Carotid Artery ThrombosisNCT02341196
Randomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy
A study testing CEA in people with Carotid Artery Thrombosis and Carotid Artery Stenosis, run by University of Poitiers.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 90 years
- Conditions the study is for
- Carotid Artery Thrombosis, Carotid Artery Stenosis, Stroke
- What is being tested?
- CEA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Jan 1995to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Carotid stenosis > 60% NASCET criteria
Who cannot join
- 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
About this study
Official title: Randomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy. Long-term Results
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)
Read the detailed description
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.
598 patients were considered for randomisation between January 1995 and January 2004. The following patients were excluded for randomisation (Redo carotid surgery: N=34, radiation induced carotid stenosis:N=45, indication for carotid bypass: N=65, Refusal of randomisation: N=4).
In total, 450 patients were randomized in two groups, 225 received a polyester patch and 225 received a polyurethane patch.
All patients were operated under general anaesthesia and all received an intraoperative angiography. A shunt was selectively used in patients with a recent stroke (<15 days) or with a contralateral carotid occlusion
- Conditions
- Carotid Artery Thrombosis, Carotid Artery Stenosis, Stroke
- Being tested
- CEA
- Medical subject headings
- Carotid Artery Thrombosis, Carotid Stenosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEAProcedure or surgery
Also called Carotid endarterectomy
Patients in both groups received an intra-operative angiography
| Study group | Role | What they receive |
|---|---|---|
| CEA + Polyester patch | Experimental | 225 Patients Receives: Procedure: CEA |
| CEA + Patch Polyurethane | Experimental | 225 Patients Receives: Procedure: CEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
carotid artery restenosis
Restenosis of carotid endarterectomy > 70% in diameter occurring 5 to 10 years after surgery diagnosed by color duplex ultrasound
Measured: 5 to 10 years after surgery
Secondary outcomes (2)
Any death occurring during follow-up
All death even those not related to carotid surgery
Measured: Time 0 (operation) to 10 years after surgery
Any ipsilateral stroke
Any paralysis occurring in relation with the operated carotid artery and lasting more than 24 hours
Measured: 0 days to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startJan 1995
- Primary completionJan 2004
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Poitiers
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza
- Responsible party
- Sponsor
- Investigators
- Giulio Illuminati, MD, PhD, Study chair, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341196
- Sponsor's protocol ID
- JBR01
- Status last verified
- Jan 2015
- First submitted
- 21 Dec 2014
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy. Long-term Results
- ClinicalTrials.gov ID
- NCT02341196
- Acronym / sponsor ID
- JBR01
- Conditions
- Carotid Artery Thrombosis, Carotid Artery Stenosis, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- University of PoitiersUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza
- Study start
- Jan 1995
- Primary completion
- Jan 2004 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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.
598 patients were considered for randomisation between January 1995 and January 2004. The following patients were excluded for randomisation (Redo carotid surgery: N=34, radiation induced carotid stenosis:N=45, indication for carotid bypass: N=65, Refusal of randomisation: N=4).
In total, 450 patients were randomized in two groups, 225 received a polyester patch and 225 received a polyurethane patch.
All patients were operated under general anaesthesia and all received an intraoperative angiography. A shunt was selectively used in patients with a recent stroke (<15 days) or with a contralateral carotid occlusion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEA + Polyester patch | Experimental | Procedure: CEA225 Patients |
| CEA + Patch Polyurethane | Experimental | Procedure: CEA225 Patients |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Carotid stenosis > 60% NASCET criteria
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CEAAlso: Carotid endarterectomyPatients in both groups received an intra-operative angiography | Procedure or surgery | CEA + Patch Polyurethane, CEA + Polyester patch |
Primary outcome
carotid artery restenosis
Time frame: 5 to 10 years after surgery
Restenosis of carotid endarterectomy > 70% in diameter occurring 5 to 10 years after surgery diagnosed by color duplex ultrasound
2 secondary outcomes
Any death occurring during follow-up
Time frame: Time 0 (operation) to 10 years after surgery
Any ipsilateral stroke
Time frame: 0 days to 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giulio Illuminati, MD, PhD study chair
University of Roma La Sapienza
Questions about this trial
What is this clinical trial studying?
A study testing CEA in people with Carotid Artery Thrombosis and Carotid Artery Stenosis, run by University of Poitiers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
carotid artery restenosis (time frame: 5 to 10 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2015.