Coronary Artery DiseaseXIMANCT02198716
Xience or Vision Stent Management of Angina in the Elderly
A study testing Percutaneous Coronary Intervention using drug eluting stents and Percutaneous Coronary Intervention using bare metal stents in people with Coronary Artery Disease, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The treatment of complex coronary disease causing limiting symptoms of angina with drug-eluting stent technology will prove superior to bare metal stent technology, with respect to a combined endpoint of mortality, MI, requirement for target vessel revascularisation and severe haemorrhage, in patients aged 80 or above. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous Coronary Intervention using drug eluting stents and Percutaneous Coronary Intervention using bare metal stents
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2008to Aug 2012
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- AGE>80
- Stable angina or acute coronary syndrome
- Coronary narrowing suitable for stenting that is either ≥15mm long and/or ≤3mm diameter.
- Any lesion with high risk of restenosis eg chronic total occlusion, bifurcation, severe calcification
- Any left main stem lesion
Who cannot join
- Acute ST segment elevation myocardial infarction
- Cardiogenic shock
- Platelet count =50 x 109/mm3
- Patient life expectancy < 1 year
- Known allergies to clopidogrel, aspirin, heparin, stainless steel, IV contrast or stent drug elutant
- Recent major GI haemorrhage (within 3 months)
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- Any previous cerebral bleeding episode
- Participation in another investigational drug or device study
- Patient unable to give consent
- Clinical decision precluding the use of drug eluting stent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-centre, Randomised,Prospective Trial of Xience or Vision Stent, Management of Angina in the Elderly
The treatment of complex coronary disease causing limiting symptoms of angina with drug-eluting stent technology will prove superior to bare metal stent technology, with respect to a combined endpoint of mortality, MI, requirement for target vessel revascularisation and severe haemorrhage, in patients aged 80 or above.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous Coronary Intervention using drug eluting stents, Percutaneous Coronary Intervention using bare metal stents
- Keywords
- Percutaneous coronary intervention, Elderly, Angina
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary Intervention using drug eluting stentsProcedure or surgery
Also called Xience Drug eluting stent
Percutaneous Coronary Intervention using drug eluting stents
Percutaneous Coronary Intervention using bare metal stentsProcedure or surgery
Also called Vision BM stent
Percutaneous Coronary Intervention using bare metal stents
| Study group | Role | What they receive |
|---|---|---|
| Drug eluting stent | Other | Percutaneous coronary intervention Receives: Procedure: Percutaneous Coronary Intervention using drug eluting stents |
| Bare Metal Stent | Other | Percutaneous Coronary Intervention Receives: Procedure: Percutaneous Coronary Intervention using bare metal stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death/ Myocardial Infarction/Target Vessel Failure/Major Haemorrhage
This is a composite outcome measure consisting of multiple measures of the events of Death, Myocardial Infarction,Target Vessel Failure, and/or Major Haemorrhage
Measured: 1 year
Secondary outcomes (6)
Angina status
This will be assessed in two ways:
- by interview according to the Canadian Cardiovascular Society classification ii) by patient self-assessment using the Seattle questionnaire
Measured: 1 year
Antianginal medication
This will be assessed using a single point scoring system, where a point is scored for each of the following:
Nitrate (sublingual or spray) used 1 or mnore times during week prior to question Nitrate (oral) beta-blocker Calcium antagonist Use of Nicorandil
Measured: 1 year
Procedural success
Defined as TIMI 3 flow and <30% stenosis in the main vessel and TIMI 3 flow in the side branch
Measured: 1 Year
MACE (major adverse cardiovascular events)
Defined as death, myocardial infarction, or emergency (within 24 hours) coronary artery bypass grafting.
Measured: 1 year
In-hospital complications
Major procedural complications include Death Myocardial infarction Emergency coronary artery bypass surgery Stroke Bleeding ('Thrombolysis In Myocardial Infarction)
Minor procedural complications include Ventricular rhythm disorder (tachy or brady) requiring intervention (e.g defibrillation, DC cardioversion or temporary pacing) Bleeding Pseudoaneurysm requiring compression or surgery Vascular access complication extending hospital stay by 1 or more night Transient ischaemic attack Wire loss or fracture Stent loss Undeployed stent detachment from balloon
Measured: 1 Year
Procedural cost
The difference in procedural cost will be assessed using a composite of the number of, guidewires, balloons and stents opened or used and procedural time. Prolonged hospital stay is a further potential cost pressure in this age group.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startNov 2008
- Primary completionAug 2012
- Study completionAug 2012
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
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brighton and Sussex University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Principal investigator, Adam de Belder, Brighton and Sussex University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198716
- Sponsor's protocol ID
- Version 2.0 20.06.2008
- Acronym
- XIMA
- Status last verified
- Aug 2014
- First submitted
- 16 Jul 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre, Randomised,Prospective Trial of Xience or Vision Stent, Management of Angina in the Elderly
- ClinicalTrials.gov ID
- NCT02198716
- Acronym / sponsor ID
- XIMA / Version 2.0 20.06.2008
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous coronary intervention, Elderly, Angina
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Brighton and Sussex University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Nov 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 24 Jul 2014 (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.
The treatment of complex coronary disease causing limiting symptoms of angina with drug-eluting stent technology will prove superior to bare metal stent technology, with respect to a combined endpoint of mortality, MI, requirement for target vessel revascularisation and severe haemorrhage, in patients aged 80 or above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug eluting stent | Other | Procedure: Percutaneous Coronary Intervention using drug eluting stentsPercutaneous coronary intervention |
| Bare Metal Stent | Other | Procedure: Percutaneous Coronary Intervention using bare metal stentsPercutaneous Coronary Intervention |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- AGE>80
- Stable angina or acute coronary syndrome
- Coronary narrowing suitable for stenting that is either ≥15mm long and/or ≤3mm diameter.
- Any lesion with high risk of restenosis eg chronic total occlusion, bifurcation, severe calcification
- Any left main stem lesion
Key exclusion criteria (10 listed)
- Acute ST segment elevation myocardial infarction
- Cardiogenic shock
- Platelet count =50 x 109/mm3
- Patient life expectancy < 1 year
- Known allergies to clopidogrel, aspirin, heparin, stainless steel, IV contrast or stent drug elutant
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 |
|---|---|---|
| Percutaneous Coronary Intervention using drug eluting stentsAlso: Xience Drug eluting stentPercutaneous Coronary Intervention using drug eluting stents | Procedure or surgery | Drug eluting stent |
| Percutaneous Coronary Intervention using bare metal stentsAlso: Vision BM stentPercutaneous Coronary Intervention using bare metal stents | Procedure or surgery | Bare Metal Stent |
Primary outcome
Death/ Myocardial Infarction/Target Vessel Failure/Major Haemorrhage
Time frame: 1 year
This is a composite outcome measure consisting of multiple measures of the events of Death, Myocardial Infarction,Target Vessel Failure, and/or Major Haemorrhage
6 secondary outcomes
Angina status
Time frame: 1 year
Antianginal medication
Time frame: 1 year
Procedural success
Time frame: 1 Year
MACE (major adverse cardiovascular events)
Time frame: 1 year
In-hospital complications
Time frame: 1 Year
Procedural cost
Time frame: 1 Year
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 15 Aug 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Coronary Intervention using drug eluting stents and Percutaneous Coronary Intervention using bare metal stents in people with Coronary Artery Disease, run by Brighton and Sussex University Hospitals NHS 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 5 inclusion and 10 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 15 Aug 2014. 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?
Death/ Myocardial Infarction/Target Vessel Failure/Major Haemorrhage (time frame: 1 year). 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 15 Aug 2014.