Vessel Injury in Relation With Strut Thickness Assessed by OCT

Study Overview
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Brief Summary
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The objective of the present study is to determine the relation between vascular injury induced by the stent and strut thickness.

Detailed Description
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Thinner struts produce less arterial injury after stent implantation.The objective of the present study is to determine the relation between vascular injury induced by the stent and strut thickness. Vessel injury after stent implantation will be evaluated with optical coherence tomography (OCT). Two stents platforms with different strut thickness (Coroflex ISAR 50 microns and Biomatrix 120 microns) will be compared.

Official Title
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Vessel Injury in Relation With Strut Thickness Assessed by OCT (VISTA): A Comparison of Vascular Injury Induced by a Polymer Free Sirolimus and Probucol Eluting Stent and a Biodegradable-polymer Biolimus-eluting Stent

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Polymer-free stent
* Device: Biodegradable-polymer stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years Ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of >50% de novo stenosis located in native coronary vessels Exclusion Criteria: Target lesion located in the left main stem STEMI Restenosis Cardiogenic shock Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol noncompliance Known allergy to the study medications (probucol, sirolimus, zotarolimus) Pregnancy (present, suspected, or planned)

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coroflex ISAR stent<br>PCI with a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR stent) with very thin struts (50 µm). During the PCI, an OCT assessment (baseline and post-implantation) will be performed. | Device: Polymer-free stent<br>* PCI using a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR)<br>* Other names: Coroflex ISAR;|
| Active Comparator: Biomatrix stent<br>PCI with a biodegradable-polymer biolimus-eluting stent (Biomatrix stent) with 120 µm struts. During the PCI, an OCT assessment (baseline and post-implantation) will be performed. | Device: Biodegradable-polymer stent<br>* PCI using a biodegradable-polymer biolimus-eluting stent (Biomatrix)<br>* Other names: Biomatrix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT-based intimal injury score | OCT-based intimal injury score estimated after implantation of the Coroflex-ISAR and Biomatrix DES | Up to 1 day (evaluated after stent implantation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue prolapse area | Tissue prolapse area assessed by OCT after implantation of Coroflex-ISAR and Biomatrix will be measured | Up to 1 day (evaluated after stent implantation) | 
| Incidence of stent malapposition | Stent apposition after implantation of Coroflex-ISAR and Biomatrix as assessed by OCT | Up to 1 day (evaluated after stent implantation) | 
| Incidence of stent underexpansion | Stent expansion will be measured with OCT after implantation of Coroflex-ISAR and Biomatrix | Up to 1 day (evaluated after stent implantation) | 
| Stent symmetry after implantation | Stent symmetry will be measured with OCT after implantation of Coroflex-ISAR and Biomatrix | Up to 1 day (evaluated after stent implantation) | 
| Baseline plaque type | Baseline plaque type will be assessed by OCT (fibrous, fibrocalcific or lipid-rich) | Up to 1 day (evaluated after stent implantation) |