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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysms
• Intervention / Treatment: Device: Talent Endoluminal Spring Graft System

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90502
      • LAC Harbor-UCLA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Talent Endoluminal Spring Graft System; Single Arm study of the endoluminal treatment of Abdominal Aortic Aneurysms using the Talent Endoluminal Spring Graft System	Device: Talent Endoluminal Spring Graft System; Endovascular repair for patients with AAA who meet the inclusion criteria for the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the date of treatment assessed up to 5 years post treatment.

Collaborators and Investigators

• Sponsor: Rodney A. White, M.D.

Study record dates

Study Major Dates

• Study Start: April 1, 2002
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: December 28, 2007
• First Submitted That Met QC Criteria: June 10, 2008
• First Posted (Estimate): June 11, 2008

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: AAA
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 10807-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO