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

NCT03669042 | Completed Results FDA Device

• 1 other identifier: PHF1801.000-M
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 9

Brief 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

Outcome Measures

Primary Outcomes (2)

• Incidence of Central Neurologic Events

  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).

  Up to 6 months, post-op

• Primary Patency

  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.

  Up to 6 months, post-op

Secondary Outcomes (7)

• Overall Survival

  Up to 6 months, post-op

• All-Cause Re-operation Rate

  Up to 6 months, post-op

• Device-Related Re-operation Rate

  Up to 6 months, post-op

• Explant Rate

  Up to 6 months, post-op

• Adverse Event Rate

  Up to 6 months, post-op

Study Arms (1)

Treatment

EXPERIMENTAL

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).

Device: PhotoFix

Interventions

PhotoFix DEVICE

PhotoFix Patch Implantation

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Artivion Inc.: lead

Study Sites (9)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Iowa Heart Center

Des Moines, Iowa, 50266, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Nebraska

Omaha, Nebraska, 68198, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Jobst Vascular Institute

Toledo, Ohio, 43604, United States

Location

Baylor Scott & White

Temple, Texas, 76508, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Vascular Diseases; Peripheral Arterial Disease; Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Karen Sylvester
• Organization: Artivion, Inc.

karen.sylvester@artivion.com

7704193355

Study Officials

• Nicholas J. Morrissey, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 13, 2018
• Study Start: November 20, 2018
• Primary Completion: July 10, 2020
• Study Completion: July 10, 2020
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)