NCT04465669

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Orsiro stents	Percutaneous coronary intervention with implantation of either: a Orsiro® biolimus a9 eluting coronary stent
DEVICE	Resolute Integrity® stents	Percutaneous coronary intervention with implantation of either: a Resolute Integrity® zotarolimus eluting coronary stent

Timeline

• Start date: 2020-01-13
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2020-07-10
• Last updated: 2023-03-06

Locations

1 site across 1 country: Russia