search
Back to results

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

Primary Purpose

Abdominal Aortic Aneurysm

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TriVascular Stent-Graft System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm focused on measuring Abdominal Aortic Aneurysm, AAA, TriVascular Stent-Graft System, Stent-Graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Harbor UCLA Medical Center
  • Georgetown University Pasquerilla Healthcare
  • University of Florida - Shands Hospital
  • Miami Cardiac & Vascular Institute Baptist Hospital
  • Albany Medical College
  • University of Pennsylvania Medical Center
  • University of Pittsburgh Shadyside Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
March 26, 2008
Last Updated
January 26, 2011
Sponsor
Boston Scientific Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT00646048
Brief Title
A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms
Acronym
AAA IDE
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

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
Keywords
Abdominal Aortic Aneurysm, AAA, TriVascular Stent-Graft System, Stent-Graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
This arm is for patient that receive the TriVascular Stent-Graft System.
Intervention Type
Device
Intervention Name(s)
TriVascular Stent-Graft System
Intervention Description
TriVascular Stent-Graft System
Primary Outcome Measure Information:
Title
Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure.
Description
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.
Time Frame
1 month
Title
Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT).
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Number of Participants Who Achieve Technical Success of the Stent Graft System.
Description
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.
Time Frame
Post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Grady, PhD
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Harbor UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Georgetown University Pasquerilla Healthcare
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Florida - Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Miami Cardiac & Vascular Institute Baptist Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Shadyside Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs