NCT02681341

Brief Summary

The primary objective of this study is to confirm that properties of CardioCel provide operative benefit to surgeons when compared to Dacron, CorMatrix, and all other bovine pericardium not treated with proprietary ADAPT engineering.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

January 22, 2016

Last Update Submit

October 24, 2017

Conditions

Carotid Endarterectomy

Outcome Measures

Primary Outcomes (1)

  • 6 Month Duplex US Report to Measure Material Quality

    The 6 month duplex US report will measure peak velocity and flow through the repaired carotid artery, caliber, and occlusion/lesion status as per normal parameters used in post-CEA scans.

    Up to 6 months post CEA

Secondary Outcomes (1)

  • OR Data and Surgeon Feedback During the Procedure

    procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients needing a carotid endarterectomy with patch arterioplasty

You may qualify if:

  • Scheduled for carotid endarterectomy (CEA) with patch arterioplasty
  • Expected lifespan of over 24 months
  • Age over 18 years

You may not qualify if:

  • Revision of previous CEA arterioplasty
  • Active infection
  • Cerebral ischemic event (completed stroke) within 30 days of planned surgery
  • Pregnant or breastfeeding
  • Concomitant surgical or endovascular procedure being performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Study Officials

  • Dennis Gable, MD

    Baylor Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2016

First Posted

February 12, 2016

Study Start

February 1, 2016

Primary Completion

April 24, 2017

Study Completion

September 21, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)