Distal embolisation during percutaneous coronary intervention - evaluation of contributory factors and analysis of embolic material

ISRCTN	ISRCTN86339277
DOI	https://doi.org/10.1186/ISRCTN86339277
Protocol serial number	N0176115666
Sponsor	Department of Health (UK)
Funder	Oxford Radcliffe Hospitals NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Daniel Blackman
Scientific

Department of Cardiology
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Phone	+44 (0)1865 741166
Email	Cardiology.registrars@orh.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The aim of this study is to assess distal embolisation during high-risk PCI, and to evaluate the factors which determine the degree of distal embolisation, measured according to the amount of material trapped in the collection filter. In particular we aim to determine whether the use of different types of stent influences the degree of distal embolisation. The secondary aim of this study is to perform analysis of material collected in the filter bag during PCI to provide insight into its make-up, and to compare its make-up in different patient groups.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cardiovascular: Distal embolisation
Intervention	Use of Symbiot self-expanding stent or a conventional stent.
Intervention type	Other
Primary outcome measure(s)	Primary endpoint: amount of distal embolisation determined by weight of material collected in distal protection device.
Key secondary outcome measure(s)	Secondary endpoints: 1. Troponin I at 12 h 2. Analysis of debris collected within distal protection device
Completion date	01/07/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	100
Key inclusion criteria	1. Patients undergoing PCI (percutaneous coronary intervention) to saphenous vein grafts. 2. Patients undergoing PCI for an acute coronary syndrome. ≥15 mm length of vessel beyond lesion and before graft insertion or major side-branch of native vessel to allow placement of filter wire.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/07/2002
Date of final enrolment	01/07/2003

Department of Cardiology

Oxford
OX3 9DU
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2005		Yes	No