Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04465669
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Tomsk National Research Medical Center of the Russian Academy of Sciences

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 3 months after implantation using optical coherence tomography (OCT).

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Stable Angina Pectoris Silent Myocardial Ischemia Device: Orsiro stents Device: Resolute Integrity® stents Not Applicable

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 3 months (including angiographic/OCT investigation), and 1 year post percutaneous coronary intervention(PCI),in order to observe the Primary Endpoint and Secondary Endpoints.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Active Comparator: Orsiro
Implantation of a Orsiro® biolimus a9 eluting coronary stent (drug-eluting stent, DES)
Device: Orsiro stents

Percutaneous coronary intervention with implantation of either:

a Orsiro® biolimus a9 eluting coronary stent


Active Comparator: Resolute Integrity
Implantation of a Resolute Integrity® zotarolimus eluting coronary stent (drug-eluting stent, DES)
Device: Resolute Integrity® stents

Percutaneous coronary intervention with implantation of either:

a Resolute Integrity® zotarolimus eluting coronary stent





Primary Outcome Measures :
  1. Heterogeneous neointimal healing [ Time Frame: 3 months ]
    Endothelial coverage by Heterogeneous neointima of the stent struts assessed by optical coherence tomography


Secondary Outcome Measures :
  1. Malapposed stent struts [ Time Frame: 3 months ]
    Percentage of malapposed stent struts by optical coherence tomography

  2. Neointimal growth [ Time Frame: 3 months ]
    Neointimal thickness by optical coherence tomography

  3. Angiographic reference vessel diameter [ Time Frame: 3 months ]
    Reference diameter of coronary artery by QCA

  4. Clinical composite endpoints [ Time Frame: 12 months ]
    Cardiac death/Target vessel MI/Clinically indicated TLR All death/All MI/All TVR (including TLR)

  5. Stent Thrombosis [ Time Frame: 12 months ]
    Definite stent thrombosis

  6. Uncovered stent struts [ Time Frame: 3 months ]
    Percentage of uncovered stent struts by optical coherence tomography

  7. Angiographic minimal lumen diameter [ Time Frame: 3 months ]
    Minimal lumen diameter of coronary artery by QCA;

  8. Angiographic diameter stenosis [ Time Frame: 3 months ]
    Percent diameter stenosis by QCA;

  9. Binary restenosis [ Time Frame: 3 months ]
    Binary restenosis by QCA;

  10. Angiographic late lumen loss [ Time Frame: 3 months ]
    Late lumen loss by QCA;



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04465669


Contacts
Layout table for location contacts
Contact: Stanislav Sapozhnikov +79091919191 stas_ss@bk.ru

Locations
Layout table for location information
Russian Federation
Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science Recruiting
Tyumen, Russian Federation, 625026
Contact: Stanislav S Sapozhnikov    +79091919191    stas_ss@bk.ru   
Contact: Ivan S Bessonov    +79068237755    ivanbessnv@gmail.com   
Sponsors and Collaborators
Tomsk National Research Medical Center of the Russian Academy of Sciences
Investigators
Layout table for investigator information
Principal Investigator: Bessonov S Ivan Tyumen Cardiology Research Center
  Study Documents (Full-Text)

Documents provided by Tomsk National Research Medical Center of the Russian Academy of Sciences:
Study Protocol  [PDF] January 13, 2020

Layout table for additonal information
Responsible Party: Tomsk National Research Medical Center of the Russian Academy of Sciences
ClinicalTrials.gov Identifier: NCT04465669    
Other Study ID Numbers: Healing Stent
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Coronary Disease
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Myocardial Ischemia
Angina Pectoris
Angina, Stable
Ischemia
Pathologic Processes
Arteriosclerosis
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms