A Study to Examine the Implantation Characteristics of Two Drug-Eluting Stents (ORCA-2)
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|ClinicalTrials.gov Identifier: NCT01201369|
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : July 12, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: Coronary Stent Cypher Device: Coronary stent Xience||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Rates of Strut Malapposition Between Everolimus and Sirolimus Eluting Stents - A Randomised Optical Coherence Tomography Study|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
Active Comparator: Cypher™ Stent
Participants in the Cypher arm will be randomised to receive a Cypher™ (Cordis, Miami Lake, USA) coronary stent
Device: Coronary Stent Cypher
The angioplasty will then be performed in a usual fashion in accordance with the operator's discretion and local protocols.
Active Comparator: Xience™ Stent
Patients in the Xience™ arm will receive a Xience™ Stent(Abbott Vascular, Santa Clara, USA.
Device: Coronary stent Xience
The angioplasty will then be performed in a usual fashion in accordance with the operator's discretion and local protocols
- Stent strut malapposition (SSM) [ Time Frame: Immediate post stent deployment during the same angiographic procedure within 60 minutes ]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.
- Stent eccentricity index (SEI) [ Time Frame: Immediate post stent deployment during the same angiographic procedure within 60 minutes ]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 [ Time Frame: Immediate post stent deployment during the same angiographic procedure within 60 minutes ]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'.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201369
|Harefield, Middlesex, United Kingdom, UB96JH|
|Principal Investigator:||Miles CD Dalby, MD, MRCP||Consultant Cardiologist, The Royal Brompton & Harefield NHS Foundation Trust|
|Study Director:||Robert D Smith, MD, MRCP||The Royal Brompton & Harefield NHS Foundation Trust|