Phase 1
N=43
A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT00646048 ↗Enrolled (actual)
43
Serious AEs
81.4%
Results posted
Jan 2011
Primary outcome: Primary: Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure. — 36 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- TriVascular Stent-Graft System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Nov 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure. |
36 | — |
| PRIMARY Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT). |
— | — |
| SECONDARY Number of Participants Who Achieve Technical Success of the Stent Graft System. |
42 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00646048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.