Status:
COMPLETED
Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation
Lead Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Conditions:
Coronary Heart Disease
Stable Angina Pectoris
Eligibility:
All Genders
18+ years
Phase:
NA
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 coher...
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04465669
Start Date
January 13 2020
End Date
December 31 2022
Last Update
March 6 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science
Tyumen, Russia, 625026