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

Not Applicable

Completed

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

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment	PhotoFix	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).

Primary Outcome Measures

Name	Time	Method
Incidence of Central Neurologic Events	Up to 6 months, post-op	For cases of carotid endarterectomy (CEA) only: Percent of patients who experienced at least one of the central neurologic events of interest (transient ischemic attack, amaurosis fugax, stroke, carotid occlusion).
Primary Patency	Up to 6 months, post-op	For all other procedures (non-CEAs): Loss of patency includes loss of previously palpable pulses, presentation of recurrent symptoms, a drop in ABI\>0.15 in the case of lower limb artery repair, Doppler ultrasound findings of occlusion, angiography of the affected vessel or a combination of these. Loss of patency will also be considered if an intervention to restore or maintain patency is documented.

Secondary Outcome Measures

Name	Time	Method
Device-Related Re-operation Rate	Up to 6 months, post-op	Percent of patients requiring unplanned re-operations that are documented as possibly, probably or definitely, device-related.
Secondary Patency	Up to 6 months, post-op	For all hemodialysis access repairs only: Time from implantation to the point where the access is abandoned.
Explant Rate	Up to 6 months, post-op	Percent of patients requiring device explants. Explants will include the removal of PhotoFix for any reason after implantation.
All-Cause Re-operation Rate	Up to 6 months, post-op	Percent of patients requiring re-operations
Adverse Event Rate	Up to 6 months, post-op	Percent of patients who experienced at least one adverse event.
Overall Survival	Up to 6 months, post-op	Percent of patients surviving
Restenosis Rate	Up to 6 months, post-op	Percent of patients who develop stenosis. Stenosis is considered as the recurrence of abnormal narrowing of an artery or vein after corrective surgery. Categorization of stenosis ≥ 50% will occur if data is available.

Locations (9): Iowa Heart Center
🇺🇸
Des Moines, Iowa, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
Columbia University
🇺🇸
New York, New York, United States
University of Utah
🇺🇸
Salt Lake City, Utah, United States
Jobst Vascular Institute
🇺🇸
Toledo, Ohio, United States
Baylor Scott & White
🇺🇸
Temple, Texas, United States
University of Arizona
🇺🇸
Tucson, Arizona, United States
University of Nebraska
🇺🇸
Omaha, Nebraska, United States