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

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).

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease; Stable Angina Pectoris; Silent Myocardial Ischemia
• Intervention / Treatment: Device: Orsiro stents; Device: Resolute Integrity® stents

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Tyumen, Russian Federation, 625026
    • Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Investigators: Principal Investigator: Bessonov S Ivan, Tyumen Cardiology Research Center

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia; Angina Pectoris; Angina, Stable
• Other Study ID Numbers: Healing Stent

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No