Back to resultsPhysician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With Abdominal Aortic Aneurysms (AAA)
Primary Purpose
Abdominal Aortic Aneurysms
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Talent Endoluminal Spring Graft System
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Aortic Aneurysms focused on measuring AAA
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 < 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.
Sites / Locations
- LAC Harbor-UCLA Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Talent Endoluminal Spring Graft System
Arm Description
Single Arm study of the endoluminal treatment of Abdominal Aortic Aneurysms using the Talent Endoluminal Spring Graft System
Outcomes
Primary Outcome Measures
Number of Participants With Successful Exclusion of Abdominal Aortic Aneurysm
The safety and effectiveness of the endoluminal device was determined by the number participants with successful exclusion of the abdominal aortic aneurysm (AAA).
Secondary Outcome Measures
Number of Participants With Successful Device Delivery and Deployment
Delivery success is defined as the successful access of the vessel and insertion of the delivery sheath to the treatment site. Deployment success is defined as the advancement through the vasculature to the desired location and full deployment within 0.5 cm of the intended location. Aneurysm exclusion is achieved when there is no evidence of blood flow around or through the stent graft into the aneurysm or where there is an absence of contrast within the aneurysm sac.
Full Information
NCT ID
NCT00695253
First Posted
December 28, 2007
Last Updated
February 14, 2023
Sponsor
Rodney A. White, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT00695253
Brief Title
Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With Abdominal Aortic Aneurysms (AAA)
Official Title
Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With AAA
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rodney A. White, M.D.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysms
Keywords
AAA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Talent Endoluminal Spring Graft System
Arm Type
Other
Arm Description
Single Arm study of the endoluminal treatment of Abdominal Aortic Aneurysms using the Talent Endoluminal Spring Graft System
Intervention Type
Device
Intervention Name(s)
Talent Endoluminal Spring Graft System
Intervention Description
Endovascular repair for patients with AAA who meet the inclusion criteria for the study
Primary Outcome Measure Information:
Title
Number of Participants With Successful Exclusion of Abdominal Aortic Aneurysm
Description
The safety and effectiveness of the endoluminal device was determined by the number participants with successful exclusion of the abdominal aortic aneurysm (AAA).
Time Frame
From the date of treatment assessed up to 5 years post treatment.
Secondary Outcome Measure Information:
Title
Number of Participants With Successful Device Delivery and Deployment
Description
Delivery success is defined as the successful access of the vessel and insertion of the delivery sheath to the treatment site. Deployment success is defined as the advancement through the vasculature to the desired location and full deployment within 0.5 cm of the intended location. Aneurysm exclusion is achieved when there is no evidence of blood flow around or through the stent graft into the aneurysm or where there is an absence of contrast within the aneurysm sac.
Time Frame
From the date of treatment assessed up to 5 years post treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 < 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodney A. White, M.D.
Organizational Affiliation
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
LAC Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With Abdominal Aortic Aneurysms (AAA)
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