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

Primary Purpose

Coronary Heart Disease, Stable Angina Pectoris, Silent Myocardial Ischemia

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Orsiro stents
Resolute Integrity® stents
Sponsored by
Tomsk National Research Medical Center of the Russian Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Orsiro

Resolute Integrity

Arm Description

Implantation of a Orsiro® biolimus a9 eluting coronary stent (drug-eluting stent, DES)

Implantation of a Resolute Integrity® zotarolimus eluting coronary stent (drug-eluting stent, DES)

Outcomes

Primary Outcome Measures

Heterogeneous neointimal healing
Endothelial coverage by Heterogeneous neointima of the stent struts assessed by optical coherence tomography

Secondary Outcome Measures

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

Full Information

First Posted
July 2, 2020
Last Updated
March 3, 2023
Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04465669
Brief Title
Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation
Acronym
Healing
Official Title
Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Stable Angina Pectoris, Silent Myocardial Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Orsiro
Arm Type
Active Comparator
Arm Description
Implantation of a Orsiro® biolimus a9 eluting coronary stent (drug-eluting stent, DES)
Arm Title
Resolute Integrity
Arm Type
Active Comparator
Arm Description
Implantation of a Resolute Integrity® zotarolimus eluting coronary stent (drug-eluting stent, DES)
Intervention Type
Device
Intervention Name(s)
Orsiro stents
Intervention Description
Percutaneous coronary intervention with implantation of either: a Orsiro® biolimus a9 eluting coronary stent
Intervention Type
Device
Intervention Name(s)
Resolute Integrity® stents
Intervention Description
Percutaneous coronary intervention with implantation of either: a Resolute Integrity® zotarolimus eluting coronary stent
Primary Outcome Measure Information:
Title
Heterogeneous neointimal healing
Description
Endothelial coverage by Heterogeneous neointima of the stent struts assessed by optical coherence tomography
Time Frame
4 ± 1 months
Secondary Outcome Measure Information:
Title
Malapposed stent struts
Description
Percentage of malapposed stent struts by optical coherence tomography
Time Frame
4 ± 1 months
Title
Neointimal growth
Description
Neointimal thickness by optical coherence tomography
Time Frame
4 ± 1 months
Title
Angiographic reference vessel diameter
Description
Reference diameter of coronary artery by QCA
Time Frame
4 ± 1 months
Title
Clinical composite endpoints
Description
Cardiac death/Target vessel MI/Clinically indicated TLR All death/All MI/All TVR (including TLR)
Time Frame
12 months
Title
Stent Thrombosis
Description
Definite stent thrombosis
Time Frame
12 months
Title
Uncovered stent struts
Description
Percentage of uncovered stent struts by optical coherence tomography
Time Frame
4 ± 1 months
Title
Angiographic minimal lumen diameter
Description
Minimal lumen diameter of coronary artery by QCA;
Time Frame
4 ± 1 months
Title
Angiographic diameter stenosis
Description
Percent diameter stenosis by QCA;
Time Frame
4 ± 1 months
Title
Binary restenosis
Description
Binary restenosis by QCA;
Time Frame
4 ± 1 months
Title
Angiographic late lumen loss
Description
Late lumen loss by QCA;
Time Frame
4 ± 1 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bessonov S Ivan
Organizational Affiliation
Tyumen Cardiology Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science
City
Tyumen
ZIP/Postal Code
625026
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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