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Trial record 79 of 113 for:    Recruiting, Not yet recruiting, Available Studies | Common carotid artery

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

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ClinicalTrials.gov Identifier: NCT03669042
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
CryoLife, Inc.

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.

Condition or disease Intervention/treatment Phase
Vascular Diseases Peripheral Arterial Disease Hemodialysis Access Failure (Disorder) Carotid Artery Diseases Abdominal Aortic Aneurism Device: PhotoFix Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-market, Prospective Evaluation of PHOTO-oxidized Decellularized Bovine Pericardium Used as a Patch in Vascular Repair and Reconstruction Surgery
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
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
PhotoFix Patch Implantation




Primary Outcome Measures :
  1. Incidence of Central Neurologic Events [ Time Frame: Up to 6 months, post-op ]
    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).

  2. Primary Patency [ Time Frame: Up to 6 months, post-op ]
    For all other procedures (non-CEAs): Time from PhotoFix implantation to the time when patency in the vessel is documented as lost. 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.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 6 months, post-op ]
    Percent of patients surviving

  2. All-Cause Re-operation Rate [ Time Frame: Up to 6 months, post-op ]
    Percent of patients requiring re-operations

  3. Device-Related Re-operation Rate [ Time Frame: Up to 6 months, post-op ]
    Percent of patients requiring unplanned re-operations that are documented as possibly, probably or definitely, device-related.

  4. Explant Rate [ Time Frame: Up to 6 months, post-op ]
    Percent of patients requiring device explants. Explants will include the removal of PhotoFix for any reason after implantation.

  5. Adverse Event Rate [ Time Frame: Up to 6 months, post-op ]
    Percent of patients who experienced at least one adverse event.

  6. Restenosis Rate [ Time Frame: Up to 6 months, post-op ]
    Percent of patients who develop stenosis. Stenosis is considered as the recurrence of abnormal narrowing of an artery or vein after corrective surgery. Categorization of stenosis ≥ 50% will occur if data is available.

  7. Secondary Patency [ Time Frame: Up to 6 months, post-op ]
    For all hemodialysis access repairs only: Time from implantation to the point where the access is abandoned.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 or unwilling to use medically acceptable methods of birth control
  • Patient's procedure is emergent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669042


Contacts
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Contact: Erin Hurley, MSPH 800-438-8285 hurley.erin@cryolife.com

Locations
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United States, Arizona
University of Arizona Not yet recruiting
Tucson, Arizona, United States, 85724
Contact: Wei Zhou, MD         
United States, Iowa
Iowa Heart Center Recruiting
Des Moines, Iowa, United States, 50266
Contact: Jose Borromeo, MD, FACS         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Michael Belkin, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Nicholas Osborne, MD,MS         
United States, Nebraska
University of Nebraska Recruiting
Omaha, Nebraska, United States, 68198
Contact: Nitin Garg, MBBS, MPH         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Nicholas Morrissey, MD         
United States, Ohio
Jobst Vascular Institute Recruiting
Toledo, Ohio, United States, 43604
Contact: Todd Russell, MD, FACS         
United States, Texas
Baylor Scott & White Not yet recruiting
Temple, Texas, United States, 76508
Contact: William Bohannon, MD, FACS         
United States, Utah
University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84132
Contact: Larry Kraiss, MD         
Sponsors and Collaborators
CryoLife, Inc.
Investigators
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Principal Investigator: Nicholas J. Morrissey, MD Columbia University

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Responsible Party: CryoLife, Inc.
ClinicalTrials.gov Identifier: NCT03669042     History of Changes
Other Study ID Numbers: PHF1801.000-M
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Carotid Artery Diseases
Peripheral Arterial Disease
Arterial Occlusive Diseases
Aneurysm
Aortic Aneurysm
Vascular Diseases
Peripheral Vascular Diseases
Aortic Aneurysm, Abdominal
Cardiovascular Diseases
Aortic Diseases
Atherosclerosis
Arteriosclerosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases