N/A
N=49
Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With Abdominal Aortic Aneurysms (AAA)
Abdominal Aortic Aneurysms
Bottom Line
View on ClinicalTrials.gov: NCT00695253 ↗Enrolled (actual)
49
Serious AEs
59.2%
Results posted
Sep 2021
Primary outcome: Primary: Number of Participants With Successful Exclusion of Abdominal Aortic Aneurysm — 49 participants' AAA
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Talent Endoluminal Spring Graft System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rodney A. White, M.D.
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Exclusion of Abdominal Aortic Aneurysm |
49 | — |
| SECONDARY Number of Participants With Successful Device Delivery and Deployment |
49 | — |
Summary
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.
Eligibility Criteria
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 9 cm from the aortic bifurcation.
- Subject has proximal and distal iliac neck diameters > 8 mm and 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.
Data sourced from ClinicalTrials.gov (NCT00695253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.