Clinical trial NCT00646048: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Abdominal Aortic Aneurysm
Keywords: Abdominal Aortic Aneurysm
AAA
TriVascular Stent-Graft System
Stent-Graft
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure.
timeFrame: 1 month
measure: Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT).
timeFrame: 1 month
Secondary outcomes:
measure: Number of Participants Who Achieve Technical Success of the Stent Graft System.
timeFrame: Post procedure
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Harbor UCLA Medical Center
state: California
city: Washington
country: United States
facility: Georgetown University Pasquerilla Healthcare
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida - Shands Hospital
state: Florida
city: Miami
country: United States
facility: Miami Cardiac & Vascular Institute Baptist Hospital
state: Florida
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Shadyside Hospital
state: Pennsylvania
Study officials:
affiliation: Boston Scientific Corporation
name: Pamela Grady, PhD
role: STUDY_DIRECTOR
References: