Trial Outcomes & Findings for Post-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular Surgery (NCT NCT03669042)

NCT ID: NCT03669042

Last Updated: 2024-10-08

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 94 participants
• Primary outcome timeframe: Up to 6 months, post-op
• Results posted on: 2024-10-08

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	94
Overall Study COMPLETED	94
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Treatment n=94 Participants 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
Age, Continuous	69.5 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	85 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	94 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Carotid Artery Stenosis n=78 Participants Indication for surgery was carotid artery stenosis
Incidence of Central Neurologic Events	2 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Carotid Artery Stenosis n=16 Participants Indication for surgery was carotid artery stenosis
Primary Patency	16 participants with primary patency

SECONDARY outcome

Timeframe: Up to 6 months, post-op

Percent of patients surviving

Outcome measures

Measure	Carotid Artery Stenosis n=94 Participants Indication for surgery was carotid artery stenosis
Overall Survival	94 Participants

SECONDARY outcome

Timeframe: Up to 6 months, post-op

Percent of patients requiring re-operations

Outcome measures

Measure	Carotid Artery Stenosis n=94 Participants Indication for surgery was carotid artery stenosis
All-Cause Re-operation Rate	1 Participants

SECONDARY outcome

Timeframe: Up to 6 months, post-op

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

Outcome measures

Measure	Carotid Artery Stenosis n=94 Participants Indication for surgery was carotid artery stenosis
Device-Related Re-operation Rate	0 Participants

SECONDARY outcome

Timeframe: Up to 6 months, post-op

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

Outcome measures

Measure	Carotid Artery Stenosis n=94 Participants Indication for surgery was carotid artery stenosis
Explant Rate	0 Participants

SECONDARY outcome

Timeframe: Up to 6 months, post-op

Percent of patients who experienced at least one adverse event.

Outcome measures

Measure	Carotid Artery Stenosis n=94 Participants Indication for surgery was carotid artery stenosis
Adverse Event Rate	28 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Carotid Artery Stenosis n=94 Participants Indication for surgery was carotid artery stenosis
Restenosis Rate	4 Participants

SECONDARY outcome

Timeframe: Up to 6 months, post-op

Population: No patients were enrolled for hemodialysis access repair.

For all hemodialysis access repairs only: Time from implantation to the point where the access is abandoned.

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 12 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment n=94 participants at risk 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
Surgical and medical procedures Bleeding event	2.1% 2/94 • Number of events 2 • Last visit for enrolled patients was 6 months.
Cardiac disorders cardiac event	2.1% 2/94 • Number of events 2 • Last visit for enrolled patients was 6 months.
Infections and infestations Infection	4.3% 4/94 • Number of events 4 • Last visit for enrolled patients was 6 months.
Vascular disorders Stroke	2.1% 2/94 • Number of events 2 • Last visit for enrolled patients was 6 months.
Vascular disorders Thrombosis	1.1% 1/94 • Number of events 1 • Last visit for enrolled patients was 6 months.
Vascular disorders Transient Ischemic Attack	1.1% 1/94 • Number of events 1 • Last visit for enrolled patients was 6 months.
Surgical and medical procedures Other	5.3% 5/94 • Number of events 8 • Last visit for enrolled patients was 6 months.
Vascular disorders Symptomatic Carotid Occlusion	1.1% 1/94 • Number of events 1 • Last visit for enrolled patients was 6 months.

Other adverse events

Measure	Treatment n=94 participants at risk 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
Cardiac disorders cardiac event	3.2% 3/94 • Number of events 3 • Last visit for enrolled patients was 6 months.
Surgical and medical procedures Bleeding event	1.1% 1/94 • Number of events 1 • Last visit for enrolled patients was 6 months.
Infections and infestations Infection	2.1% 2/94 • Number of events 2 • Last visit for enrolled patients was 6 months.
Blood and lymphatic system disorders Inflammation/Edema	1.1% 1/94 • Number of events 1 • Last visit for enrolled patients was 6 months.
General disorders Pain	5.3% 5/94 • Number of events 5 • Last visit for enrolled patients was 6 months.
General disorders Other	11.7% 11/94 • Number of events 14 • Last visit for enrolled patients was 6 months.

Additional Information

Karen Sylvester

Artivion, Inc.

Phone: 7704193355

Email: karen.sylvester@artivion.com

Results disclosure agreements

• Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
• Publication restrictions are in place

Restriction type: OTHER