|
Welcome
|
|
11 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Xience® or Vision® stent - Management of Angina in the elderly |
| ISRCTN | ISRCTN92243650 |
| ClinicalTrials.gov identifier | |
| Public title | Xience® or Vision® stent - Management of Angina in the elderly |
| 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 |
| Acronym | XIMA |
| Serial number at source | version 2.0 |
| Study hypothesis | 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. |
| Lay summary | |
| Ethics approval | King's college hospital research ethics committee approved on the 27th August 2008 ((ref: 08/H0808/107) |
| Study design | Multicentre randomised prospective controlled trial |
| Countries of recruitment | Spain, United Kingdom |
| Disease/condition/study domain | Coronary disease; acute coronary syndromes |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/10/2008 |
| Anticipated end date | 01/10/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use contact details to request a patient information sheet |
| Target number of participants | 800 |
| Interventions | 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. |
| Primary outcome measure(s) |
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 measure(s) |
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. |
| Sources of funding | Abbott Laboratories Limited (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Adam de Belder |
| Address |
The Sussex Cardiac Centre
Royal Sussex County Hospital |
| City/town | Brighton |
| Zip/Postcode | BN2 5BE |
| Country | United Kingdom |
| Tel | +44 (0)1273 696955 x 4897 |
| adam.debelder@bsuh.nhs.uk | |
| Sponsor | Brighton and Sussex University Hospitals NHS Trust (UK) |
| Address |
Royal Sussex County Hospital
Eastern Road |
| City/town | Brighton |
| Zip/Postcode | BN2 5BE |
| Country | United Kingdom |
| Tel | +44 (0)1273 696955 |
| scot.harfield@bsuh.nhs.uk | |
| Sponsor website: | http://www.bsuh.nhs.uk/home/ |
| Date applied | 24/02/2010 |
| Last edited | 17/03/2010 |
| Date ISRCTN assigned | 17/03/2010 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|