ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2

Study Overview
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Brief Summary
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The ISAR-CALC 2 trial is an investigator-initiated, prospective, randomized, multicenter, assessors-blind, open-label other clinical investigation. The objective of this trial is to investigate final angiographic minimal lumen diameter (MLD) following a strategy of super high-pressure balloon (OPN NC) versus intravascular lithotripsy (IVL) for drug-eluting stent (DES) implantation in severely calcified coronary lesions.

Detailed Description
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Detailed information is provided elsewhere.

Official Title
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Super High-Pressure Balloon Versus Intravascular Lithotripsy for Severely Calcified Coronary Lesions: The ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions (ISAR-CALC) 2 Randomized Trial

Conditions
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Calcified Coronary Artery Disease

Intervention / Treatment
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* Device: Super High Pressure Balloon (OPN NC)
* Device: Intravascular lithotripsy (IVL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 18 years and able to give consent Persistent angina despite medical therapy and/or evidence of inducible ischemia De-novo lesion in a native coronary artery Target reference vessel diameter or intended stent diameter ≥2.50 or ≤4.00 mm by visual estimation Severe calcification of the target lesion as determined by visual estimation at coronary angiography Unsuccessful lesion preparation with standard non-compliant balloon (< 30% reduction of baseline diameter stenosis at maximal pressure) Written informed consent. Exclusion Criteria: Target lesion is located in a coronary artery bypass graft Target lesion is an in-stent restenosis Target lesion is a chronic total occlusion Target vessel thrombus Limited long-term prognosis due to other comorbid conditions with life expectancy <12 months

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Super high-pressure balloon (OPN NC)<br>Patients will be treated with a Super High Pressure percutaneous transluminal coronary angioplasty (PTCA) Balloon (OPN NC). | Device: Super High Pressure Balloon (OPN NC)<br>* Strategy of super high-pressure balloon angioplasty after unsuccessful lesion preparation with conventional NC balloon angioplasty. Optical coherence tomography (OCT) imaging will be performed after lesion preparation with OPN balloon. Optional additional pre-dilatation with OPN/standard NC balloon is permitted at the operator´s discretion. Following lesion preparation, stenting will be performed in the same setting using a latest-generation everolimus-eluting stent (XIENCE; Abbott Vascular, Chicago, IL, USA). Optional post-dilatation with OPN balloon or standard NC balloon is permitted at the operator´s discretion.<br>|
| Experimental: Intravascular lithotripsy (IVL)<br>Patients will be treated with intravascular lithotripsy (IVL). | Device: Intravascular lithotripsy (IVL)<br>* Strategy of IVL after unsuccessful lesion preparation with conventional NC balloon angioplasty. Optical coherence tomography (OCT) imaging will be performed after lesion preparation with IVL balloon. Optional additional pre-dilatation with standard NC balloon is permitted at the operator´s discretion. Following lesion preparation, stenting will be performed in the same setting using a latest-generation everolimus-eluting stent (XIENCE; Abbott Vascular, Chicago, IL, USA). Optional post-dilatation with standard NC balloon is permitted at the operator´s discretion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final angiographic minimal lumen diameter | The primary outcome measure of the trial is the final angiographic minimal lumen diameter as assessed by angiographic core laboratory. | Intraprocedural. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic Success | Defined as target lesion residual angiographic stenosis < 30% in the presence of Thrombolysis in Myocardial Infarction (TIMI) 3 flow. | Intraprocedural. | 
| Procedural Success | Defined as angiographic success without the occurrence of major adverse cardiac event (MACE), a composite of cardiac death, target-vessel related MI and repeat target-vessel revascularization, during index hospitalization. | During index hospitalization, assessed up to 30 days. | 
| Strategy Success | Defined as procedural success using the assigned study device and DES, without requirement for additional devices for lesion preparation; i.e. rotational atherectomy | Intraprocedural. | 
| Acute lumen gain | Defined as minimal lumen diameter (MLD) after balloon angioplasty with the assigned study devices minus baseline MLD. | Intraprocedural. | 
| Complementary lesion preparation | Need for complementary lesion preparation with rotational atherectomy | Intraprocedural. | 
| MACE rates | Occurrence of major adverse cardiac event (MACE) up to 30 days. | 30 days. | 
| Stent expansion as assessed by OCT imaging. | Stent expansion index, defined as minimum stent area divided by mean reference lumen area assessed with OCT imaging. | Intraprocedural. | 
| Cost-effectiveness analysis | Cost-effectiveness analysis of OPN versus IVL in severely calcified coronary lesions treated with DES implantation. | Intraprocedural. |