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

Study Overview
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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.

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.

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

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

Intervention / Treatment
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* Device: PhotoFix


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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). | Device: PhotoFix<br>* PhotoFix Patch Implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Up to 6 months, post-op | 
| Primary Patency | For all other procedures (non-CEAs): Time from PhotoFix implantation to the time when patency in the vessel is documented as lost. 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. | Up to 6 months, post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Percent of patients surviving | Up to 6 months, post-op | 
| All-Cause Re-operation Rate | Percent of patients requiring re-operations | 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. | 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. | Up to 6 months, post-op | 
| Adverse Event Rate | Percent of patients who experienced at least one adverse event. | 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. | 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. | Up to 6 months, post-op |