Xience or Vision Stent Management of Angina in the Elderly

Coronary Artery Disease Clinical Trial

— XIMA  

Official title:

Multi-centre, Randomised,Prospective Trial of Xience or Vision Stent, Management of Angina in the Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198716
• Other study ID #: Version 2.0 20.06.2008
• Status: Completed
• Phase: N/A
• First received: July 16, 2014
• Last updated: August 13, 2014
• Start date: November 2008
• Est. completion date: August 2012

Study information

• Verified date: August 2014
• Source: Brighton and Sussex University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Percutaneous Coronary Intervention using drug eluting stents
Percutaneous Coronary Intervention using drug eluting stents
• Percutaneous Coronary Intervention using bare metal stents
Percutaneous Coronary Intervention using bare metal stents

Locations

Country	Name	City	State
United Kingdom	Cardiac Research Unit	Brighton	Sussex

Sponsors (2)

Lead Sponsor	Collaborator
Brighton and Sussex University Hospitals NHS Trust	Abbott Vascular

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year	No
Secondary	Angina status	This will be assessed in two ways: i) by interview according to the Canadian Cardiovascular Society classification; ii) by patient self-assessment using the Seattle questionnaire	1 year	No
Secondary	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	1 year	No
Secondary	Procedural success	Defined as TIMI 3 flow and <30% stenosis in the main vessel and TIMI 3 flow in the side branch	1 Year	No
Secondary	MACE (major adverse cardiovascular events)	Defined as death, myocardial infarction, or emergency (within 24 hours) coronary artery bypass grafting.	1 year	No
Secondary	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	1 Year	No
Secondary	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.	1 Year	No