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

Peripheral Arterial Disease Clinical Trial

— PHOTO-V  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669042
• Other study ID #: PHF1801.000-M
• Status: Completed
• Phase: N/A
• Start date: November 20, 2018
• Est. completion date: July 10, 2020

Study information

• Verified date: July 2020
• Source: CryoLife, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 10, 2020
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• PhotoFix
PhotoFix Patch Implantation

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Iowa Heart Center	Des Moines	Iowa
United States	Columbia University	New York	New York
United States	University of Nebraska	Omaha	Nebraska
United States	University of Utah	Salt Lake City	Utah
United States	Baylor Scott & White	Temple	Texas
United States	Jobst Vascular Institute	Toledo	Ohio
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
CryoLife, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Overall Survival	Percent of patients surviving	Up to 6 months, post-op
Secondary	All-Cause Re-operation Rate	Percent of patients requiring re-operations	Up to 6 months, post-op
Secondary	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
Secondary	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
Secondary	Adverse Event Rate	Percent of patients who experienced at least one adverse event.	Up to 6 months, post-op
Secondary	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	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