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

NCT03669042 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2024-10-08

Study results available
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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.

Conditions

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

Interventions

DEVICE

PhotoFix

PhotoFix Patch Implantation

Sponsors & Collaborators

  • Artivion Inc.

    lead INDUSTRY

Principal Investigators

  • Nicholas J. Morrissey, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2020-07-10
Completion
2020-07-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03669042 on ClinicalTrials.gov