Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation

Study Overview
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Brief Summary
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The objective of this study is a comparative evaluation of Orsiro stent and of Resolute Integrity stent in terms of the extent of neointima formation at 4 months after implantation using optical coherence tomography (OCT).

Detailed Description
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About 50 patients with clinical evidence of ischemic heart disease and / or a positive functional study and documented stable angina pectoris (Canadian cardiovascular society classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native, previously unstented vessel in Tyumen Cardiology Center,will be randomly assigned undergoing implantation of Orsiro stent or Resolute Integrity stent (in a 1:1 ratio). All of the patients will receive 12 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 1 year. The follow-up visits will be conducted at 4 months (including angiographic/OCT investigation), and 1 year post percutaneous coronary intervention(PCI),in order to observe the Primary Endpoint and Secondary Endpoints.

Official Title
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Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation

Conditions
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Coronary Heart Disease, Stable Angina Pectoris, Silent Myocardial Ischemia

Intervention / Treatment
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* Device: Orsiro stents
* Device: Resolute Integrity® stents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years; Patients with symptoms of stable angina and/or presence of a positive functional test for ischemia; Patient is eligible for percutaneous coronary intervention (PCI); Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site. Exclusion Criteria: Target lesion involving a bifurcation with a side branch ≥2.0 mm in diameter; Target lesion located in the left main stem; Target lesion is located or supplied by an arterial or venous bypass graft; Lesion located very distally, difficult to be imaged by OCT; Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year; Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study; Patient underwent target vessel revascularization with a DES; Patient presenting with acute myocardial infarction with ST elevation; Cerebrovascular accident within the past 12 months; Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl); Patient receiving oral anticoagulants

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
Interventional Model Description: About 50 patients with clinical evidence of ischemic heart disease and / or a positive functional study and documented stable angina pectoris (Canadian cardiovascular society classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native, previously unstented vessel in Tyumen Cardiology Center,will be randomly assigned undergoing implantation of Orsiro stent or Resolute Integrity stent (in a 1:1 ratio).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Orsiro<br>Implantation of a Orsiro® biolimus a9 eluting coronary stent (drug-eluting stent, DES) | Device: Orsiro stents<br>* Percutaneous coronary intervention with implantation of either: a Orsiro® biolimus a9 eluting coronary stent<br>|
| Active Comparator: Resolute Integrity<br>Implantation of a Resolute Integrity® zotarolimus eluting coronary stent (drug-eluting stent, DES) | Device: Resolute Integrity® stents<br>* Percutaneous coronary intervention with implantation of either: a Resolute Integrity® zotarolimus eluting coronary stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heterogeneous neointimal healing | Endothelial coverage by Heterogeneous neointima of the stent struts assessed by optical coherence tomography | 4 ± 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malapposed stent struts | Percentage of malapposed stent struts by optical coherence tomography | 4 ± 1 months | 
| Neointimal growth | Neointimal thickness by optical coherence tomography | 4 ± 1 months | 
| Angiographic reference vessel diameter | Reference diameter of coronary artery by QCA | 4 ± 1 months | 
| Clinical composite endpoints | Cardiac death/Target vessel MI/Clinically indicated TLR All death/All MI/All TVR (including TLR) | 12 months | 
| Stent Thrombosis | Definite stent thrombosis | 12 months | 
| Uncovered stent struts | Percentage of uncovered stent struts by optical coherence tomography | 4 ± 1 months | 
| Angiographic minimal lumen diameter | Minimal lumen diameter of coronary artery by QCA; | 4 ± 1 months | 
| Angiographic diameter stenosis | Percent diameter stenosis by QCA; | 4 ± 1 months | 
| Binary restenosis | Binary restenosis by QCA; | 4 ± 1 months | 
| Angiographic late lumen loss | Late lumen loss by QCA; | 4 ± 1 months |