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Treatment in Calcified Coronary DiseaseShort-CutNCT06089135

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

A study testing Intravascular Lithotripsy and Cutting Balloon in people with Treatment in Calcified Coronary Disease, run by Baim Institute for Clinical Research at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Treatment in Calcified Coronary Disease
What is being tested?
Intravascular Lithotripsy and Cutting Balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
413 participants
Where
22 sitesUnited States
Study dates
31 Dec 2023to 30 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • <!-- -->
  • 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
Show all 22Show fewer
  • 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
  • <!-- -->
  • 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

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • Capital Cardiology

    Albany, New York, 12211

  • UAB Structural Heart and Valve Clinic

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medcial Center

    Boston, Massachusetts, 02215

  • UVA Heart and Vascular Center

    Charlottesville, Virginia, 22903

  • Christ Hospital

    Cincinnati, Ohio, 45219

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75226

  • Henry Ford Health

    Detroit, Michigan, 48202

  • Houston Methodist

    Houston, Texas, 77030

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale School of Medicine

    New Haven, Connecticut, 06510

  • Columbia Cardiology

    New York, New York, 10032

  • Columbia University Medical Center/ NewYork Presbyterian Hospital

    New York, New York, 10032

  • Saint Luke's

    Overland Park, Kansas, 66207

  • Banner Health

    Phoenix, Arizona, 85012

  • UPMC

    Pittsburgh, Pennsylvania, 15213

  • Baylor Scott and White Health

    Plano, Texas, 75024

  • Maine Medical Center

    Portland, Maine, 04102

  • UCSF Cardiology

    San Francisco, California, 94117

  • Honor Health

    Scottsdale, Arizona, 13400

  • University of Washington

    Seattle, Washington, 98195

  • Wellspan York Hospital

    York, Pennsylvania, 17403

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Intravascular Lithotripsy, Cutting Balloon
Keywords
Intravascular Lithoplasty, Cutting Balloon, Calcified Coronary Disease, Percutaneous Coronary Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravascular LithotripsyDevice

    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 BalloonDevice

    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.

Study groups in NCT06089135
Study groupRoleWhat they receive
Intravascular LithotripsyActive comparatorNot described
Receives: Device: Intravascular Lithotripsy
Cutting BalloonActive comparatorNot described
Receives: Device: Cutting Balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Endpoint

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

    Measured: 30 days

Secondary outcomes (7)

  1. Procedural Cost

    Measured: Index procedure

  2. 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

    Measured: Index procedure

  3. 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)

    Measured: Index procedure

  4. 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)

    Measured: Index procedure

  5. Peri-procedural Myocardial Infarction

    Peri-procedural Myocardial Infarction as defined by Academic Research Consortium-2

    Measured: within 48 hours of index procedure

  6. 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.

    Measured: hospitalization

  7. 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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2023
  2. Study start31 Dec 2023
  3. Primary completion30 Aug 2025
  4. Study completion30 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
413 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06089135
Sponsor's protocol ID
BBC22
Acronym
Short-Cut
Status last verified
Jan 2026
First submitted
6 Oct 2023
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 33441017

  • 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.

    PubMed 36262074

  • 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.

    PubMed 22562910

  • 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.

    PubMed 30354632

  • 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.

    PubMed 36841945

  • 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.

    PubMed 37676225

Questions about this trial

What is this clinical trial studying?

A study testing Intravascular Lithotripsy and Cutting Balloon in people with Treatment in Calcified Coronary Disease, run by Baim Institute for Clinical Research at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoint (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06089135, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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