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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03669042

Acronym

PHOTO-V

Enrollment

Registered

2018-09-13

Start date

2018-11-20

Completion date

2020-07-10

Last updated

2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEPhotoFix

PhotoFix Patch Implantation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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): 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

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

Countries

United States

Participant flow

Participants by arm

Arm	Count
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). PhotoFix: PhotoFix Patch Implantation	94
Total	94

Baseline characteristics

Characteristic	Treatment
Age, Continuous	69.5 years STANDARD_DEVIATION 8.3
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	2 Participants
Race (NIH/OMB) Black or African American	4 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants
Race (NIH/OMB) White	85 Participants
Region of Enrollment United States	94 Participants
Sex: Female, Male Female	38 Participants
Sex: Female, Male Male	56 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 94
other Total, other adverse events	21 / 94
serious Total, serious adverse events	12 / 94

Outcome results

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).