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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rodney A. White, M.D., Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT00695253
First received: December 28, 2007
Last updated: March 1, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention
Abdominal Aortic Aneurysms
Device: Endoluminal treatment of abdominal aortic aneurysms using the Medtronic/Talent Stent Graft

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With AAA

Resource links provided by NLM:


Further study details as provided by Los Angeles Biomedical Research Institute:

Primary Outcome Measures:
  • The objective of this study is to evaluate the safety and effectiveness of the Medtronic/Talent bifurcated Stent-Graft System. [ Time Frame: open ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the safety of the device as indicated by the adverse event rates and to determine the effectiveness of the device as indicated by aneurysm exclusion and hemodynamic patency. [ Time Frame: open ] [ Designated as safety issue: Yes ]

Enrollment: 49
Study Start Date: January 2002
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Device: Endoluminal treatment of abdominal aortic aneurysms using the Medtronic/Talent Stent Graft
Stent-graft for AAA
Other Name: Medtronic/Talent

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695253

Locations
United States, California
LAC Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Sponsors and Collaborators
Rodney A. White, M.D.
Investigators
Principal Investigator: Rodney A. White, M.D. Los Angeles Biomedical Research Institute
  More Information

Responsible Party: Rodney A. White, M.D., Chief, Vascular Surgery, Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT00695253     History of Changes
Other Study ID Numbers: 10807-01 
Study First Received: December 28, 2007
Last Updated: March 1, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Los Angeles Biomedical Research Institute:
AAA

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on December 09, 2016