A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions

Study Overview
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Brief Summary
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The objective of this prospective, multicenter, randomized, open-label trial is to evaluate the completeness of stent expansion following a strategy of lesion preparation with either a Super High-Pressure NC PTCA Balloon (OPN NC) or a Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty in an angiographically well-defined group of patients with severely calcified coronary lesions (grade 3) undergoing coronary stent implantation (SYNERGY everolimus-eluting stent (EES)).

Official Title
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A ComparIson of Strategies to Prepare Severely Calcified Coronary Lesions - A Prospective Randomized Controlled Trial of Super High-Pressure NC PTCA Balloon Versus Scoring PTCA Balloon in Severely Calcified Coronary Lesions

Conditions
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Calcified Coronary Artery Disease (Grade 3)

Intervention / Treatment
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* Device: Super High-Pressure NC PTCA Balloon (OPN NC)
* Device: Scoring PTCA Balloon (NSE Alpha)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 18 years and consentable; Persistent angina symptoms despite optimal medical therapy and/or evidence of inducible ischemia; Angiographically-proven coronary artery disease; De novo lesion in a native coronary artery; Target reference vessel diameter between 2.25 and 4.00 mm by visual estimation; Calcification of the target lesion as determined by angiography (grade 3); Unsuccessful lesion preparation (<30% reduction of baseline diameter stenosis) with conventional NC balloon angioplasty Written informed consent. Exclusion Criteria: Myocardial infarction (within 1 week); Limited long-term prognosis due to other conditions; Target lesion is in a coronary artery bypass graft; Target lesion is an in-stent restenosis; Target lesion is aorto-ostial; Target vessel thrombus.

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: OPN NC<br>Patients receiving a Super High-Pressure NC PTCA Balloon (OPN NC) | Device: Super High-Pressure NC PTCA Balloon (OPN NC)<br>* Strategy of Super High-Pressure NC PTCA Balloon (OPN NC) after unsuccessful lesion preparation with conventional NC balloon angioplasty.<br>|
| Experimental: NSE Alpha<br>Patients receiving a Scoring PTCA Balloon (NSE Alpha) | Device: Scoring PTCA Balloon (NSE Alpha)<br>* Strategy of Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent expansion index (SEI) | Stent expansion index (SEI), defined as minimum stent area divided by mean reference area in an optical coherence tomography (OCT) quantitative analysis | intraprocedural | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic Success | 'Angiographic Success', defined as the achievement of residual angiographic stenosis <30% of the target lesion in the presence of TIMI 3 flow | intraprocedural | 
| Procedural Success | 'Procedural Success', defined as the achievement of angiographic success without any MACE, defined as cardiac death, target vessel related myocardial infarction and repeat revascularization (PTCA/PCI or coronary artery bypass graft [CABG]) | 30 days | 
| Strategy Success | 'Strategy Success' defined as procedural success using the assigned study device and stent, without requirement for lesion preparations with further devices (i.e. rotational atherectomy [RA]) | intraprocedural | 
| Acute lumen gain, | Acute lumen gain, defined as minimal lumen diameter (MLD) post balloon angioplasty minus baseline MLD (mm) | intraprocedural | 
| Complementary lesion preparations | Number of complementary lesion preparations with further devices (i.e. rotational atherectomy [RA]) | intraprocedural | 
| Rate of vessel perforation | Rate of vessel perforation | intraprocedural | 
| Procedure duration | Procedure duration in min | intraprocedural | 
| Contrast volume | Contrast volume in mL | intraprocedural |