This trial is active, not recruiting.

Condition coronary artery disease
Treatments resolute integrity stent, biomatrix stent
Phase phase 4
Sponsor The University of Hong Kong
Start date April 2012
End date August 2016
Trial size 60 participants
Trial identifier NCT01742507, UW 12-093


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Medtronic Resolute Integrity Stent
resolute integrity stent
Resolute Integrity Stent
(Active Comparator)
Biomatrix stent
biomatrix stent
Biomatrix stent

Primary Outcomes

• OCT derived percentage stent strut coverage at 9 month
time frame: 9 month

Secondary Outcomes

Angiographic binary stenosis
time frame: 9 month
• OCT derived neo-intimal area at 9 month
time frame: at 9 month
• Minimal lumen diameter by Quantitative Coronary Analysis (QCA) at 9 month
time frame: 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
• Target vessel stent thrombosis per Academic Research Consortium (ARC) definition
time frame: from enrollment till 2 years follow up
Percentage of stent strut malapposition
time frame: 9 month
Mean neo-intimal thickness (NIT) at 9 month
time frame: 9 month
Stent volume
time frame: at 9 month
Lumen volume
time frame: at 9 month
Neointimal Hyperplasia (NIH) volume
time frame: at 9 month

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

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
Principal investigator Stephen Wai Luen LEE, MD FRCP FACC
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by The University of Hong Kong.