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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug eluting stent | Other | Percutaneous coronary intervention |
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| Bare Metal Stent | Other | Percutaneous Coronary Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Coronary Intervention using drug eluting stents | Procedure | Percutaneous Coronary Intervention using drug eluting stents |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Antianginal medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac Research Unit | Brighton | Sussex | BN2 1ES | United Kingdom |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Percutaneous Coronary Intervention using bare metal stents | Procedure | Percutaneous Coronary Intervention using bare metal stents |
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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 |
| Procedural success | Defined as TIMI 3 flow and <30% stenosis in the main vessel and TIMI 3 flow in the side branch | 1 Year |
| MACE (major adverse cardiovascular events) | Defined as death, myocardial infarction, or emergency (within 24 hours) coronary artery bypass grafting. | 1 year |
| 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 |
| 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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |