Post-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular Surgery (PHOTO-V)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03669042|
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : April 22, 2019
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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).
PhotoFix Patch Implantation
- 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).
- 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.
- Overall Survival [ Time Frame: Up to 6 months, post-op ]Percent of patients surviving
- All-Cause Re-operation Rate [ Time Frame: Up to 6 months, post-op ]Percent of patients requiring re-operations
- 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.
- 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.
- Adverse Event Rate [ Time Frame: Up to 6 months, post-op ]Percent of patients who experienced at least one adverse event.
- 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.
- 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.
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
|Contact: Erin Hurley, MSPHfirstname.lastname@example.org|
|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|
|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|
|Principal Investigator:||Nicholas J. Morrissey, MD||Columbia University|