The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of fenestrations and/or branches to repair aortic aneurysm.
This is a traditional device feasibility study intended to generate preliminary safety and efficacy information that may be used to plan an appropriate future study, or to inform further product development. Subjects will have been diagnosed with a bulge or aneurysm in their aortic arch and or abdominal aorta, which is the blood vessel in the abdomen (belly) that supplies blood to most of the lower body including major organs and the legs. The Zenith t-Branch and physician-specified fenestrated and branched endovascular graft is a tubular graft made of polyester fabric sewn to stainless steel stents that keep the graft open. As an aneurysm expands, the walls become weak and may rupture, causing a major loss of blood with a high risk of death and other serious complications. To avoid this risk the aneurysm will be repaired by putting a graft inside the aneurysm. The graft will be inserted through arteries in the groin (called endovascular repair). This procedure uses catheters that go inside the blood vessel to place a stent-graft above and below the aneurysm. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches). These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches. The Zenith t-Branch and physician-specified fenestrated and branched endovascular graft will be referred to as the Zenith Fenestrated-Branched System.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
760
The Zenith Fenestrated-Branched System is a tubular graft made of polyester fabric sewn to stainless steel stents that keep the graft open. The graft will be inserted through arteries in the leg (called endovascular repair). This procedure uses catheters that go inside the blood vessel to place a stent graft above and below the aneurysm. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches). One or more than one of the study devices including the Zenith® Fenestrated AAA Endovascular Graft, Zenith® t-Branch Endovascular Graft, Patient-Specific Thoracoabdominal Graft, Patient-Specific Distal Bifurcated Component, and Zenith® Branch Endovascular Graft-Iliac Bifurcation will be implanted. The arteries to the liver, intestine, and kidneys will have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.
The Zenith® Arch Branch Endovascular Graft includes the main aortic arch portion and one to three cuffs (side branches) that allow the graft to be located in the aortic arch. The number of cuffs is decided based on the anatomy of your aneurysm. The arteries in the aortic arch are the innominate artery (Zone 0), left common carotid artery (Zone 1) and the left subclavian artery (Zone 2). These arteries supply the right arm and right side of the brain, the left side of the brain and the left arm, respectively. The main aortic endovascular graft will be connected into the innominate artery, left common carotid artery and left subclavian artery using additional stents into the branch vessels.
Mayo Clinic
Rochester, Minnesota, United States
ACTIVE_NOT_RECRUITINGBaylor College of Medicine
Houston, Texas, United States
RECRUITINGUniversity of Texas Health Science Center at Houston
Houston, Texas, United States
ACTIVE_NOT_RECRUITINGNumber of subjects who have died at 30 days post treatment
Deaths 30 days after treatment
Time frame: 30 days post treatment
Number of subjects who experience a Major Adverse Event at 30 days post treatment
A Major Adverse Event includes any of the following: bowel ischemia, myocardial infarction (heart attack), paraplegia, renal failure, respiratory failure, stroke, or blood loss greater than 1000 ml.
Time frame: 30 days post treatment
Percentage of subjects who achieve treatment success
Treatment success is defined by a composite endpoint, which includes all the following criteria: 1) technical success, defined as successful delivery and deployment of the custom-made endovascular graft with preservation of those branch vessels intended to be preserved; 2) freedom from type I or III endoleak; 3) freedom from stent-graft migration; 4) freedom from aneurysm enlargement \>5 mm; 5) freedom from aneurysm rupture or conversion to open repair.
Time frame: 12 months post treatment
Mean Quality of Life Measure at Various Time Points
Subjects complete the Short-Form General Health Survey (SF-36) form which consists of an 11 question survey that is divided into 2 parts: physical and emotional. The scale scores range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).
Time frame: Pre-procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
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