Back to resultsPost-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular Surgery (PHOTO-V)
Primary Purpose
Vascular Diseases, Peripheral Arterial Disease, Hemodialysis Access Failure (Disorder)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PhotoFix
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Diseases
Eligibility Criteria
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
Sites / Locations
- University of Arizona
- Iowa Heart Center
- Brigham and Women's Hospital
- University of Michigan
- University of Nebraska
- Columbia University
- Jobst Vascular Institute
- Baylor Scott & White
- University of Utah
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
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).
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Overall Survival
Percent of patients surviving
All-Cause Re-operation Rate
Percent of patients requiring re-operations
Device-Related Re-operation Rate
Percent of patients requiring unplanned re-operations that are documented as possibly, probably or definitely, device-related.
Explant Rate
Percent of patients requiring device explants. Explants will include the removal of PhotoFix for any reason after implantation.
Adverse Event Rate
Percent of patients who experienced at least one adverse event.
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.
Secondary Patency
For all hemodialysis access repairs only: Time from implantation to the point where the access is abandoned.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03669042
Brief Title
Post-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular Surgery
Acronym
PHOTO-V
Official Title
Post-market, Prospective Evaluation of PHOTO-oxidized Decellularized Bovine Pericardium Used as a Patch in Vascular Repair and Reconstruction Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
July 10, 2020 (Actual)
Study Completion Date
July 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CryoLife, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases, Peripheral Arterial Disease, Hemodialysis Access Failure (Disorder), Carotid Artery Diseases, Abdominal Aortic Aneurism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
PhotoFix
Intervention Description
PhotoFix Patch Implantation
Primary Outcome Measure Information:
Title
Incidence of Central Neurologic Events
Description
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
Title
Primary Patency
Description
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.
Time Frame
Up to 6 months, post-op
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Percent of patients surviving
Time Frame
Up to 6 months, post-op
Title
All-Cause Re-operation Rate
Description
Percent of patients requiring re-operations
Time Frame
Up to 6 months, post-op
Title
Device-Related Re-operation Rate
Description
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
Title
Explant Rate
Description
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
Title
Adverse Event Rate
Description
Percent of patients who experienced at least one adverse event.
Time Frame
Up to 6 months, post-op
Title
Restenosis Rate
Description
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
Title
Secondary Patency
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas J. Morrissey, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Iowa Heart Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Jobst Vascular Institute
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43604
Country
United States
Facility Name
Baylor Scott & White
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular Surgery
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