Distal embolisation during percutaneous coronary intervention - evaluation of contributory factors and analysis of embolic material
| ISRCTN | ISRCTN86339277 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86339277 |
| Secondary identifying numbers | N0176115666 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 12/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Daniel Blackman
Scientific
Scientific
Department of Cardiology
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 741166 |
|---|---|
| Cardiology.registrars@orh.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 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 study start date | 01/07/2002 |
| Completion date | 01/07/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 100 patients |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Cardiology
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Oxford Radcliffe Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2005 | Yes | No |
