Post-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular Surgery



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology, Cardiology, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:November 20, 2018
End Date:April 2020
Contact:Erin Hurley, MSPH
Email:hurley.erin@cryolife.com
Phone:800-438-8285

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Post-market, Prospective Evaluation of PHOTO-oxidized Decellularized Bovine Pericardium Used as a Patch in Vascular Repair and Reconstruction Surgery

The objective of this post-market clinical follow-up study is to evaluate the clinical
outcomes of patients receiving PhotoFix as a patch within a vascular repair or reconstruction
procedure.

PhotoFix is prepared from bovine pericardium, which is stabilized using a dye-mediated
photo-oxidation process and sterilized using aseptic processing techniques. The primary
endpoint for patients with carotid artery stenosis (CAS) undergoing carotid endarterectomies
(CEA) will be rate of ipsilateral central neurologic events; the primary endpoint for all
other vascular procedures will be primary patency. The secondary endpoints include all-cause
reoperation rate, device-related reoperation rate, explant rate, restenosis rate, secondary
patency (hemodialysis access repair (HAR) only) and survival. A goal of 100 patients will be
enrolled at approximately 10 sites. The enrollment period will span a minimum of 8 months
from Institutional Review Board (IRB) approval and site activation. Candidates for this study
are adults who require vascular repair or reconstruction surgery that necessitates the use of
a patch. Patients will be consented pre-operatively and enrolled patients will be followed
for approximately 6 months after PhotoFix surgery. Data will be collected at 5 time points:
baseline (pre-operatively), intra-operatively, 1 month post-operatively, 3 months
post-operatively, and 6 months post-operatively.

Inclusion Criteria:

- Patient is undergoing a vascular procedure which falls within the indications for use
and requires the use of PhotoFix Decellularized Bovine Pericardium

- Patient's surgery is anticipated to occur within 60 days of consent

- Patient is ≥18 years old

- Patient is willing and able to comply with the protocol and follow up period

- Patient is willing and able to give written informed consent

Exclusion Criteria:

- Patient's procedure is a revision of a prior arteriotomy or venotomy

- Patient's procedure requires multiple vascular patches in anatomically distinct
regions or other prosthetics (e.g. stents)

- Patient has a medical history of abnormal coagulopathy, bleeding, or thromboembolic
disease

- Patient has a medical history of severe immunodeficiency disease

- Patient has a medical history of cancer

- Patient has severe visceral disease in heart or active liver disease or icterus

- Patient has a history of cerebrovascular accident (completed stroke) within 3 months
of planned surgery

- Patient has a history of atrial fibrillation and requires a patch for carotid
endarterectomy repair

- Patient has an active or potential infection at the surgical site

- Patient has used or plans to use immunomodulatory drugs for ≥ 6 months

- Patient has a sensitivity to products of bovine origin

- Patient is currently enrolled in another study

- Patient has a life expectancy of less than 12 months

- Patient is pregnant or breastfeeding or planning on becoming pregnant or unwilling to
use medically acceptable methods of birth control

- Patient's procedure is emergent
We found this trial at
5
sites
Toledo, Ohio 43606
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Toledo, OH
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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Des Moines, Iowa 50314
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Des Moines, IA
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Omaha, Nebraska 68198
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Omaha, NE
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