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

NCT04465669 | Completed DMC

• 1 other identifier: Healing Stent
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 coherence tomography (OCT).

Conditions

Coronary Heart Disease; Stable Angina Pectoris; Silent Myocardial Ischemia

Outcome Measures

Primary Outcomes (1)

• Heterogeneous neointimal healing

  Endothelial coverage by Heterogeneous neointima of the stent struts assessed by optical coherence tomography

  4 ± 1 months

Secondary Outcomes (10)

• Malapposed stent struts

  4 ± 1 months

• Neointimal growth

  4 ± 1 months

• Angiographic reference vessel diameter

  4 ± 1 months

• Clinical composite endpoints

  12 months

• Stent Thrombosis

  12 months

Study Arms (2)

Orsiro

ACTIVE COMPARATOR

Implantation of a Orsiro® biolimus a9 eluting coronary stent (drug-eluting stent, DES)

Device: Orsiro stents

Resolute Integrity

ACTIVE COMPARATOR

Implantation of a Resolute Integrity® zotarolimus eluting coronary stent (drug-eluting stent, DES)

Device: Resolute Integrity® stents

Interventions

Orsiro stents DEVICE

Percutaneous coronary intervention with implantation of either: a Orsiro® biolimus a9 eluting coronary stent

Orsiro

Resolute Integrity® stents DEVICE

Percutaneous coronary intervention with implantation of either: a Resolute Integrity® zotarolimus eluting coronary stent

Resolute Integrity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science

Tyumen, 625026, Russia

Location

MeSH Terms

Conditions

Coronary Disease; Angina, Stable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bessonov S Ivan

  Tyumen Cardiology Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 10, 2020
• Study Start: January 13, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: March 6, 2023

Record last verified: 2022-10

Locations

RU (1)