascular Lithotripsy; Device: Cutting Balloon

Detailed Description

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
• Enrollment (Actual): 413
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB Structural Heart and Valve Clinic
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Banner Health
    • Scottsdale, Arizona, United States, 13400
      • Honor Health
  • California
    • San Francisco, California, United States, 94117
      • UCSF Cardiology
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine
  • Kansas
    • Overland Park, Kansas, United States, 66207
      • Saint Luke's
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medcial Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health
  • New York
    • Albany, New York, United States, 12211
      • Capital Cardiology
    • New York, New York, United States, 10032
      • Columbia University Medical Center/ NewYork Presbyterian Hospital
    • New York, New York, United States, 10032
      • Columbia Cardiology
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Christ Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC
    • York, Pennsylvania, United States, 17403
      • Wellspan York Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75226
      • Baylor Heart and Vascular Hospital
    • Houston, Texas, United States, 77030
      • Houston Methodist
    • Plano, Texas, United States, 75024
      • Baylor Scott and White Health
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • UVA Heart and Vascular Center
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

  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

  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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravascular Lithotripsy	Device: Intravascular Lithotripsy; 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.
Active Comparator: Cutting Balloon	Device: Cutting Balloon; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint	Post-procedural stent area at the point of maximum calcification as measured by intravascular imaging	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Cost		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	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)	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)	Index procedure
Peri-procedural Myocardial Infarction	Peri-procedural Myocardial Infarction as defined by Academic Research Consortium-2	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.	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	30 days

Collaborators and Investigators

• Sponsor: Baim Institute for Clinical Research
• Collaborators: C. Michael Gibson, MS, MD; Akiko Maehara, MD; Robert W. Yeh, MD; Ajay Kirtane, MD; Kathleen Kearney, MD; Suzanne Baron, MD

Publications and helpful links

General Publications

• Shah M, Najam O, Bhindi R, De Silva K. Calcium Modification Techniques in Complex Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2021 May;14(5):e009870. doi: 10.1161/CIRCINTERVENTIONS.120.009870. Epub 2021 Jan 14.
• Allali A, Toelg R, Abdel-Wahab M, Hemetsberger R, Kastrati A, Mankerious N, Traboulsi H, Elbasha K, Rheude T, Landt M, Geist V, Richardt G. Combined rotational atherectomy and cutting balloon angioplasty prior to drug-eluting stent implantation in severely calcified coronary lesions: The PREPARE-CALC-COMBO study. Catheter Cardiovasc Interv. 2022 Nov;100(6):979-989. doi: 10.1002/ccd.30423. Epub 2022 Oct 19.
• Furuichi S, Tobaru T, Asano R, Watanabe Y, Takamisawa I, Seki A, Sumiyoshi T, Tomoike H. Rotational atherectomy followed by cutting-balloon plaque modification for drug-eluting stent implantation in calcified coronary lesions. J Invasive Cardiol. 2012 May;24(5):191-5.
• Mangieri A, Nerla R, Castriota F, Reimers B, Regazzoli D, Leone PP, Gasparini GL, Khokhar AA, Laricchia A, Giannini F, Casale F, Bezzeccheri A, Briguori C, Colombo A. Cutting balloon to optimize predilation for stent implantation: The COPS randomized trial. Catheter Cardiovasc Interv. 2023 Mar;101(4):798-805. doi: 10.1002/ccd.30603. Epub 2023 Feb 25.
• Kereiakes DJ, Hill JM, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Arteries: 2-Year Results-Disrupt CAD III Study. JACC Cardiovasc Interv. 2023 Oct 9;16(19):2472-2474. doi: 10.1016/j.jcin.2023.07.010. Epub 2023 Sep 6. No abstract available.
• Abdel-Wahab M, Toelg R, Byrne RA, Geist V, El-Mawardy M, Allali A, Rheude T, Robinson DR, Abdelghani M, Sulimov DS, Kastrati A, Richardt G. High-Speed Rotational Atherectomy Versus Modified Balloons Prior to Drug-Eluting Stent Implantation in Severely Calcified Coronary Lesions. Circ Cardiovasc Interv. 2018 Oct;11(10):e007415. doi: 10.1161/CIRCINTERVENTIONS.118.007415.

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2023
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Cutting Balloon; Intravascular Lithoplasty; Calcified Coronary Disease
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Ischemia; Coronary Artery Disease; Coronary Disease
• Other Study ID Numbers: BBC22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No