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

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status

Completed

Conditions

Silent Myocardial Ischemia

Coronary Heart Disease

Stable Angina Pectoris

Treatments

Device: Resolute Integrity® stents

Device: Orsiro stents

Study type

Interventional

Funder types

Other

Identifiers

NCT04465669

Healing Stent

Details and patient eligibility

About

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).

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No 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