The purpose of the Endurant Evo International Clinical Trial is to evaluate the safety and effectiveness of the Endurant Evo AAA Stent graft system for endovascular treatment of subjects with infrarenal abdominal aortic or aortoiliac aneurysms.
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary safety endpoint:
The primary safety endpoint is defined as the proportion of subjects
experiencing an MAE within 30 days post-implantation. MAEs include the
occurrence of any of the following events:
* All-cause mortality
* Bowel ischemia
* Myocardial infarction
* Paraplegia
* Procedural blood loss *1000 cc
* Renal failure
* Respiratory failure
* Stroke
Primary effectiveness endpoint:
Technical success at the index procedure (as assessed intra-operatively) is
defined as successful delivery and deployment of the Endurant Evo AAA stent
graft system in the planned location and with no unintentional coverage of both
internal iliac arteries or any visceral aortic branches and with successful
removal of the delivery system.
Secondary outcome
The following secondary endpoints will be evaluated:
* All cause-mortality within 30, 183, and 365 days
* Aneurysm-related mortality within 30, 183, and 365 days
* Secondary procedures to correct Type I and III endoleaks within 30 183 and
365 days
* Secondary endovascular procedures within 30, 183 and 365 days
* Serious adverse events within 30, 183 and 365 days
* Aneurysm rupture within 30, 183 and 365 days
* Conversion to open surgery within 30, 183 and 365 days
* Major adverse events within 183 and 365 days
* Stent graft migration at 12-month follow-up visit (as compared to 1-month
imaging)
* Aneurysm expansion > 5 mm at 12-month follow-up visit (as compared to 1-month
imaging).
* All endoleaks based on imaging findings at 1- month, 6-month and 12-month
visits.
* Stent graft occlusion based on imaging findings through 6 months and 12
months.
* Device deficiencies based on imaging findings through 6 months and 12- months.
Secondary endpoints will be assessed at annual follow-up visits until 5 years
post-implantation.
Background summary
Abdominal aortic aneurysms (AAA) occur in approximately 5% of the general
population as estimated by a systematic literature survey of 56 epidemiological
studies.The prevalence is greater in males compared with females and aneurysms
are found more frequently in western countries than in Asia. Risk factors for
AAA include advanced age, smoking, family history of AAA, hypertension,
atherosclerosis, and hyperlipidemia. The female gender and diabetes were
associated with a lower prevalence of AAA.
Aneurysms are prophylactically treated to prevent premature death from rupture.
More than one-third of patients with ruptured aneurysms succumb from the event;
a proportion that has not decreased appreciably over the last several decades.
By contrast, elective treatment of AAA prior to rupture is associated with a
perioperative mortality rate below 3%. For this reason, AAA are best managed
electively, prior to rupture.
There are two general methods for repair of an AAA; traditional open surgical
repair and endovascular repair. Traditional open surgical repair has been the
standard technique for over six decades. Open repair is performed through a
transperitoneal or retroperitoneal incision; sewing a prosthetic graft to the
aorta above and below the aneurysm. While durable, open repair is associated
with a significant risk of perioperative complications. The risk is
particularly high in the elderly and in those with multiple medical
comorbidities; the population who characteristically develop AAA.
Endovascular aneurysm repair (EVAR) is the second general technique for
aneurysm repair. The objective of EVAR is to repair the aneurysm through the
trans-vascular insertion of an endograft. EVAR has been shown to reduce 30-day
and in-hospital mortality, blood transfusions, mechanical ventilation, and ICU
and hospital length of stay compared to open surgery. Current endografts, while
much improved over earlier devices, still suffer from some shortcomings.
Medtronic*s next generation AAA stent graft system on the Endurant product
platform is the EndurantTM Evo Abdominal Aortic Aneurysm (AAA) stent graft
system. The Endurant Evo AAA stent graft system was designed to further expand
EVAR applicability and improve access in patients with challenging anatomies.
Study objective
The purpose of the Endurant Evo International Clinical Trial is to evaluate the
safety and effectiveness of the Endurant Evo AAA Stent graft system for
endovascular treatment of subjects with infrarenal abdominal aortic or
aortoiliac aneurysms.
Study design
The Endurant Evo International Clinical Trial is a prospective, multi-center,
pre-market, non-randomized, single-arm trial.
Intervention
Since the patient would have been treated with an AAA stent graft anyway, the
intervention in this study is the use of the Endurant Evo stent graft, a fourth
generation stent graft on the Endurant product platform of Medtronic.
Study burden and risks
Appendix L.3 of the CIP shows a list of potential adverse events that may be
associated with use of the Endurant Evo AAA stent graft system. The occurrence
of the listed complications may lead to a repeat endovascular intervention
and/or open surgical repair. Since the Endurant Evo AAA stent graft system is
an investigational device, all risks may not be known. However, they are
believed to be similar to those associated with the existing endovascular
devices in clinical use or commercially available, as well as the risks
associated with standard open surgical repair of AAA. All efforts will be made
to minimize these risks by selecting investigators who are experienced and
skilled in using endovascular aortic devices and who have been adequately
trained. Also, risk mitigation activities were performed during development
and design verification tests of the device.
Other procedures within this study are part of the standard of care procedures
associated with EVAR, except for the EQ-5D questionnaire which has to be
completed by the subjects during the screening and FU visits.
Endepolsdomein 5
Maastricht 6229GW
NL
Endepolsdomein 5
Maastricht 6229GW
NL
Listed location countries
Age
Inclusion criteria
- 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
Exclusion criteria
- 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52139.078.15 |