Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With Abdominal Aortic Aneurysms (AAA)

NCT00695253 | Completed Results DMC

• 1 other identifier: 10807-01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysms

Keywords

AAA

Outcome Measures

Primary Outcomes (1)

• 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).

  From the date of treatment assessed up to 5 years post treatment.

Secondary Outcomes (1)

• Number of Participants With Successful Device Delivery and Deployment

  From the date of treatment assessed up to 5 years post treatment.

Study Arms (1)

Talent Endoluminal Spring Graft System

OTHER

Single Arm study of the endoluminal treatment of Abdominal Aortic Aneurysms using the Talent Endoluminal Spring Graft System

Device: Talent Endoluminal Spring Graft System

Interventions

Talent Endoluminal Spring Graft System DEVICE

Endovascular repair for patients with AAA who meet the inclusion criteria for the study

Talent Endoluminal Spring Graft System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rodney A. White, M.D.: lead

Study Sites (1)

LAC Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Rodney A. White, M. D.
• Organization: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

rawhite@ucla.edu

310 963-5230

Study Officials

• Rodney A. White, M.D.

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Vascular Surgery

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: June 11, 2008
• Study Start: April 1, 2002
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 15, 2023
• Results First Posted: September 29, 2021

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)