A Study to Examine the Implantation Characteristics of Two Drug-Eluting Stents (ORCA-2)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Coronary Stent Cypher
Coronary stent Xience
Sponsored by

About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Percutaneous Coronary Intervention, Coronary Artery Stenosis, Acute Myocardial Infarction, Coronary Artery Stent, Optical Coherence Tomography
Eligibility Criteria
Inclusion Criteria:
- Presence of a coronary artery stenosis undergoing percutaneous coronary intervention and stenting (PCI).
- Eligibility for drug eluting stent (DES) deployment.
- Stable or unstable coronary syndrome presentation, including ST elevation myocardial infarction (STEMI).
- Aged 18-90
Exclusion Criteria:
- Contraindication to the use of a DES.
- Target lesion located within previous stent (in stent restenosis).
- Sustained haemodynamic instability following stent deployment (Systolic BP 90≤ mmHg or sustained ventricular arrhythmia).
Sites / Locations
- Harefield Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cypher™ Stent
Xience™ Stent
Arm Description
Participants in the Cypher arm will be randomised to receive a Cypher™ (Cordis, Miami Lake, USA) coronary stent
Patients in the Xience™ arm will receive a Xience™ Stent(Abbott Vascular, Santa Clara, USA.
Outcomes
Primary Outcome Measures
Stent strut malapposition (SSM)
SSM will be quoted as the percentage of malapposed stent struts as a proportion of the total number of struts analysed within each stent group.
Secondary Outcome Measures
Stent eccentricity index (SEI)
This is a commonly used measure that is designed to quantify the uniformity and symmetry of the stent after it has been deployed in the coronary artery. It is calculated as the minimum diameter of the stent divided by the maximum diameter of the stent at a preset point. The mean SEI will be compared between two stent type groups.
Degree of stent embedding
This relates to what degree, if at all, the stent strut is 'buried' within the coronary artery wall. The proportion of each strut that is buried or embedded will be calculated and then averaged for each stent group. A strut that is buried in the vessel wall for more than half its thickness will be defined as 'embedded'.
Full Information
NCT ID
NCT01201369
First Posted
August 24, 2010
Last Updated
July 11, 2011
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01201369
Brief Title
A Study to Examine the Implantation Characteristics of Two Drug-Eluting Stents
Acronym
ORCA-2
Official Title
Comparison of Rates of Strut Malapposition Between Everolimus and Sirolimus Eluting Stents - A Randomised Optical Coherence Tomography Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Despite recent advances in stent technology and clot reducing drug therapy, acute stent occlusion or thrombosis (ST), still occurs and can be life threatening. It has been shown that certain features of how the stent relates to the artery wall may predict ST. One such feature, so-called stent strut malapposition (SSM), can be assessed after implantation but current imaging techniques are relatively unreliable. Optical Coherence Tomography (OCT) is a newer technology that can be performed safely and easily after angioplasty and may allow the stent struts to be assessed more accurately and reliably.
This study will use OCT to examine how two different types of commonly used drug-eluting stents relate to the artery wall. The Xience V (Abbott Vascular, USA) stent has thinner struts and a more open frame than the Cypher (Cordis, USA) stent. We hypothesise therefore that the potentially more pliable structure of the Xience V stent will be associated with greater contact with the vessel wall. This may have a bearing on the relative rate of SSM, although large studies have shown the rate to be low in both the Cypher and the Xience V stent. We believe that OCT imaging of SSM and symmetry of the stent immediately after angioplasty will compliment conventional visual assessment and may identify those patients in whom further improvement of stent with a balloon is necessary.
This study will involve the random allocation of forty patients requiring coronary angioplasty to one of the Cypher or Xience V stent. The procedure will be performed in the usual manner as indicated clinically and will include imaging of the stented artery segment with OCT once the operator is satisfied with the visual result by angiography.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Percutaneous Coronary Intervention, Coronary Artery Stenosis, Acute Myocardial Infarction, Coronary Artery Stent, Optical Coherence Tomography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cypher™ Stent
Arm Type
Active Comparator
Arm Description
Participants in the Cypher arm will be randomised to receive a Cypher™ (Cordis, Miami Lake, USA) coronary stent
Arm Title
Xience™ Stent
Arm Type
Active Comparator
Arm Description
Patients in the Xience™ arm will receive a Xience™ Stent(Abbott Vascular, Santa Clara, USA.
Intervention Type
Device
Intervention Name(s)
Coronary Stent Cypher
Intervention Description
The angioplasty will then be performed in a usual fashion in accordance with the operator's discretion and local protocols.
Intervention Type
Device
Intervention Name(s)
Coronary stent Xience
Intervention Description
The angioplasty will then be performed in a usual fashion in accordance with the operator's discretion and local protocols
Primary Outcome Measure Information:
Title
Stent strut malapposition (SSM)
Description
SSM will be quoted as the percentage of malapposed stent struts as a proportion of the total number of struts analysed within each stent group.
Time Frame
Immediate post stent deployment during the same angiographic procedure within 60 minutes
Secondary Outcome Measure Information:
Title
Stent eccentricity index (SEI)
Description
This is a commonly used measure that is designed to quantify the uniformity and symmetry of the stent after it has been deployed in the coronary artery. It is calculated as the minimum diameter of the stent divided by the maximum diameter of the stent at a preset point. The mean SEI will be compared between two stent type groups.
Time Frame
Immediate post stent deployment during the same angiographic procedure within 60 minutes
Title
Degree of stent embedding
Description
This relates to what degree, if at all, the stent strut is 'buried' within the coronary artery wall. The proportion of each strut that is buried or embedded will be calculated and then averaged for each stent group. A strut that is buried in the vessel wall for more than half its thickness will be defined as 'embedded'.
Time Frame
Immediate post stent deployment during the same angiographic procedure within 60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of a coronary artery stenosis undergoing percutaneous coronary intervention and stenting (PCI).
Eligibility for drug eluting stent (DES) deployment.
Stable or unstable coronary syndrome presentation, including ST elevation myocardial infarction (STEMI).
Aged 18-90
Exclusion Criteria:
Contraindication to the use of a DES.
Target lesion located within previous stent (in stent restenosis).
Sustained haemodynamic instability following stent deployment (Systolic BP 90≤ mmHg or sustained ventricular arrhythmia).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miles CD Dalby, MD, MRCP
Organizational Affiliation
Consultant Cardiologist, The Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert D Smith, MD, MRCP
Organizational Affiliation
The Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Study Director
Facility Information:
Facility Name
Harefield Hospital
City
Harefield
State/Province
Middlesex
ZIP/Postal Code
UB96JH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study to Examine the Implantation Characteristics of Two Drug-Eluting Stents
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