Vascular Post Market Review

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.

Study Overview

• Status: Completed
• Conditions: Carotid Endarterectomy

Detailed Description

ENDPOINTS

1. OR experience: suturability, handling, hemostasis, compliance to recipient vessel, blood loss, OR time.
2. In-hospital survival
3. MAE (Stroke, MI, death)
4. 1 Month duplex US scan
5. 6 month duplex US scan

Secondary Efficacy Endpoints

1. Less than 50% stenosis at 6 months (PSV <150 cm/s)

Safety Endpoint

Incidence of CardioCel related Major Adverse Cardiac Events (MACE) at 6 months, defined for this study as:

• Structural CardioCel failure - aneurysm/dilation
• Vasculitis
• Leak or pseudoaneurysm
• Dehiscence
• Thromboembolism
• Thrombosis
• Haemolysis
• Reoperation and explant

Review endpoints at 6 months to confirm results meet the expectations of the Principal Investigator.

BACKGROUND

Rationale for Study:

CardioCel's unique strength, pliability, resistance to degradation and calcification make it a promising alternative to synthetic fabrics or other xenographic materials incompletely decellularized or detoxified (aldehyde removal).

Device Description:

Tissue-engineered CardioCel pericardium is manufactured from bovine spongiform encephalopathy-free pericardium (37). Manufacturing consists of several tissue-engineering processes, which include steps to remove lipids, cells and cell remnants, nucleic acids (DNA, RNA) and Gal epitopes. In addition, cross-linking is achieved with an ultra-low engineered glutaraldehyde concentration to minimise glutaraldehyde cytotoxicity levels (Admedus Ltd. proprietary). Cytotoxicity is further reduced by the ADAPT® anti-calcification process and a non-glutaraldehyde sterilisation and storage solution.

CardioCel is US FDA cleared for the repair of cardiac and vascular defects, including intra-cardiac defects; septal defects, valve and annulus repair, great vessel reconstruction, peripheral vascular reconstruction, suture line buttressing and pericardial closure.

STUDY DESIGN This is a prospective, non-randomized, single arm study.

SCHEDULE OF ASSESSMENTS/DATA COLLECTION

ENROLLMENT:

10 subjects to be enrolled per site

DURATION OF ENROLLMENT:

Patients will be followed for 6 months after CEA procedure.

SCREENING A pre-screening procedure may be performed to determine whether the patient meets the inclusion/exclusion eligibility selection criteria. A pre-screened patient will be asked to sign the informed consent form before any study-specific tests or procedures are performed. Subject screening numbers will be assigned at this visit and subjects will be evaluated for eligibility criteria.

BASELINE Informed consent will be obtained from all subjects who are potential trial candidates prior to commencement of any study related procedures.

The following baseline data will be collected for all subjects prior to procedure:

• Patient demographics
• Standard of care Physical Examination
• Vital Signs (Blood pressure and heart rate only)
• Medical history (for cardiovascular risk factors)
• Standard of care Clinical Lab tests
• Final confirmation of Inclusion/Exclusion Criteria

IMPLANT PROCEDURE Patients will undergo a CEA with patch arterioplasty. Patients will be managed according to standard pre-operative, operative, and postoperative care.

The following OR Experience data will be collected for all subjects:

• Suturability
• Handling
• Hemostasis
• Compliance to recipient vessel
• Blood loss
• OR time
• In-hospital survival
• MAE (Stroke, MI, death)

FOLLOW-UP VISITS Patients will return for follow-up visits that will include a carotid duplex ultrasound at 1 and 6 months. Follow-up visits may also include a physical examination and adverse event review.

The following follow-up data will be collected for all subjects:

• Standard of care physical examination
• 1 Month duplex US scan- Duplex US scanning for velocity, calibre, occlusion/lesion status
• 6 month duplex US scan- Duplex US scanning for velocity, calibre, occlusion/lesion status
• MAE (Stroke, MI, death) and AE review at each visit

STATISTICAL ANALYSIS & DATA MANAGEMENT:

Principal Investigator plans to follow patients for 6 months and create report (white paper) on OR experiences and 6 month follow-up. The study is a direct observation of 6 month follow-up for patients undergoing CEA with patch arterioplasty. No control group is included in the study, and no comparative analysis is planned.

DATA MONITORING Internal monitoring will be conducted periodically. CRF's, source documents, informed consent forms, and study deviations will be included; these findings will be reported to the PI. Deviations will be documented and reported according to IRB policy. Regulatory documents will be audited by the Baylor Research Institute Department of Research Compliance upon request.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Texas
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients needing a carotid endarterectomy with patch arterioplasty

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
OR Data and Surgeon Feedback During the Procedure	The OR data from the procedure including blood loss and how long it took to achieve hemostasis in addition to surgeon feedback on bleeding, handling, and suturing of the material will be collected on a source worksheet.	procedure

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Collaborators: Admedus Regen Pty Ltd.
• Investigators: Principal Investigator: Dennis Gable, MD, Baylor Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): April 24, 2017
• Study Completion (Actual): September 21, 2017

Study Registration Dates

• First Submitted: January 22, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimate): February 12, 2016

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 015-236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO