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

Sponsor

CryoLife, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03669042

Collaborator

(none)

Enrollment

Locations

Arm

19.6

Actual Duration (Months)

10.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Diseases Peripheral Arterial Disease Hemodialysis Access Failure (Disorder) Carotid Artery Diseases Abdominal Aortic Aneurism	Device: PhotoFix	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

94 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 20, 2018

Actual Primary Completion Date :

Jul 10, 2020

Actual Study Completion Date :

Jul 10, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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): 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 [Up to 6 months, post-op]
Percent of patients surviving
All-Cause Re-operation Rate [Up to 6 months, post-op]
Percent of patients requiring re-operations
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.
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.
Adverse Event Rate [Up to 6 months, post-op]
Percent of patients who experienced at least one adverse event.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona	Tucson	Arizona	United States	85724
2	Iowa Heart Center	Des Moines	Iowa	United States	50266
3	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
4	University of Michigan	Ann Arbor	Michigan	United States	48109
5	University of Nebraska	Omaha	Nebraska	United States	68198
6	Columbia University	New York	New York	United States	10032
7	Jobst Vascular Institute	Toledo	Ohio	United States	43604
8	Baylor Scott & White	Temple	Texas	United States	76508
9	University of Utah	Salt Lake City	Utah	United States	84132