Xience® or Vision® stent - Management of Angina in the elderly
| ISRCTN | ISRCTN92243650 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92243650 |
| Secondary identifying numbers | version 2.0 |
- Submission date
- 24/02/2010
- Registration date
- 17/03/2010
- Last edited
- 13/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Adam de Belder
Scientific
Scientific
The Sussex Cardiac Centre
Royal Sussex County Hospital
Brighton
BN2 5BE
United Kingdom
| Phone | +44 (0)1273 696955 x 4897 |
|---|---|
| adam.debelder@bsuh.nhs.uk |
Study information
| Study design | Multicentre randomised prospective controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | A multicentre randomised controlled trial of drug-eluting versus bare metal stents in the treatment of patients over 80 years of age with complex coronary artery disease |
| Study acronym | XIMA |
| Study objectives | The treatment of complex coronary disease causing limiting symptoms of angina with drug-eluting stent (DES) technology will prove superior to bare metal stent (BMS) technology, with respect to a combined endpoint of mortality, myocardial infarction (MI), requirement for target vessel revascularisation and severe haemorrhage, in patients aged 80 or above. |
| Ethics approval(s) | King's college hospital research ethics committee approved on the 27th August 2008 ((ref: 08/H0808/107) |
| Health condition(s) or problem(s) studied | Coronary disease; acute coronary syndromes |
| Intervention | The treatment is a procedure percutaneous coronary intervention. Patients are randomised to receive either a Drug eluting stent or a Bare metal stent. Both arms are followed up for 1 year. |
| Intervention type | Other |
| Primary outcome measure | Combined primary outcome at 1 year 1.1. Death 1.2. Myocardial infarction 1.3. Target Vessel Failure 1.4. Major haemorrhage 2. Procedural cost |
| Secondary outcome measures | 1. Angina status 2. Antianginal tablet prescription (Rx) 3. Procedural 3.1. Procedure success 3.2. Procedure Major Adverse Cardiac Events (MACE) 3.3. In-hospital complications All secondary outcomes will be measured at 3, 6, 12 months. |
| Overall study start date | 01/10/2008 |
| Completion date | 01/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 800 |
| Key inclusion criteria | 1. Age > 80 years 2. Stable angina or acute coronary syndrome 3. Coronary narrowing suitable for stenting that is either =15mm long and/or =3mm diameter. 4. Any lesion with high risk of restenosis eg chronic total occlusion (CTO), bifurcation, severe calcification 5. Any left main stem lesion |
| Key exclusion criteria | 1. Acute ST-Segment Elevation Myocardial Infarction (STEMI) 2. Cardiogenic shock 3. Platelet count =50 x 109/mm^3 4. Patient life expectancy < 1 year 5. Known allergies to clopidogrel, aspirin, heparin, stainless steel, IV contrast or stent drug elutant 6. Recent major gastrointestinal (GI) haemorrhage (within 3 months) 7. Any previous cerebral bleeding episode 8. Participation in another investigational drug or device study 9. Patient unable to give consent 10. Clinical decision precluding the use of DES |
| Date of first enrolment | 01/10/2008 |
| Date of final enrolment | 01/10/2011 |
Locations
Countries of recruitment
- England
- Spain
- United Kingdom
Study participating centre
The Sussex Cardiac Centre
Brighton
BN2 5BE
United Kingdom
BN2 5BE
United Kingdom
Sponsor information
Brighton and Sussex University Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
England
United Kingdom
| Phone | +44 (0)1273 696955 |
|---|---|
| scot.harfield@bsuh.nhs.uk | |
| Website | http://www.bsuh.nhs.uk/home/ |
Funders
Funder type
Industry
Abbott Laboratories Limited (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/04/2014 | Yes | No |
