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

NCT00646048 | Completed Phase 1 Results

• 1 other identifier: S2106
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 7

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal Aortic Aneurysm; AAA; TriVascular Stent-Graft System; Stent-Graft

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Number of Participants Who Achieve Technical Success of the Stent Graft System.

  Post procedure

Study Arms (1)

Arm 1

EXPERIMENTAL

This arm is for patient that receive the TriVascular Stent-Graft System.

Device: TriVascular Stent-Graft System

Interventions

TriVascular Stent-Graft System DEVICE

TriVascular Stent-Graft System

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (7)

Harbor UCLA Medical Center

Torrance, California, 90509, United States

Location

Georgetown University Pasquerilla Healthcare

Washington D.C., District of Columbia, 20007, United States

Location

University of Florida - Shands Hospital

Gainesville, Florida, 32610, United States

Location

Miami Cardiac & Vascular Institute Baptist Hospital

Miami, Florida, 33176, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Colleen Holthe, Clinical Project Manager
• Organization: Boston Scientific

Colleen.Holthe@bsci.com

651-581-4632

Study Officials

• Pamela Grady, PhD

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: March 28, 2008
• Study Start: February 1, 2003
• Primary Completion: November 1, 2004
• Study Completion: March 1, 2010
• Last Updated: January 28, 2011
• Results First Posted: January 19, 2011

Record last verified: 2011-01

Locations

US (7)