Randomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy
1 other identifier
interventional
450
0 countries
N/A
Brief Summary
This study examines the risk of thrombogenicity of the carotid patches in polyurethane compared to carotid patches in polyester including death, any stroke, carotid thrombosis at 30 days and long-term results including stroke and recurrent carotid stenosis at 10 years. This study was run at the University of Roma, La Sapienza and at the University of Poitiers, randomisation was done in both enters after approval by the Ethical committee of the University of Roma (Record uploaded)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 1995
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1995
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 21, 2014
CompletedFirst Posted
Study publicly available on registry
January 19, 2015
CompletedJanuary 19, 2015
January 1, 2015
9 years
December 21, 2014
January 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
carotid artery restenosis
Restenosis of carotid endarterectomy \> 70% in diameter occurring 5 to 10 years after surgery diagnosed by color duplex ultrasound
5 to 10 years after surgery
Secondary Outcomes (2)
Any death occurring during follow-up
Time 0 (operation) to 10 years after surgery
Any ipsilateral stroke
0 days to 10 years
Study Arms (2)
CEA + Polyester patch
EXPERIMENTAL225 Patients
CEA + Patch Polyurethane
EXPERIMENTAL225 Patients
Interventions
Patients in both groups received an intra-operative angiography
Eligibility Criteria
You may qualify if:
- Carotid stenosis \> 60% NASCET criteria
You may not qualify if:
- Redo carotid surgery
- Radiation induced carotid stenosis
- Extensive carotid lesion \> 5 cm in length with involvement of the common carotid artery best treated by a carotid bypass
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Poitierslead
- University of Roma La Sapienzacollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Giulio Illuminati, MD, PhD
University of Roma La Sapienza
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2014
First Posted
January 19, 2015
Study Start
January 1, 1995
Primary Completion
January 1, 2004
Study Completion
December 1, 2014
Last Updated
January 19, 2015
Record last verified: 2015-01