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

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT03669042

Run by

Artivion Inc.

People needed

94

Starts

2018-11-20

Expected to finish

2020-07-10

Last updated by the study team

2024-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arizona — Tucson, Arizona, United States
• Iowa Heart Center — Des Moines, Iowa, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Nebraska — Omaha, Nebraska, United States
• Columbia University — New York, New York, United States
• Jobst Vascular Institute — Toledo, Ohio, United States
• Baylor Scott & White — Temple, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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