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The sub-optimal angioplasty result trial

Objective

OBJECTIVES
%ù To establish whether stent placement or no treatment is associated with improved 12 month clinical outcome and wellbeing after a sub-optimal (not poor) coronary balloon angioplasty result.
ù To establish the Health Care costs of each of these strategies.
ù To create a collaborative European network in the field of research in Interventional Cardiology.
ù To integrate national and European funding and obtain maximum value from both.

BRIEF DESCRIPTION
Trial design:Clinical, multicentre, randomised, open, controlled trial
Setting:11 hospitals performing percutaneous transluminal coronaryangioplasty (PTCA)
Participants: Interventional cardiologists
Co-ordinator: Professor David Cumberland, Sheffield, UK
European partners: Rouen, Orebo, Hamburg, Zwolle, Nieuwegen, Thessaloniki, Sheffield, Edinburgh, Leeds, Liverpool, Newcastle
Industrial collaborator: Biocompatibles Limited (stent manufacturer)
Patients: 912
Entry criterion: A sub-optimal result (carefully defined) after single vessel PTCA
Starting date: 1998
Follow-up: 12 months per patient
Duration of trial: 3 years
Sub-group analysis: Single centre angiographic follow-up sub-group
Trial arms: No further treatment (control group) or stent placement
Analysis: Intention-to-treat
End points: MACE (Major adverse cardiac events)
Outcomes: Improved clinical outcomes
Better informed clinical decision making
Potential for economising on stent expenditureEuropean added value: Pan-European approach vital for recruitment
Major deliverable: Publication of Study results

KEYWORDS
Coronary angioplasty, randomised controlled trial, sub-optimal result, stent

Funding Scheme

CON - Coordination of research actions

Coordinator

University of Sheffield
Address
2-4,Palmerston Road 2-4
S10 2TE Sheffield
United Kingdom