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

NCT ID: NCT04465669

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-13
• Study Completion Date: 2022-12-31

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.

Conditions

Coronary Heart Disease; Stable Angina Pectoris; Silent Myocardial Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Orsiro

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

Group Type: ACTIVE_COMPARATOR

Orsiro stents

Intervention Type: DEVICE

Percutaneous coronary intervention with implantation of either:

a Orsiro® biolimus a9 eluting coronary stent

Resolute Integrity

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

Group Type: ACTIVE_COMPARATOR

Resolute Integrity® stents

Intervention Type: DEVICE

Percutaneous coronary intervention with implantation of either:

a Resolute Integrity® zotarolimus eluting coronary stent

Interventions

Orsiro stents

Percutaneous coronary intervention with implantation of either:

a Orsiro® biolimus a9 eluting coronary stent

Intervention Type: DEVICE

Resolute Integrity® stents

Percutaneous coronary intervention with implantation of either:

a Resolute Integrity® zotarolimus eluting coronary stent

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tomsk National Research Medical Center of the Russian Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bessonov S Ivan

Role: PRINCIPAL_INVESTIGATOR

Tyumen Cardiology Research Center

Locations

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

Tyumen, , Russia

Countries

Russia

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

Healing Stent

Identifier Type: -

Identifier Source: org_study_id