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

Coronary Heart Disease Clinical Trial

— Healing  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04465669
• Other study ID #: Healing Stent
• Status: Completed
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2022
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Ischemia
• Myocardial Ischemia
• Silent Myocardial Ischemia
• Stable Angina Pectoris

Intervention

Device:
• Orsiro stents
Percutaneous coronary intervention with implantation of either: a Orsiro® biolimus a9 eluting coronary stent
• Resolute Integrity® stents
Percutaneous coronary intervention with implantation of either: a Resolute Integrity® zotarolimus eluting coronary stent

Locations

Country	Name	City	State
Russian Federation	Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science	Tyumen

Sponsors (1)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heterogeneous neointimal healing	Endothelial coverage by Heterogeneous neointima of the stent struts assessed by optical coherence tomography	4 ± 1 months
Secondary	Malapposed stent struts	Percentage of malapposed stent struts by optical coherence tomography	4 ± 1 months
Secondary	Neointimal growth	Neointimal thickness by optical coherence tomography	4 ± 1 months
Secondary	Angiographic reference vessel diameter	Reference diameter of coronary artery by QCA	4 ± 1 months
Secondary	Clinical composite endpoints	Cardiac death/Target vessel MI/Clinically indicated TLR All death/All MI/All TVR (including TLR)	12 months
Secondary	Stent Thrombosis	Definite stent thrombosis	12 months
Secondary	Uncovered stent struts	Percentage of uncovered stent struts by optical coherence tomography	4 ± 1 months
Secondary	Angiographic minimal lumen diameter	Minimal lumen diameter of coronary artery by QCA;	4 ± 1 months
Secondary	Angiographic diameter stenosis	Percent diameter stenosis by QCA;	4 ± 1 months
Secondary	Binary restenosis	Binary restenosis by QCA;	4 ± 1 months
Secondary	Angiographic late lumen loss	Late lumen loss by QCA;	4 ± 1 months