Brief Title
A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms
Official Title
A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms
Brief 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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure.
Secondary Outcome
Number of Participants Who Achieve Technical Success of the Stent Graft System.
Condition
Abdominal Aortic Aneurysm
Intervention
TriVascular Stent-Graft System
Study Arms / Comparison Groups
Arm 1
Description: This arm is for patient that receive the TriVascular Stent-Graft System.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
43
Start Date
February 2003
Completion Date
March 2010
Primary Completion Date
November 2004
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pamela Grady, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00646048
Organization ID
S2106
Study Sponsor
Boston Scientific Corporation
Study Sponsor
Pamela Grady, PhD, Study Director, Boston Scientific Corporation
Verification Date
January 2011