NCT03669042: PHOTO-V

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

Completed NA Results posted Last updated 8 October 2024

What this trial tests

NA trial testing PhotoFix in Vascular Diseases in 94 participants. Completed in 10 July 2020.

Timeline

20 November 2018

Primary endpoint
10 July 2020

10 July 2020

Quick facts

Lead sponsor	Artivion Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	94
Start date	20 November 2018
Primary completion	10 July 2020
Estimated completion	10 July 2020
Sites	9 locations across United States

Drugs / interventions tested

• PhotoFix

Conditions studied

• Vascular Diseases — all drugs for Vascular Diseases →
• Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →
• Hemodialysis Access Failure (Disorder) — all drugs for Hemodialysis Access Failure (Disorder) →
• Carotid Artery Diseases — all drugs for Carotid Artery Diseases →

Sponsor

Artivion Inc.

Who can join

18 and older, any sex, with Vascular Diseases or Peripheral Arterial Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Central Neurologic Events Primary · 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).

Group	Value	95% CI
Carotid Artery Stenosis	2

Primary Patency Primary · 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.

Group	Value	95% CI
Peripheral Arterial Disease	16

Overall Survival Secondary · Up to 6 months, post-op

Percent of patients surviving

Group	Value	95% CI
Treatment	94

All-Cause Re-operation Rate Secondary · Up to 6 months, post-op

Percent of patients requiring re-operations

Group	Value	95% CI
Treatment	1

Device-Related Re-operation Rate Secondary · Up to 6 months, post-op

Percent of patients requiring unplanned re-operations that are documented as possibly, probably or definitely, device-related.

Group	Value	95% CI
Treatment	0

Explant Rate Secondary · Up to 6 months, post-op

Percent of patients requiring device explants. Explants will include the removal of PhotoFix for any reason after implantation.

Group	Value	95% CI
Treatment	0

Adverse Event Rate Secondary · Up to 6 months, post-op

Percent of patients who experienced at least one adverse event.

Group	Value	95% CI
Treatment	28

Restenosis Rate Secondary · 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.

Group	Value	95% CI
Treatment	4

Adverse events — posted to ClinicalTrials.gov

Time frame: Last visit for enrolled patients was 6 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment

Serious: 12/94 (13%)

Deaths: 0/94

Serious adverse events (8 terms)

Reaction	System	Treatment
Other	Surgical and medical procedures	—
Infection	Infections and infestations	—
Bleeding event	Surgical and medical procedures	—
cardiac event	Cardiac disorders	—
Stroke	Vascular disorders	—
Thrombosis	Vascular disorders	—
Transient Ischemic Attack	Vascular disorders	—
Symptomatic Carotid Occlusion	Vascular disorders	—

Other adverse events (6 terms — click to expand)

Reaction	System	Treatment
Other	General disorders	—
Pain	General disorders	—
cardiac event	Cardiac disorders	—
Infection	Infections and infestations	—
Bleeding event	Surgical and medical procedures	—
Inflammation/Edema	Blood and lymphatic system disorders	—

Most-reported serious reactions: Other, Infection, Bleeding event, cardiac event, Stroke, Thrombosis, Transient Ischemic Attack, Symptomatic Carotid Occlusion.

Data from ClinicalTrials.gov NCT03669042 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Acellular Extracellular Matrix Bioscaffolds for Cardiac Repair and Regeneration.
   Pattar SS, Fatehi Hassanabad A, Fedak PWM. · · 2019 · cited 40× · PMID 31080800 · DOI 10.3389/fcell.2019.00063