A Study Comparing Two Stent on the Degree of Early Stent Healing and Late Lumen Loss.The OCT-ORION Study (OCT-ORION)

July 24, 2017 updated by: Professor Stephen Lee, The University of Hong Kong

A Randomized Optical Coherence Tomography Study Comparing Resolute Integrity to Biomatrix Drug-eluting Stent on the Degree of Early Stent Healing and Late Lumen Loss.The OCT-ORION Study

Stent coverage and neo-intimal growth can be evaluated in-detail by intracoronary optical coherence tomography (OCT), which is a catheter-based imaging technique. It is performed as part of the PCI procedure. OCT is the optical analogue of intravascular ultrasound (IVUS), except that it can provide much higher resolution of coronary cross sectional images than IVUS. The LightLab C7XR OCT system (Frequency Domain OCT) used in this Hospital has obtained full CE Mark, approved by the US FDA, and approved for clinical use in Hong Kong. It has been shown to be safe in clinical settings and has been used in over 300 patients without complication at Queen Mary Hospital.

In this study, stent coverage and neo-intimal growth between zotarolimus-eluting stents (ZES) and biolimus-eluting stents (BES) will be compared by using OCT at 9 month and specific post-intervention re-study intervals.

The investigators objective is to investigate the clinical impact and OCT difference on early stent healing and late lumen loss between the two new-generation limus-eluting-stents - Resolute Integrity and Biomatrix, which differ in stent design, eluting drug and coating polymer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomised, assessor-blinded, single centre study. Patients with symptomatic coronary artery diseases in 2 or 3 coronary vessels requiring PCI are eligible for the study. PCI will be performed in the usual manner to all the study lesions in the same procedure. In a randomized fashion, each patient will have one artery with critical disease(s) treated by the Resolute Integrity Stent(s) and the other artery treated by the Biomatrix Stent(s).

Baseline OCT data will be obtained right after stenting. The remaining coronary artery, if diseased and required PCI treatment, will be treated during the angiographic and OCT follow-up as a staged procedure. Patients will be randomly assigned into 5 groups with equal number, receiving a follow-up coronary angiogram with OCT from 2, 3, 4, 5 and 6 months interval post-intervention. Each patient will serve as his/her own control comparing the 2 types of stents. At 9-month post-intervention, all patients will receive a second follow-up coronary angiogram with OCT. All OCT data analyses will be performed in a blinded fashion by a core laboratory. Phone follow up will be carried out for cardiac events at 1 year and 2 year of post intervention.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Division of Cardiology, Department of Medicine, QMH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient aged 18-85 years old
  • Patient with symptomatic coronary artery diseases involving two or more vessels requiring percutaneous coronary intervention

Exclusion Criteria:

  • Patient who is unable to give consent
  • Patient in acute myocardial infarction or unstable angina
  • Patient who is hemodynamically unstable
  • Patient who is allergic to contrast agents
  • Patient who is allergic to anti-platelet agents
  • Patient who is allergic to zotarolimus
  • Patient who is allergic to biolimus
  • Patient who is pregnant
  • Patient who has planned surgery in the following 12 months after percutaneous coronary intervention
  • Left main coronary lesion
  • Bifurcation lesion
  • Chronic total occlusion lesion
  • Coronary vessel size smaller than 2.5mm
  • Coronary lesion longer than 38mm in length

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Medtronic Resolute Integrity Stent
Device: Resolute Integrity Stent
Resolute Integrity Stent
Active Comparator: Biomatrix stent
Device: Biomatrix stent
Biomatrix stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• OCT derived percentage stent strut coverage at 9 month
Time Frame: 9 month
OCT derived percentage stent strut coverage at 9 month
9 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angiographic binary stenosis
Time Frame: 9 month
• Angiographic binary stenosis at 9 month
9 month
• OCT derived neo-intimal area at 9 month
Time Frame: at 9 month
• OCT derived neo-intimal area at 9 month
at 9 month
• Minimal lumen diameter by Quantitative Coronary Analysis (QCA) at 9 month
Time Frame: 9 month
• Minimal lumen diameter by Quantitative Coronary Analysis (QCA) at 9 month
9 month
• All major adverse cardiac events (all cardiac deaths, myocardial infarction, target vessel failure and target lesion revascularization, and stent thrombosis) at the pre-defined 2 to 9 months angiographic and OCT follow-up.
Time Frame: 2 to 9 months
• All major adverse cardiac events (all cardiac deaths, myocardial infarction, target vessel failure and target lesion revascularization, and stent thrombosis) at the pre-defined 2 to 9 months angiographic and OCT follow-up.
2 to 9 months
• Target vessel stent thrombosis per Academic Research Consortium (ARC) definition
Time Frame: from enrollment till 2 years follow up
• Target vessel stent thrombosis per Academic Research Consortium (ARC) definition
from enrollment till 2 years follow up
Percentage of stent strut malapposition
Time Frame: 9 month
Percentage of stent strut malapposition
9 month
Mean neo-intimal thickness (NIT) at 9 month
Time Frame: 9 month
Mean neo-intimal thickness (NIT) at 9 month
9 month
Stent volume
Time Frame: at 9 month
Stent volume
at 9 month
Lumen volume
Time Frame: at 9 month
Lumen volume
at 9 month
Neointimal Hyperplasia (NIH) volume
Time Frame: at 9 month
Neointimal Hyperplasia (NIH) volume
at 9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Stephen Wai Luen LEE, MD FRCP FACC, Queen Mary Hosptial, The Univeristy of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

March 22, 2012

First Submitted That Met QC Criteria

December 3, 2012

First Posted (Estimate)

December 5, 2012

Study Record Updates

Last Update Posted (Actual)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 24, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 12-093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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