Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
12/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel Blackman

ORCID ID

Contact details

Department of Cardiology
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 741166
Cardiology.registrars@orh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0176115666

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Cardiovascular: Distal embolisation

Intervention

Use of Symbiot self-expanding stent or a conventional stent.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Primary endpoint: amount of distal embolisation determined by weight of material collected in distal protection device.

Secondary outcome measures

Secondary endpoints:
1. Troponin I at 12 h
2. Analysis of debris collected within distal protection device

Overall trial start date

01/07/2002

Overall trial end date

01/07/2003

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100 patients

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/07/2002

Recruitment end date

01/07/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Cardiology
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Oxford Radcliffe Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16264208

Publication citations

  1. Results

    Blackman DJ, Choudhury RP, Banning AP, Channon KM, Failure of the Symbiot PTFE-covered stent to reduce distal embolization during percutaneous coronary intervention in saphenous vein grafts., J Invasive Cardiol, 2005, 17, 11, 609-612.

Additional files

Editorial Notes