Randomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy

Stroke Clinical Trial

Official title:

Randomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy. Long-term Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02341196
• Other study ID #: JBR01
• Status: Completed
• Phase: N/A
• First received: December 21, 2014
• Last updated: January 13, 2015
• Start date: January 1995
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: University of Poitiers
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical 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.

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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: December 2014
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 90 Years

Eligibility

Inclusion Criteria:

• Carotid stenosis > 60% NASCET criteria

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Artery Thrombosis
• Carotid Stenosis
• Stroke

Intervention

Procedure:
• CEA
Patients in both groups received an intra-operative angiography

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Poitiers	University of Roma La Sapienza

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Any death occurring during follow-up	All death even those not related to carotid surgery	Time 0 (operation) to 10 years after surgery	No
Secondary	Any ipsilateral stroke	Any paralysis occurring in relation with the operated carotid artery and lasting more than 24 hours	0 days to 10 years	No