Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Coronary Heart Disease
- Silent Myocardial Ischemia
- Stable Angina Pectoris
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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: Single (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 Ca...
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.
Tracking Information
- NCT #
- NCT04465669
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Bessonov S Ivan Tyumen Cardiology Research Center
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