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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Treatment in Calcified Coronary Disease

Intervention / Treatment
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* Device: Intravascular Lithotripsy
* Device: Cutting Balloon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravascular Lithotripsy<br> | Device: Intravascular Lithotripsy<br>* 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.<br>|
| Active Comparator: Cutting Balloon<br> | Device: Cutting Balloon<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravascular Lithoplasty, Cutting Balloon, Calcified Coronary Disease, Percutaneous Coronary Intervention