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

March 26, 2008
January 26, 2011
February 2003
November 2004   (final data collection date for primary outcome measure)
  • 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.
  • Absence of device related adverse events within 1 month of the endovascular procedure [ Time Frame: 1 month, 6 months, 1 year, annually through 5 year follow up ] [ Designated as safety issue: Yes ]
  • Absence of Types I, II, and IV endoleaks at 1 month follow-up [ Time Frame: 1 month, 6 months, 1 year, annually through 5 year follow up ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00646048 on ClinicalTrials.gov Archive Site
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.
  • Success in introduction of the delivery catheter into the arterial system [ Time Frame: Post procedure ] [ Designated as safety issue: Yes ]
  • Deployment of the stent-graft in the desired location in the absence of device-related surgical conversion and intra-operative mortality. [ Time Frame: Post procedure ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms
A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Abdominal Aortic Aneurysm
Device: TriVascular Stent-Graft System
TriVascular Stent-Graft System
Experimental: Arm 1
This arm is for patient that receive the TriVascular Stent-Graft System.
Intervention: Device: TriVascular Stent-Graft System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
March 2010
November 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00646048
S2106
No
Colleen Holthe, Boston Scientific
Boston Scientific Corporation
Not Provided
Study Director: Pamela Grady, PhD Boston Scientific Corporation
Boston Scientific Corporation
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP