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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
94
PhotoFix Patch Implantation
University of Arizona
Tucson, Arizona, United States
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
Incidence of Central Neurologic Events
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).
Time frame: Up to 6 months, post-op
Primary Patency
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.
Time frame: Up to 6 months, post-op
Overall Survival
Percent of patients surviving
Time frame: Up to 6 months, post-op
All-Cause Re-operation Rate
Percent of patients requiring re-operations
Time frame: Up to 6 months, post-op
Device-Related Re-operation Rate
Percent of patients requiring unplanned re-operations that are documented as possibly, probably or definitely, device-related.
Time frame: Up to 6 months, post-op
Explant Rate
Percent of patients requiring device explants. Explants will include the removal of PhotoFix for any reason after implantation.
Time frame: Up to 6 months, post-op
Adverse Event Rate
Percent of patients who experienced at least one adverse event.
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University of Nebraska
Omaha, Nebraska, United States
Columbia University
New York, New York, United States
Jobst Vascular Institute
Toledo, Ohio, United States
Baylor Scott & White
Temple, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Time frame: Up to 6 months, post-op
Restenosis Rate
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.
Time frame: Up to 6 months, post-op
Secondary Patency
For all hemodialysis access repairs only: Time from implantation to the point where the access is abandoned.
Time frame: Up to 6 months, post-op