A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms (AAA IDE)

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00646048
First received: March 26, 2008
Last updated: January 26, 2011
Last verified: January 2011
  Purpose

This study was a prospective observational study examined the safety of the TriVascular AAA Stent-Graft System in the elective treatment of patients with abdominal aortic aneurysms. Specifically, the study will evaluate the safety of the TriVascualr AAA Stent-Graft System, evaluate the ability to deliver the Tri-Vascular AAA Stent-Graft System to the desired location within the aorta, and evaluate the ability of the TriVascular AAA Stent-Graft to exclude the abdominal aortic aneurysm.


Condition Intervention Phase
Abdominal Aortic Aneurysm
Device: TriVascular Stent-Graft System
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Device related adverse events included, but were not limited to: Stent Graft Migration, Vessel dissection or perforation, stent graft occlusion, branch vessel occlusion, aneurysm rupture.

  • Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT). [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    A Type I endoleak is a persistent perigraft channel of blood flow that develops due to inadequate or ineffective seal at the graft ends (attachment zones). A Type III endoleak occurs in the midgraft region due to leakage through a defect in the graft fabric or between the segments of a multisegmental graft. A Type IV endoleak is seen on completion of angiography or subsequent contrast studies as any blush of contrast that is presumed to emanate from blood diffusion across the porous graft fabric or through small holes in the graft cause by sutures or stent struts.


Secondary Outcome Measures:
  • Number of Participants Who Achieve Technical Success of the Stent Graft System. [ Time Frame: Post procedure ] [ Designated as safety issue: Yes ]
    Technical success was defined as successful introduction of the delivery catheter into the arterial system at the time of the study procedure and successful delivery/deployment of the stent graft system to the intended location with the absence of device related surgical conversion and intra-operative mortality. Device related surgical conversion is defined as the inability to deliver or deploy the stent graft system, then subsequently surgically treating the patient.


Enrollment: 43
Study Start Date: February 2003
Study Completion Date: March 2010
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
This arm is for patient that receive the TriVascular Stent-Graft System.
Device: TriVascular Stent-Graft System
TriVascular Stent-Graft System

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or infertile female
  • Have signed an informed consent form.
  • Are considered an appropriate candidate for open surgical repair of an abdominal aortic aneurysm.
  • at least one of the following: Abdominal aortic aneurysm >= 4.5 cm in diameter; aneurysm has increased in size by 0.5cm in last 6 months; maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment; saccular aneurysm larger than 3 cm.
  • Have patent iliac or femoral arteries that allow endovascular access to the aneurysmal site with a 17F Delivery Catheter.

Exclusion Criteria:

  • A dissecting, acutely ruptured, or leaking aneurysm, or an acute vascular injury due to trauma.
  • A need for emergent surgery.
  • contraindication to undergoing angiography.
  • A Thoracic aortic aneurysm that requires treatment.
  • Presence of thrombus or atheroma in proximal aortic neck covering > 50% of the endoluminal surface.
  • Presence of diffuse atherosclerotic disease in either common iliac artery that reduces the iliac artery diameter to <7mm.
  • Congenital abnormalities in which the placement of the stent-graft will cause occlusion of major arterial flow. Such abnormalities should be evaluated(e.g. angiography or CT) prior to treatment.
  • Unstable angina
  • Morbid obesity or other clinical conditions that severely inhibit x-ray visualization of the aorta.
  • Connective tissue disease (e.g., Marfan's or Ehlers-Danlos syndrome.)
  • Hypercoagulable state.
  • Contraindication for anticoagulation.
  • Acute renal failure.
  • Active systemic infection.
  • less than 18 years of age.
  • Life expectancy less than 1 year.
  • Current, or anticipated participation within 1 year, in another research study involving an investigational device or new drug (with the exception of participation in the Lifeline Registry of Endovascular Therapy).
  • Other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
  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: NCT00646048

Locations
United States, California
Harbor UCLA Medical Center
Torrance, California, United States, 90509
United States, District of Columbia
Georgetown University Pasquerilla Healthcare
Washington, District of Columbia, United States, 20007
United States, Florida
University of Florida - Shands Hospital
Gainesville, Florida, United States, 32610
Miami Cardiac & Vascular Institute Baptist Hospital
Miami, Florida, United States, 33176
United States, New York
Albany Medical College
Albany, New York, United States, 12208
United States, Pennsylvania
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Pamela Grady, PhD Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Colleen Holthe, Boston Scientific
ClinicalTrials.gov Identifier: NCT00646048     History of Changes
Other Study ID Numbers: S2106
Study First Received: March 26, 2008
Results First Received: June 29, 2010
Last Updated: January 26, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
Abdominal Aortic Aneurysm
AAA
TriVascular Stent-Graft System
Stent-Graft

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

ClinicalTrials.gov processed this record on July 31, 2014