NCT03669042

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Artivion Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	PhotoFix	PhotoFix Patch Implantation

Timeline

• Start date: 2018-11-20
• Primary completion: 2020-07-10
• Completion: 2020-07-10
• First posted: 2018-09-13
• Last updated: 2024-10-08
• Results posted: 2024-10-08

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study