Clinical trial NCT04465669: Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation
Official title: Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Stable Angina Pectoris
Silent Myocardial Ischemia
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Heterogeneous neointimal healing
timeFrame: 4 ± 1 months
Secondary outcomes:
measure: Malapposed stent struts
timeFrame: 4 ± 1 months
measure: Neointimal growth
timeFrame: 4 ± 1 months
measure: Angiographic reference vessel diameter
timeFrame: 4 ± 1 months
measure: Clinical composite endpoints
timeFrame: 12 months
measure: Stent Thrombosis
timeFrame: 12 months
measure: Uncovered stent struts
timeFrame: 4 ± 1 months
measure: Angiographic minimal lumen diameter
timeFrame: 4 ± 1 months
measure: Angiographic diameter stenosis
timeFrame: 4 ± 1 months
measure: Binary restenosis
timeFrame: 4 ± 1 months
measure: Angiographic late lumen loss
timeFrame: 4 ± 1 months
Other outcomes:
Locations:
city: Tyumen
country: Russian Federation
facility: Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science
Study officials:
affiliation: Tyumen Cardiology Research Center
name: Bessonov S Ivan
role: PRINCIPAL_INVESTIGATOR
References: