Randomized Clinical Trial of Polyester vs. Polyurethane P... | NCT02341196

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

NCT02341196

Sponsor

University of Poitiers

Status

Completed

Last Update Posted

Jan 19, 2015Estimated

Enrollment

450Actual

Phase

Not Applicable

Conditions

Carotid Artery Thrombosis
Carotid Artery Stenosis
Stroke

Interventions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1995

Primary Completion Date

Jan 2004Actual

Completion Date

Dec 2014Actual

First Submitted Date

Dec 21, 2014

First Submission Date that Met QC Criteria

Jan 13, 2015

First Posted Date

Jan 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2015

Last Update Posted Date

Jan 19, 2015Estimated

Name	Class
University of Roma La Sapienza	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

450Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CEA + Polyester patch	Experimental	225 Patients	Procedure: CEA
CEA + Patch Polyurethane	Experimental	225 Patients	Procedure: CEA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CEA	Procedure	Patients in both groups received an intra-operative angiography	CEA + Patch Polyurethane CEA + Polyester patch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Any death occurring during follow-up	All death even those not related to carotid surgery	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giulio Illuminati, MD, PhD	University of Roma La Sapienza	Study Chair

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002341	Carotid Artery Thrombosis
D016893	Carotid Stenosis
D020521	Stroke

Ancestor Terms

ID	Term
D002340	Carotid Artery Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016894	Endarterectomy, Carotid

Ancestor Terms

ID	Term
D004691	Endarterectomy
D014656	Vascular Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided