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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-20

Study Completion Date

2020-07-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vascular Diseases Peripheral Arterial Disease Hemodialysis Access Failure (Disorder) Carotid Artery Diseases Abdominal Aortic Aneurism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

All patients will undergo a vascular repair or reconstruction surgery, which requires the use of PhotoFix. The surgical procedures will vary by patient and by underlying etiology. Therefore, PhotoFix implant sites will also vary. In all cases, PhotoFix will be implanted per the Instructions for Use (IFU).

Group Type EXPERIMENTAL

PhotoFix

Intervention Type DEVICE

PhotoFix Patch Implantation

Interventions

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PhotoFix

PhotoFix Patch Implantation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No