RECRUITING

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

Conditions

Treatment in Calcified Coronary Disease Intravascular Lithoplasty Cutting Balloon Calcified Coronary Disease Percutaneous Coronary Intervention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-12-31

Study Completion:2025-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06089135

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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 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

Inclusion Criteria

Exclusion 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

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
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

Contacts and Locations

Study Contact

Suzanne Baron, MD, MSc

CONTACT

617) 461-7002

Suzanne.Baron@baiminstitute.org

Ajay Kirtane, MD

CONTACT

(212) 305-7060

ak189@cumc.columbia.edu

Study Locations (Sites)

UAB Structural Heart and Valve Clinic

Birmingham, Alabama, 35233

United States

Banner Health

Phoenix, Arizona, 85012

United States

Honor Health

Scottsdale, Arizona, 13400

United States

UCSF Cardiology

San Francisco, California, 94117

United States

Yale School of Medicine

New Haven, Connecticut, 06510

United States

Saint Luke's

Overland Park, Kansas, 66207

United States

Maine Medical Center

Portland, Maine, 04102

United States

Massachusetts General Hospital

Boston, Massachusetts, 02115

United States

Beth Israel Deaconess Medcial Center

Boston, Massachusetts, 02215

United States

Henry Ford Health

Detroit, Michigan, 48202

United States

Capital Cardiology

Albany, New York, 12211

United States

Columbia Cardiology

New York, New York, 10032

United States

Columbia University Medical Center/ NewYork Presbyterian Hospital

New York, New York, 10032

United States

Christ Hospital

Cincinnati, Ohio, 45219

United States

UPMC

Pittsburgh, Pennsylvania, 15213

United States

Wellspan York Hospital

York, Pennsylvania, 17403

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Baylor Heart and Vascular Hospital

Dallas, Texas, 75226

United States

Houston Methodist

Houston, Texas, 77030

United States

Baylor Scott and White Health

Plano, Texas, 75024

United States

UVA Heart and Vascular Center

Charlottesville, Virginia, 22903

United States

University of Washington

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: Baim Institute for Clinical Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-31

Study Completion Date2025-12-30

Study Record Updates

Study Start Date2023-12-31

Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

Intravascular Lithoplasty
Cutting Balloon
Calcified Coronary Disease
Percutaneous Coronary Intervention

Additional Relevant MeSH Terms

Treatment in Calcified Coronary Disease