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Xience or Vision Stent Management of Angina in the Elderly (XIMA)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention using drug eluting stents
Percutaneous Coronary Intervention using bare metal stents
Sponsored by
Brighton and Sussex University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Percutaneous coronary intervention, Elderly, Angina

Eligibility Criteria

80 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiac Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Drug eluting stent

Bare Metal Stent

Arm Description

Percutaneous coronary intervention

Percutaneous Coronary Intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Procedural success
Defined as TIMI 3 flow and <30% stenosis in the main vessel and TIMI 3 flow in the side branch
MACE (major adverse cardiovascular events)
Defined as death, myocardial infarction, or emergency (within 24 hours) coronary artery bypass grafting.
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
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.

Full Information

First Posted
July 16, 2014
Last Updated
August 13, 2014
Sponsor
Brighton and Sussex University Hospitals NHS Trust
Collaborators
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02198716
Brief Title
Xience or Vision Stent Management of Angina in the Elderly
Acronym
XIMA
Official Title
Multi-centre, Randomised,Prospective Trial of Xience or Vision Stent, Management of Angina in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brighton and Sussex University Hospitals NHS Trust
Collaborators
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Percutaneous coronary intervention, Elderly, Angina

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug eluting stent
Arm Type
Other
Arm Description
Percutaneous coronary intervention
Arm Title
Bare Metal Stent
Arm Type
Other
Arm Description
Percutaneous Coronary Intervention
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention using drug eluting stents
Other Intervention Name(s)
Xience Drug eluting stent
Intervention Description
Percutaneous Coronary Intervention using drug eluting stents
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention using bare metal stents
Other Intervention Name(s)
Vision BM stent
Intervention Description
Percutaneous Coronary Intervention using bare metal stents
Primary Outcome Measure Information:
Title
Death/ Myocardial Infarction/Target Vessel Failure/Major Haemorrhage
Description
This is a composite outcome measure consisting of multiple measures of the events of Death, Myocardial Infarction,Target Vessel Failure, and/or Major Haemorrhage
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Angina status
Description
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
Time Frame
1 year
Title
Antianginal medication
Description
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
Time Frame
1 year
Title
Procedural success
Description
Defined as TIMI 3 flow and <30% stenosis in the main vessel and TIMI 3 flow in the side branch
Time Frame
1 Year
Title
MACE (major adverse cardiovascular events)
Description
Defined as death, myocardial infarction, or emergency (within 24 hours) coronary artery bypass grafting.
Time Frame
1 year
Title
In-hospital complications
Description
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
Time Frame
1 Year
Title
Procedural cost
Description
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.
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cardiac Research Unit
City
Brighton
State/Province
Sussex
ZIP/Postal Code
BN2 1ES
Country
United Kingdom

12. IPD Sharing Statement

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Xience or Vision Stent Management of Angina in the Elderly

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