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

This study has been completed.
Sponsor:
Collaborator:
Abbott Vascular
Information provided by (Responsible Party):
Adam de Belder, Brighton and Sussex University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT02198716
First received: July 16, 2014
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Procedure: Percutaneous Coronary Intervention using drug eluting stents
Procedure: Percutaneous Coronary Intervention using bare metal stents

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-centre, Randomised,Prospective Trial of Xience or Vision Stent, Management of Angina in the Elderly

Resource links provided by NLM:


Further study details as provided by Brighton and Sussex University Hospitals NHS Trust:

Primary Outcome Measures:
  • Death/ Myocardial Infarction/Target Vessel Failure/Major Haemorrhage [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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 [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Defined as death, myocardial infarction, or emergency (within 24 hours) coronary artery bypass grafting.

  • In-hospital complications [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

    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 [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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.


Enrollment: 800
Study Start Date: November 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Drug eluting stent
Percutaneous coronary intervention
Procedure: Percutaneous Coronary Intervention using drug eluting stents
Percutaneous Coronary Intervention using drug eluting stents
Other Name: Xience Drug eluting stent
Bare Metal Stent
Percutaneous Coronary Intervention
Procedure: Percutaneous Coronary Intervention using bare metal stents
Percutaneous Coronary Intervention using bare metal stents
Other Name: Vision BM stent

  Eligibility

Ages Eligible for Study:   80 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02198716

Locations
United Kingdom
Cardiac Research Unit
Brighton, Sussex, United Kingdom, BN2 1ES
Sponsors and Collaborators
Brighton and Sussex University Hospitals NHS Trust
Abbott Vascular
  More Information

No publications provided

Responsible Party: Adam de Belder, Consultant Cardiologist, Brighton and Sussex University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02198716     History of Changes
Other Study ID Numbers: Version 2.0 20.06.2008
Study First Received: July 16, 2014
Last Updated: August 13, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Brighton and Sussex University Hospitals NHS Trust:
Percutaneous coronary intervention
Elderly
Angina

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014