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Completed

NCT Number: NCT02198716

Xience or Vision Stent Management of Angina in the Elderly

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.

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Key information

Conditions

Coronary Artery Disease Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

80 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiac Research Unit

Brighton, Sussex, BN2 1ES, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous Coronary Intervention using drug eluting stents

Procedure

Percutaneous Coronary Intervention using drug eluting stents

Other names: Xience Drug eluting stent

Percutaneous Coronary Intervention using bare metal stents

Procedure

Percutaneous Coronary Intervention using bare metal stents

Other names: Vision BM stent

Primary outcomes

  1. Death/ Myocardial Infarction/Target Vessel Failure/Major Haemorrhage

    Time frame: 1 year

    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 outcomes

  1. Angina status

    Time frame: 1 year

    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

  2. Antianginal medication

    Time frame: 1 year

    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

  3. Procedural success

    Time frame: 1 Year

    Defined as TIMI 3 flow and <30% stenosis in the main vessel and TIMI 3 flow in the side branch

  4. MACE (major adverse cardiovascular events)

    Time frame: 1 year

    Defined as death, myocardial infarction, or emergency (within 24 hours) coronary artery bypass grafting.

  5. In-hospital complications

    Time frame: 1 Year

    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

  6. Procedural cost

    Time frame: 1 Year

    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.

Sponsors and collaborators

Lead sponsor

Brighton and Sussex University Hospitals NHS Trust

Other

Collaborators

  • Abbott Medical Devices

Registry information

Official study title

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

Acronym: XIMA

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 24, 2014
Registry last updated
Aug 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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