Clinical trial NCT03669042: Post-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular Surgery
Official title: Post-market, Prospective Evaluation of PHOTO-oxidized Decellularized Bovine Pericardium Used as a Patch in Vascular Repair and Reconstruction Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Diseases
Peripheral Arterial Disease
Hemodialysis Access Failure (Disorder)
Carotid Artery Diseases
Abdominal Aortic Aneurism
Lead sponsor: Artivion Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-13
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Central Neurologic Events
timeFrame: Up to 6 months, post-op
measure: Primary Patency
timeFrame: Up to 6 months, post-op
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to 6 months, post-op
measure: All-Cause Re-operation Rate
timeFrame: Up to 6 months, post-op
measure: Device-Related Re-operation Rate
timeFrame: Up to 6 months, post-op
measure: Explant Rate
timeFrame: Up to 6 months, post-op
measure: Adverse Event Rate
timeFrame: Up to 6 months, post-op
measure: Restenosis Rate
timeFrame: Up to 6 months, post-op
measure: Secondary Patency
timeFrame: Up to 6 months, post-op
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: New York
country: United States
facility: Columbia University
state: New York
city: Toledo
country: United States
facility: Jobst Vascular Institute
state: Ohio
city: Temple
country: United States
facility: Baylor Scott & White
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Columbia University
name: Nicholas J. Morrissey, MD
role: PRINCIPAL_INVESTIGATOR
References: