A Study Comparing Two Stent on the Degree of Early Stent Healing and Late Lumen Loss.The OCT-ORION Study (OCT-ORION)
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.
|Coronary Artery Disease||Device: Resolute Integrity Stent Device: Biomatrix stent||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- • OCT derived percentage stent strut coverage at 9 month [ Time Frame: 9 month ]OCT derived percentage stent strut coverage at 9 month
- Angiographic binary stenosis [ Time Frame: 9 month ]• Angiographic binary stenosis at 9 month
- • OCT derived neo-intimal area at 9 month [ Time Frame: at 9 month ]• OCT derived neo-intimal area 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
- • 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.
- • 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
- Percentage of stent strut malapposition [ Time Frame: 9 month ]Percentage of stent strut malapposition
- Mean neo-intimal thickness (NIT) at 9 month [ Time Frame: 9 month ]Mean neo-intimal thickness (NIT) at 9 month
- Stent volume [ Time Frame: at 9 month ]Stent volume
- Lumen volume [ Time Frame: at 9 month ]Lumen volume
- Neointimal Hyperplasia (NIH) volume [ Time Frame: at 9 month ]Neointimal Hyperplasia (NIH) volume
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Medtronic Resolute Integrity Stent
Medtronic Resolute Integrity Stent
Device: Resolute Integrity Stent
Resolute Integrity Stent
Active Comparator: Biomatrix stent
Device: Biomatrix stent
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742507
|Division of Cardiology, Department of Medicine, QMH|
|Hong Kong, Hong Kong|
|Principal Investigator:||Stephen Wai Luen LEE, MD FRCP FACC||Queen Mary Hosptial, The Univeristy of Hong Kong|