Coronary Artery DiseaseORCA-2NCT01201369
A Study to Examine the Implantation Characteristics of Two Drug-Eluting Stents
A study testing Coronary Stent Cypher and Coronary stent Xience in people with Coronary Artery Disease, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary Stent Cypher and Coronary stent Xience
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Rates of Strut Malapposition Between Everolimus and Sirolimus Eluting Stents - A Randomised Optical Coherence Tomography Study
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary Stent Cypher, Coronary stent Xience
- Keywords
- Percutaneous Coronary Intervention, Coronary Artery Stenosis, Acute Myocardial Infarction, Coronary Artery Stent, Optical Coherence Tomography
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Stent CypherDevice
The angioplasty will then be performed in a usual fashion in accordance with the operator's discretion and local protocols.
Coronary stent XienceDevice
The angioplasty will then be performed in a usual fashion in accordance with the operator's discretion and local protocols
| Study group | Role | What they receive |
|---|---|---|
| Cypher™ Stent | Active comparator | Participants in the Cypher arm will be randomised to receive a Cypher™ (Cordis, Miami Lake, USA) coronary stent Receives: Device: Coronary Stent Cypher |
| Xience™ Stent | Active comparator | Patients in the Xience™ arm will receive a Xience™ Stent(Abbott Vascular, Santa Clara, USA. Receives: Device: Coronary stent Xience |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediate post stent deployment during the same angiographic procedure within 60 minutes
Secondary outcomes (2)
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.
Measured: Immediate post stent deployment during the same angiographic procedure within 60 minutes
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'.
Measured: Immediate post stent deployment during the same angiographic procedure within 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Miles CD Dalby, MD, MRCP, Principal investigator, Consultant Cardiologist, The Royal Brompton & Harefield NHS Foundation TrustRobert D Smith, MD, MRCP, Study director, The Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201369
- Sponsor's protocol ID
- ORCA-2
- Acronym
- ORCA-2
- Status last verified
- Jul 2011
- First submitted
- 24 Aug 2010
- Last updated
- 12 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rates of Strut Malapposition Between Everolimus and Sirolimus Eluting Stents - A Randomised Optical Coherence Tomography Study
- ClinicalTrials.gov ID
- NCT01201369
- Acronym / sponsor ID
- ORCA-2 / ORCA-2
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous Coronary Intervention, Coronary Artery Stenosis, Acute Myocardial Infarction, Coronary Artery Stent, Optical Coherence Tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 14 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cypher™ Stent | Active comparator | Device: Coronary Stent CypherParticipants in the Cypher arm will be randomised to receive a Cypher™ (Cordis, Miami Lake, USA) coronary stent |
| Xience™ Stent | Active comparator | Device: Coronary stent XiencePatients in the Xience™ arm will receive a Xience™ Stent(Abbott Vascular, Santa Clara, USA. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Stent CypherThe angioplasty will then be performed in a usual fashion in accordance with the operator's discretion and local protocols. | Device | Cypher™ Stent |
| Coronary stent XienceThe angioplasty will then be performed in a usual fashion in accordance with the operator's discretion and local protocols | Device | Xience™ Stent |
Primary outcome
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.
2 secondary outcomes
Stent eccentricity index (SEI)
Time frame: Immediate post stent deployment during the same angiographic procedure within 60 minutes
Degree of stent embedding
Time frame: Immediate post stent deployment during the same angiographic procedure within 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miles CD Dalby, MD, MRCP principal investigator
Consultant Cardiologist, The Royal Brompton & Harefield NHS Foundation Trust
Robert D Smith, MD, MRCP study director
The Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Stent Cypher and Coronary stent Xience in people with Coronary Artery Disease, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent strut malapposition (SSM) (time frame: Immediate post stent deployment during the same angiographic procedure within 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2011.