Trial record 10 of 144 for:
"Abdominal aortic aneurysm"
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:
Boston Scientific Corporation
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00646048
First received: March 26, 2008
Last updated: January 26, 2011
Last verified: January 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Abdominal Aortic Aneurysm |
Device: TriVascular Stent-Graft System |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms |
Resource links provided by NLM:
Further study details as provided by Boston Scientific Corporation:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 43 |
| Study Start Date: | February 2003 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
This arm is for patient that receive the TriVascular Stent-Graft System.
|
Device: TriVascular Stent-Graft System
TriVascular Stent-Graft System
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00646048
Locations
| United States, California | |
| Harbor UCLA Medical Center | |
| Torrance, California, United States, 90509 | |
| United States, District of Columbia | |
| Georgetown University Pasquerilla Healthcare | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| University of Florida - Shands Hospital | |
| Gainesville, Florida, United States, 32610 | |
| Miami Cardiac & Vascular Institute Baptist Hospital | |
| Miami, Florida, United States, 33176 | |
| United States, New York | |
| Albany Medical College | |
| Albany, New York, United States, 12208 | |
| United States, Pennsylvania | |
| University of Pennsylvania Medical Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| University of Pittsburgh Shadyside Hospital | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
| Study Director: | Pamela Grady, PhD | Boston Scientific Corporation |
More Information
No publications provided
| Responsible Party: | Colleen Holthe, Boston Scientific |
| ClinicalTrials.gov Identifier: | NCT00646048 History of Changes |
| Other Study ID Numbers: | S2106 |
| Study First Received: | March 26, 2008 |
| Results First Received: | June 29, 2010 |
| Last Updated: | January 26, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Boston Scientific Corporation:
|
Abdominal Aortic Aneurysm AAA TriVascular Stent-Graft System Stent-Graft |
Additional relevant MeSH terms:
|
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013