Endurant Evo International Clinical Trial<br>
- Conditions
- Enlargement of the abdominal aorta10002363
- Registration Number
- NL-OMON47483
- Lead Sponsor
- Medtronic B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 21
- Subject is at least 18 years old
- Subject is a suitable candidate for elective surgical repair of AAA as
evaluated by American Society of Anesthesiologists (ASA) Physical Status
Classification System I, II, or III
- Subject has an infrarenal abdominal aortic or aortoiliac aneurysm
characterized by one or more of the following:
a) Aneurysm is > 5 cm in diameter (diameter measured is perpendicular to the
line of flow)
b) Aneurysm is 4 * 5 cm in diameter and has increased in size * 0.5 cm within
the previous 6 months
- Subject meets all the following anatomical criteria as demonstrated on
contrast-enhanced CT or MRA imaging:
a) Proximal neck length of * 10 mm with * 60° infrarenal and * 45° suprarenal
neck angulation or Proximal neck length of * 15 mm with * 75° infrarenal and *
60° suprarenal neck angulation
b) Subject has vascular dimensions, e.g., aortic and iliac diameters, lengths
from renal arteries to iliac bifurcation and hypogastric arteries, in the range
of sizes available for the Endurant Evo AAA stent graft system (measured intima
to intima) and within the sizing recommendations (refer to Endurant Evo AAA
stent graft system Instructions for Use (IFU))
c) Subject has a proximal aortic neck diameter *18 mm and *32 mm
d) The distal fixation center of the iliac arteries must have a diameter *7 mm
and * 25 mm bilaterally for the bifur and unilaterally for the AUI
e) Subject has documented imaging evidence of at least one patent iliac and one
femoral artery, or can tolerate a vascular conduit that allows introduction of
the Endurant Evo AAA stent graft system
f) Subject has distal non-aneurysmal iliac (cylindrical) fixation length * 20
mm bilaterally for the bifur and unilaterally for the AUI
- Subject has a life expectancy * 1 year
- Subject has an aneurysm that is:
a. Suprarenal/ pararenal/ juxtarenal
b. Isolated ilio-femoral
c. Mycotic
d. Inflammatory
e. Pseudoaneurysm
f. Dissecting
g. Ruptured
h. Leaking but not ruptured
- Subject requires emergent aneurysm treatment
- Subject has a known, untreated thoracic aneurysm >4.5 cm in diameter at time
of screening
- Subject has been previously treated for an abdominal aortic aneurysm
- Subject has a history of bleeding diathesis or coagulopathy
- Subject has had or plans to have an unrelated major surgical or
interventional procedure within 1 month before or after implantation of the
Endurant Evo AAA Stent Graft
- Subject has had a myocardial infarction (MI) or cerebral vascular accident
(CVA) within 3 months prior to implantation of the Endurant Evo AAA Stent Graft
- Subject has a conical neck defined as a >4 mm distal increase from the
lowest renal artery over a 10 mm length
- Subject has a known allergy or intolerance to the device materials
- Subject has a known hypersensitivity or contraindication to anticoagulants,
antiplatelets, or contrast media, which is not amenable to pre-treatment
- Subject has significant aortic thrombus and/or calcification at either the
proximal or distal attachment centers that would compromise fixation and seal
of the device at the discretion of the investigator
- Subject has ectatic iliac arteries requiring bilateral exclusion of
hypogastric blood flow
- Subject whose arterial access site is not anticipated to accommodate the
diameter of the Endurant Evo AAA delivery system (13F-17F) due to vessel size,
calcification, or tortuosity
- Subject is morbidly obese or has other documented clinical conditions that
severely inhibit radiographic visualization of the aorta at the discretion of
the investigator
- Subject has active infection at the time of the index procedure documented by
e.g. pain, fever, drainage, positive culture and/or leukocytosis considered to
be clinically significant per investigator discretion
- Subject has congenital degenerative collagen disease, e.g., Marfan*s Syndrome
- Subject has a creatinine level >2.00 mg/dl (or >176.8 µmol/L)
- Subject is on dialysis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary safety endpoint:<br /><br>The primary safety endpoint is defined as the proportion of subjects<br /><br>experiencing an MAE within 30 days post-implantation. MAEs include the<br /><br>occurrence of any of the following events:<br /><br><br /><br>* All-cause mortality<br /><br>* Bowel ischemia<br /><br>* Myocardial infarction<br /><br>* Paraplegia<br /><br>* Procedural blood loss *1000 cc<br /><br>* Renal failure<br /><br>* Respiratory failure<br /><br>* Stroke<br /><br><br /><br>Primary effectiveness endpoint:<br /><br>Technical success at the index procedure (as assessed intra-operatively) is<br /><br>defined as successful delivery and deployment of the Endurant Evo AAA stent<br /><br>graft system in the planned location and with no unintentional coverage of both<br /><br>internal iliac arteries or any visceral aortic branches and with successful<br /><br>removal of the delivery system. </p><br>
- Secondary Outcome Measures
Name Time Method