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

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

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.

Study Overview

• Status: Completed
• Conditions: Vascular Diseases; Peripheral Arterial Disease; Carotid Artery Diseases; Abdominal Aortic Aneurism; Hemodialysis Access Failure (Disorder)
• Intervention / Treatment: Device: PhotoFix

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • Iowa
    • Des Moines, Iowa, United States, 50266
      • Iowa Heart Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska
  • New York
    • New York, New York, United States, 10032
      • Columbia University
  • Ohio
    • Toledo, Ohio, United States, 43604
      • Jobst Vascular Institute
  • Texas
    • Temple, Texas, United States, 76508
      • Baylor Scott & White
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: PhotoFix; PhotoFix Patch Implantation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CryoLife, Inc.
• Investigators: Principal Investigator: Nicholas J. Morrissey, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2018
• Primary Completion (Actual): July 10, 2020
• Study Completion (Actual): July 10, 2020

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 16, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Aortic Diseases; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Carotid Artery Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: PHF1801.000-M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes