Brief Title
Clinical Study of Abdominal Aortic Aneurysm Exclusion (TALENT Abdominal)
Official Title
Clinical Study of Abdominal Aortic Aneurysm Exclusion Using the TALENT Enhanced LPS Endoluminal Stent-Graft System
Brief Summary
The purpose of the study is to evaluate the TALENT endoluminal stent-graft system in patients
with abdominal aortic aneurysms. The TALENT endoluminal stent-graft system is a flexible,
implantable endoluminal vascular device preloaded in a placement system that is used to
exclude abdominal aortic aneurysms.
Detailed Description
An aneurysm is a localized dilatation of a blood vessel at least 1 1/2 to 2 times the normal
vessel diameter. Abdominal aortic aneurysms are relatively common, and have been detected in
1.3% to 2.7% of patients 65 to 80 years of age (Blum, et al, 1996; Collins, Araujo, and
Lindsell, 1988; Scott, Ashton, and Kay, 1991). A large proportion (up to 50%) of patients
with untreated AAAs experience rupture and exsanguination (Johansen, 1995). Ruptured AAAs are
the 13th leading cause of death in the US, accounting for more than 15,000 deaths per year
(Cronenwett and Sampson, 1995).
Conventional treatment of abdominal aortic aneurysms is by a surgical procedure involving
midline laparotomy, aortic clamping, aortic bypass, and blood loss with associated
transfusion. Improvements in surgical techniques and patient care have allowed the mortality
rate associated with this procedure to be reduced to approximately 5%, when elective repair
is done prior to rupture of the aneurysm. Risks of surgery increase when the patient is
considered to be a poor candidate for surgery.
Due to progress made in interventional radiology and endovascular surgery, it is now possible
to treat aneurysms without an abdominal surgical procedure, thus potentially further reducing
the risks associated with elective repair. This new therapeutic approach consists of
transfemoral introduction of a metallic stent coupled with a vascular graft. When the stent
device is deployed and expanded within the aneurysmal blood vessel, it creates a new aortic
lumen for blood flow, effectively excluding the aneurysm sac from the flow while maintaining
perfusion to the lower limbs. This less invasive technique is designed to prevent the need
for laparotomy, to reduce the need for blood transfusions, to decrease the use of anesthetics
and other drugs, and to speed recovery time.
The objective of this study is to evaluate the safety and effectiveness of the TALENT
endoluminal stent-graft system in patients who may be categorized as standard risk, high risk
or other indications. Standard risk patients are patients with indications for treatment that
are consistent with those for a manufacturer IDE, when there is no active enrollment in the
IDE. High risk patients are patients who do not meet the entrance criteria for the
manufacturer sponsored IDE as they are at high risk of morbidity and mortality with standard
surgical repair. Other indications would be considered patients with indications for
treatment outside of those or the manufacturer sponsored IDE.
This study will be performed in both high risk and low risk patients who are considered good
candidates for endoluminal repair of abdominal aortic aneurysms. Patients should be
heparinized during the implant procedure such that an activated clotting time of 300 seconds
is achieved. During implantation of the TALENT endoluminal stent-graft, the pre-implant CT
scan and available angiograms are used together with (on-the-table) digital subtraction
angiography (DSA), roadmapping, and angiography for proper implant positioning. The TALENT
endoluminal stent-graft endoprosthesis is inserted by delivery catheter and introducer sheath
via a surgical cutdown (e.g., external iliac artery, femoral artery) approach. The introducer
sheath and delivery catheter containing the stent-graft is inserted over a guidewire and
advanced into the aorta and above the aneurysm. With the delivery catheter in the correct
position, the push rod is held stationary while the outer sheath is slowly withdrawn. The
introducer sheath is then withdrawn further until the stent-graft is completely deployed. The
balloon may be inflated along the full length of the implanted device to model the springs
against the vessel wall and to unravel possible wrinkles in the graft fabric. After
deployment of the stent-graft, angiography is performed to verify implant position and to
check for the presence of endoleaks.
Subjects will undergo an evaluation of the TALENT endoluminal stent-graft to determine the
safety and efficacy of the device as indicated by the adverse event rate, and to determine
the risk factors that are most predictive of a successful outcome when used to exclude
abdominal aortic aneurysms that require suprarenal fixation in high risk and low risk
patients. Follow-up will be completed at 1, 6, 12, 24, 36, 48, and 60 months. Subject
evaluation at 1 month will include a complete Physical Examination, Bilateral ABIs, and a
Duplex Ultrasound (if not previously completed at time of discharge). Subject evaluation at 6
months will also include a Complete Physical Examination, Bilateral ABIs, Duplex Ultrasound,
and Abdominal X-ray (AP, Lateral, 2 Obliques). Subject evaluation at 12, 24, 36, 48, and 60
months will include a Complete Physical Examination, Bilateral ABIs, Abdominal X-ray (AP,
Lateral, 2 Obliques), and Spiral CT scan with and without IV Contrast 2.5mm.
Study Type
Interventional
Primary Outcome
Determine the proportion in whom successful implantation is achieved, as indicated by aneurysm exclusion and graft patency.
Secondary Outcome
Determine the proportion of patients who experience adverse events.
Condition
Abdominal Aortic Aneurysm
Intervention
TALENT Enhanced LPS Endoluminal Stent-Graft System
Study Arms / Comparison Groups
1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
75
Start Date
October 2002
Completion Date
October 2012
Primary Completion Date
October 2012
Eligibility Criteria
Inclusion Criteria:
- Subject is ≥ 18 years of age.
- Subject has a proximal AAA neck (distance between the top of the aneurysm and the
renal arteries) ≥ 5 mm.
- Subject has a proximal aortic neck diameter ≥ 14 mm and ≤ 32 mm.
- Subject has an angle between the suprarenal aorta and the aneurysm ≤ 60°.
- Subject has renal arteries ≥ 9 cm from the aortic neck bifurcation.
- Subject has proximal and distal iliac neck diameters ≥ 8 mm and ≤ 24 mm.
- Subject has a distal iliac neck length ≥ 15 mm.
- Subject has signed the informed consent.
- Subject will be available for follow-up at periodic intervals after the procedure.
Exclusion Criteria:
- Subject has a document patent inferior mesenteric artery and an occluded or stenotic
celiac and superior mesenteric artery.
- Subject has a lesion that cannot be crossed with a guide wire.
- Subject whose arterial access site cannot accommodate the delivery catheter.
- Subject has no distal vascular bed.
- Subject has systemic infection, or is suspected of having systemic infection.
- Subject has an untreatable bleeding diathesis.
- Subject is not available or is not willing to come back for periodic follow-up
(surveillance) after the procedure.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Edward B Diethrich, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00549432
Organization ID
G020149
Study Sponsor
Arizona Heart Institute
Study Sponsor
Edward B Diethrich, M.D., Principal Investigator, Arizona Heart Institute
Verification Date
May 2009