Xience® or Vision® stent - Management of Angina in the elderly

ISRCTN	ISRCTN92243650
DOI	https://doi.org/10.1186/ISRCTN92243650
Protocol serial number	version 2.0
Sponsor	Brighton and Sussex University Hospitals NHS Trust (UK)
Funder	Abbott Laboratories Limited (UK)

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

The Sussex Cardiac Centre
Royal Sussex County Hospital
Brighton
BN2 5BE
United Kingdom

Phone	+44 (0)1273 696955 x 4897
Email	adam.debelder@bsuh.nhs.uk

Study information

Primary study design	Interventional
Study design	Multicentre randomised prospective controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(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
Key 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.
Completion date	01/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England
Spain

Study participating centre

The Sussex Cardiac Centre

Brighton
BN2 5BE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes