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

Abdominal Aortic Aneurysm Clinical Trial

— AAA IDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646048
• Other study ID #: S2106
• Status: Completed
• Phase: Phase 1
• First received: March 26, 2008
• Last updated: January 26, 2011
• Start date: February 2003
• Est. completion date: March 2010

Study information

• Verified date: January 2011
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 2010
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• TriVascular Stent-Graft System
TriVascular Stent-Graft System

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	University of Florida - Shands Hospital	Gainesville	Florida
United States	Miami Cardiac & Vascular Institute Baptist Hospital	Miami	Florida
United States	University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	University of Pittsburgh Shadyside Hospital	Pittsburgh	Pennsylvania
United States	Harbor UCLA Medical Center	Torrance	California
United States	Georgetown University Pasquerilla Healthcare	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure.	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.	1 month	Yes
Primary	Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT).	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.	1 month	Yes
Secondary	Number of Participants Who Achieve Technical Success of the Stent Graft System.	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.	Post procedure	Yes