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

NCT06089135 | Completed FDA Device

• 1 other identifier: BBC22
• Study Type: interventional
• Target: 413
• Locations: 1 country
• Sites: 22

Brief Summary

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.

Conditions

Treatment in Calcified Coronary Disease

Keywords

Intravascular Lithoplasty; Cutting Balloon; Calcified Coronary Disease; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  Post-procedural stent area at the point of maximum calcification as measured by intravascular imaging

  30 days

Secondary Outcomes (7)

• Procedural Cost

  Index procedure

• Procedural success

  Index procedure

• Angiographic success

  Index procedure

• Strategy success

  Index procedure

• Peri-procedural Myocardial Infarction

  within 48 hours of index procedure

Study Arms (2)

Intravascular Lithotripsy

ACTIVE COMPARATOR

Device: Intravascular Lithotripsy

Cutting Balloon

ACTIVE COMPARATOR

Device: Cutting Balloon

Interventions

Cutting Balloon DEVICE

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.

Cutting Balloon

Intravascular Lithotripsy DEVICE

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.

Intravascular Lithotripsy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
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• Presence of large thrombus in the target vessel
• Inability to pass coronary guidewire across the lesion

Sponsors & Collaborators

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

Study Sites (22)

UAB Structural Heart and Valve Clinic

Birmingham, Alabama, 35233, United States

Location

Banner Health

Phoenix, Arizona, 85012, United States

Location

Honor Health

Scottsdale, Arizona, 13400, United States

Location

UCSF Cardiology

San Francisco, California, 94117, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

Saint Luke's

Overland Park, Kansas, 66207, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medcial Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

Capital Cardiology

Albany, New York, 12211, United States

Location

Columbia Cardiology

New York, New York, 10032, United States

Location

Columbia University Medical Center/ NewYork Presbyterian Hospital

New York, New York, 10032, United States

Location

Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Wellspan York Hospital

York, Pennsylvania, 17403, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Baylor Scott and White Health

Plano, Texas, 75024, United States

Location

UVA Heart and Vascular Center

Charlottesville, Virginia, 22903, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (6)

• 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.

  PMID: 33441017 BACKGROUND

• 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.

  PMID: 36262074 BACKGROUND

• 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.

  PMID: 22562910 BACKGROUND

• 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.

  PMID: 30354632 BACKGROUND

• 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.

  PMID: 36841945 BACKGROUND

• 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.

  PMID: 37676225 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 18, 2023
• Study Start: December 31, 2023
• Primary Completion: August 30, 2025
• Study Completion: September 30, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (22)