NCT02418156

Brief Summary

To gather information on the use of CorMatrix ECM for Vascular Repair in the reconstruction of the femoral artery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

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

April 9, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
2 years until next milestone

Results Posted

Study results publicly available

February 11, 2020

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

2.8 years

First QC Date

April 9, 2015

Results QC Date

June 26, 2019

Last Update Submit

July 19, 2023

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

  • Device-Related Adverse Events

    Proportion of patients experiencing device related adverse events.

    Up to 12 months follow-up

Study Arms (1)

Single Arm

Subjects undergoing femoral arterial reconstruction using CorMatrix ECM for vascular repair.

Device: CorMatrix ECM for Vascular Repair

Interventions

CorMatrix ECM for Vascular RepairDEVICE

Standard femoral arterial interventional procedure using CorMatrix ECM for vascular repair.

Single Arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting for femoral arterial reconstruction with patch angioplasty.

You may qualify if:

  • Subjects must be undergoing femoral arterial reconstruction with patch angioplasty closure
  • Surgeon intends to use CorMatrix ECM per FDA cleared Indications for Use
  • Subject possesses ability to provide informed consent
  • Subject expresses understanding and willingness to fulfill all expected requirements of protocol

You may not qualify if:

  • \. Known sensitivity to porcine material

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Clinical Director
Organization
Aziyo Biolgics, Inc.
clinical@aziyo.com
470-514-4085

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

April 9, 2015

First Posted

April 16, 2015

Study Start

May 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

July 21, 2023

Results First Posted

February 11, 2020

Record last verified: 2023-07