Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With Abdominal Aortic Aneurysms (AAA)
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | January 2002 |
| End Date: | March 2013 |
Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With AAA
The purpose of this study is to evaluate the safety and effectiveness of the Talent
Endoluminal Spring Graft System, an investigational device, to treat abdominal aortic
aneurysms (AAA). The treatment population will include patients with an abdominal aortic
aneurysm who meet the inclusion/exclusion criteria. All patients in the treatment population
will undergo post-procedure follow-up evaluations at one (1), six (6), and 12 months and
annually thereafter up to five (5) years post-procedure.
Endoluminal Spring Graft System, an investigational device, to treat abdominal aortic
aneurysms (AAA). The treatment population will include patients with an abdominal aortic
aneurysm who meet the inclusion/exclusion criteria. All patients in the treatment population
will undergo post-procedure follow-up evaluations at one (1), six (6), and 12 months and
annually thereafter up to five (5) years post-procedure.
Endovascular aneurysm repair (EVAR) offers certain advantages as compared to surgical repair
of an abdominal aortic aneurysm. Known benefits associated with EVAR, as described in
scientific literature, include minimally invasive procedure, shorter ICU and hospital stay,
reduced blood loss, more rapid recovery, and reduced need for general anesthesia. Potential
benefits that may be associated with use of the Talent device include reduced occurrence of
endoleaks, therefore reduced subsequent re-interventions. The risks/complications known to
occur to all patients undergoing AAA repair may include anesthetic complications, (e.g.,
aspiration), aneurysm enlargement, rupture, perforation or dissection, bleeding, arterial or
venous thrombosis and/or pseudoaneurysm, arteriovenous fistula, hematoma or coagulopathy,
bowel complications, cardiac complications, (e.g., arrhythmia, myocardial infarction,
congestive heart failure, hypotension, hypertension), embolization (micro and macro) with
transient or permanent ischemia or infarction, genitourinary complications, infection,
neurologic complications, occlusion of device or native vessel, pulmonary/respiratory
complications and renal complications.
of an abdominal aortic aneurysm. Known benefits associated with EVAR, as described in
scientific literature, include minimally invasive procedure, shorter ICU and hospital stay,
reduced blood loss, more rapid recovery, and reduced need for general anesthesia. Potential
benefits that may be associated with use of the Talent device include reduced occurrence of
endoleaks, therefore reduced subsequent re-interventions. The risks/complications known to
occur to all patients undergoing AAA repair may include anesthetic complications, (e.g.,
aspiration), aneurysm enlargement, rupture, perforation or dissection, bleeding, arterial or
venous thrombosis and/or pseudoaneurysm, arteriovenous fistula, hematoma or coagulopathy,
bowel complications, cardiac complications, (e.g., arrhythmia, myocardial infarction,
congestive heart failure, hypotension, hypertension), embolization (micro and macro) with
transient or permanent ischemia or infarction, genitourinary complications, infection,
neurologic complications, occlusion of device or native vessel, pulmonary/respiratory
complications and renal complications.
Inclusion Criteria:
- Subjects who participate in this study must fulfill all of the following criteria.
- Subject is > 18 years of age.
- Subject is not pregnant, and, if female and of child-bearing potential, is practicing
contraception.
- Subject has documented evidence of at least one patent internal iliac artery.
- Subject has an AAA that is dilated to > 4 cm in diameter.
- 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 <60o.
- Subject has renal arteries > 9 cm from the aortic bifurcation.
- Subject has proximal and distal iliac neck diameters > 8 mm and < 18 mm to accommodate
stock devices. For those subjects whose proximal and distal iliac diameters are > 18
mm, custom devices with a variation in fixation diameters will be ordered from the
manufacturer.
- Subject has a distal iliac neck length > 15 mm.
- Subject has signed informed consent.
- Subject will be available for follow-up for 12 months after the procedure.
Exclusion Criteria:
- Subjects who fulfill any of the following criteria may not participate in this study.
- Subject has patent internal iliac arteries that require graft extension to the
external iliac arteries.
- Subject has one or more patent subrenal arteries with potential retrograde flow after
stent-grafting.
- Subject has a dominant patent inferior mesenteric artery and an occluded or stenotic
celiac and superior mesenteric artery.
- Subject has an aneurysm involving both internal iliac arteries.
- 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 contraindications for use of contrast medium or anticoagulation drugs.
- Subject has received a previous stent in the subrenal aorta.
- Subject has an untreatable bleeding diathesis.
- Subject is in a hypercoagulable state.
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