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

Coronary Artery Disease Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT01742507
• Study type: Interventional
• Source: The University of Hong Kong
• Status: Completed
• Phase: Phase 4
• Start date: April 2012
• Completion date: August 2016