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

Not Applicable

Completed

• Conditions: Silent Myocardial Ischemia; Coronary Heart Disease; Stable Angina Pectoris
• Interventions: Device: Resolute Integrity® stents; Device: Orsiro stents

• Registration Number: NCT04465669
• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-01-13
• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-10
• Primary Completion: 2021-12-31
• Status Verified: 2022-10
• Study Completion: 2022-12-31
• Last Update Submitted: 2023-03-03
• Last Update Posted: 2023-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resolute Integrity	Resolute Integrity® stents	Implantation of a Resolute Integrity® zotarolimus eluting coronary stent (drug-eluting stent, DES)
Orsiro	Orsiro stents	Implantation of a Orsiro® biolimus a9 eluting coronary stent (drug-eluting stent, DES)

Primary Outcome Measures

Name	Time	Method
Heterogeneous neointimal healing	4 ± 1 months	Endothelial coverage by Heterogeneous neointima of the stent struts assessed by optical coherence tomography

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science; 🇷🇺 Tyumen, Russian Federation