Post-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular Surgery (NCT03669042) | Clinical Trial Compass
CompletedNot Applicable
Post-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular Surgery
United States94 participantsStarted 2018-11-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 …