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

Primary Purpose

Treatment in Calcified Coronary Disease

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Intravascular Lithotripsy
Cutting Balloon
Sponsored by
Baim Institute for Clinical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment in Calcified Coronary Disease focused on measuring Intravascular Lithoplasty, Cutting Balloon, Calcified Coronary Disease, Percutaneous Coronary Intervention

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 Exclusion Criteria: 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 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Intravascular Lithotripsy

    Cutting Balloon

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Procedural Cost
    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
    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)
    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)
    Peri-procedural Myocardial Infarction
    Peri-procedural Myocardial Infarction as defined by Academic Research Consortium-2
    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.
    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

    Full Information

    First Posted
    October 6, 2023
    Last Updated
    October 16, 2023
    Sponsor
    Baim Institute for Clinical Research
    Collaborators
    Robert W. Yeh, MD, Ajay Kirtane, MD, C. Michael Gibson, MS, MD, Kathleen Kearney, MD, Akiko Maehara, MD, Suzanne Baron, MD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06089135
    Brief Title
    Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial
    Acronym
    Short-Cut
    Official Title
    Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial (Short-Cut)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 31, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2024 (Anticipated)
    Study Completion Date
    November 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Baim Institute for Clinical Research
    Collaborators
    Robert W. Yeh, MD, Ajay Kirtane, MD, C. Michael Gibson, MS, MD, Kathleen Kearney, MD, Akiko Maehara, MD, Suzanne Baron, MD

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Treatment in Calcified Coronary Disease
    Keywords
    Intravascular Lithoplasty, Cutting Balloon, Calcified Coronary Disease, Percutaneous Coronary Intervention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    410 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intravascular Lithotripsy
    Arm Type
    Active Comparator
    Arm Title
    Cutting Balloon
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Intravascular Lithotripsy
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Cutting Balloon
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Primary Endpoint
    Description
    Post-procedural stent area at the point of maximum calcification as measured by intravascular imaging
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Procedural Cost
    Time Frame
    Index procedure
    Title
    Procedural success
    Description
    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
    Title
    Angiographic success
    Description
    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
    Title
    Strategy success
    Description
    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
    Title
    Peri-procedural Myocardial Infarction
    Description
    Peri-procedural Myocardial Infarction as defined by Academic Research Consortium-2
    Time Frame
    within 48 hours of index procedure
    Title
    In-hospital MACCE
    Description
    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.
    Time Frame
    hospitalization
    Title
    30 Day MACCE
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 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 Exclusion Criteria: 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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Suzanne Baron, MD, MSc
    Phone
    617) 461-7002
    Email
    Suzanne.Baron@baiminstitute.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ajay Kirtane, MD
    Phone
    (212) 305-7060
    Email
    ak189@cumc.columbia.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33441017
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    36262074
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22562910
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30354632
    Citation
    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. Erratum In: Circ Cardiovasc Interv. 2018 Oct;11(10):e000040.
    Results Reference
    background
    PubMed Identifier
    36841945
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    37676225
    Citation
    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 Aug 8:S1936-8798(23)01051-8. doi: 10.1016/j.jcin.2023.07.010. Online ahead of print. No abstract available.
    Results Reference
    background

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

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