Vascular DiseasesPHOTO-VNCT03669042

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

A study testing PhotoFix in people with Vascular Diseases and Peripheral Arterial Disease, run by Artivion Inc. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Vascular Diseases, Peripheral Arterial Disease, Hemodialysis Access Failure (Disorder)
What is being tested?: PhotoFix
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 9 sitesUnited States
Study dates: 20 Nov 2018to 10 Jul 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Vascular Diseases, Peripheral Arterial Disease, Hemodialysis Access Failure (Disorder), Carotid Artery Diseases, Abdominal Aortic Aneurism
Being tested: PhotoFix
Medical subject headings: Vascular Diseases, Peripheral Arterial Disease, Carotid Artery Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PhotoFixDevice
PhotoFix Patch Implantation

Study groups in NCT03669042
Study group	Role	What they receive
Treatment	Experimental	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). Receives: Device: PhotoFix

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Up to 6 months, post-op
Primary Patency
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.
Measured: Up to 6 months, post-op

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 201810 Jul 2020

First posted13 Sep 2018
Study start20 Nov 2018
Primary completion10 Jul 2020
Study completion10 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Vascular DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03669042
Sponsor's protocol ID: PHF1801.000-M
Acronym: PHOTO-V
Status last verified: Sep 2024
First submitted: 11 Sep 2018
Last updated: 8 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)

All Vascular Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-market, Prospective Evaluation of PHOTO-oxidized Decellularized Bovine Pericardium Used as a Patch in Vascular Repair and Reconstruction Surgery
ClinicalTrials.gov ID: NCT03669042
Acronym / sponsor ID: PHOTO-V / PHF1801.000-M
Conditions: Vascular Diseases, Peripheral Arterial Disease, Hemodialysis Access Failure (Disorder), Carotid Artery Diseases, Abdominal Aortic Aneurism
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Artivion Inc.Industry (pharma, biotech, devices)
Study start: 20 Nov 2018 (actual)
Primary completion: 10 Jul 2020 (actual)
Study completion: 10 Jul 2020 (actual)
First posted: 13 Sep 2018 (actual)
Results: Posted 8 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Experimental	Device: PhotoFixAll 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PhotoFixPhotoFix Patch Implantation	Device	Treatment

Primary outcome

Incidence of Central Neurologic Events
Time frame: 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
Time frame: 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.

7 secondary outcomes

Overall Survival
Time frame: Up to 6 months, post-op
All-Cause Re-operation Rate
Time frame: Up to 6 months, post-op
Device-Related Re-operation Rate
Time frame: Up to 6 months, post-op
Explant Rate
Time frame: Up to 6 months, post-op
Adverse Event Rate
Time frame: Up to 6 months, post-op
Restenosis Rate
Time frame: Up to 6 months, post-op
Secondary Patency
Time frame: Up to 6 months, post-op

Results and safety

Results posted to the registry on 8 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	94	94

Primary outcome: Incidence of Central Neurologic Events

Time frame: Up to 6 months, post-op. Count of participants. Unit: Participants

Measure	Carotid Artery Stenosis n = 78
Value	2

Primary outcome: Primary Patency

Time frame: Up to 6 months, post-op. Number. Unit: participants with primary patency

Measure	Peripheral Arterial Disease n = 16
Value	16

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Last visit for enrolled patients was 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	12 of 94 (12.8%)	21 of 94 (22.3%)	0 of 94

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Vascular Diseases

Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nicholas J. Morrissey, MD principal investigator

Columbia University

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PhotoFix in people with Vascular Diseases and Peripheral Arterial Disease, run by Artivion Inc. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Central Neurologic Events (time frame: Up to 6 months, post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03669042.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.