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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orsiro | Active Comparator | Implantation of a Orsiro® biolimus a9 eluting coronary stent (drug-eluting stent, DES) |
|
| Resolute Integrity | Active Comparator | Implantation of a Resolute Integrity® zotarolimus eluting coronary stent (drug-eluting stent, DES) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orsiro stents | Device | Percutaneous coronary intervention with implantation of either: a Orsiro® biolimus a9 eluting coronary stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heterogeneous neointimal healing | Endothelial coverage by Heterogeneous neointima of the stent struts assessed by optical coherence tomography | 4 ± 1 months |
| Measure | Description | Time Frame |
|---|---|---|
| Malapposed stent struts | Percentage of malapposed stent struts by optical coherence tomography | 4 ± 1 months |
| Neointimal growth | Neointimal thickness by optical coherence tomography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bessonov S Ivan | Tyumen Cardiology Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science | Tyumen | 625026 | Russia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 3, 2020 | Aug 10, 2020 |
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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).
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| Resolute Integrity® stents | Device | Percutaneous coronary intervention with implantation of either: a Resolute Integrity® zotarolimus eluting coronary stent |
|
| 4 ± 1 months |
| Angiographic reference vessel diameter | Reference diameter of coronary artery by QCA | 4 ± 1 months |
| Clinical composite endpoints | Cardiac death/Target vessel MI/Clinically indicated TLR All death/All MI/All TVR (including TLR) | 12 months |
| Stent Thrombosis | Definite stent thrombosis | 12 months |
| Uncovered stent struts | Percentage of uncovered stent struts by optical coherence tomography | 4 ± 1 months |
| Angiographic minimal lumen diameter | Minimal lumen diameter of coronary artery by QCA; | 4 ± 1 months |
| Angiographic diameter stenosis | Percent diameter stenosis by QCA; | 4 ± 1 months |
| Binary restenosis | Binary restenosis by QCA; | 4 ± 1 months |
| Angiographic late lumen loss | Late lumen loss by QCA; | 4 ± 1 months |
| Prot_001.pdf |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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