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ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial

Primary Purpose

Thoracic Aortic Aneurysm

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Endovascular repair of TAA in the descending Thoracic Aorta
Sponsored by
Duke Vascular, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Aortic Aneurysm focused on measuring TAA, Thoracic, Descending Thoracic Aorta, TAArget

Eligibility Criteria

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

Inclusion Criteria:

  • Subject is > 18 years of age. Female subjects are either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and have a negative serum pregnancy test at screening.

Subject is a candidate for endovascular thoracic aortic repair.

Subject has a TAA that meets one of the following criteria:

  1. Is diagnosed with a Fusiform Focal TAA ≥5cm, or
  2. Is diagnosed with a Fusiform Focal TAA that has a diameter ≤ 5 cm and has exhibited rapid expansion, or
  3. Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or
  4. Is diagnosed with a saccular TAA of any size (where potential for rupture is increased*).

    • Tortuosity and angulation do not exceed 90 degrees.
    • Subject has an arterial access site that allows for the introduction of the stent-graft delivery system.

Exclusion Criteria:

  • Subject has a life expectancy < 2 years.
  • Subject has a lesion that prevents safe delivery or expansion of the device.
  • Subject has concomitant ascending aortic aneurysm.
  • Subject has known allergies to any of the device materials.
  • Subject has coagulopathy or bleeding disorders that cannot be pre-treated.
  • Subject is contraindicated for contrast medium and anticoagulation drugs that cannot be pre-treated.

Sites / Locations

  • Christiana Hospital
  • Emory University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TAArget Thoracic Stent Graft

Arm Description

those treated with the investigational device

Outcomes

Primary Outcome Measures

Proportion of subjects who experience ≥ 1 major adverse events (MAE) related to the experimental device/procedure at early (30-day) and late (6-month) endovascular TAA repair as compared with the open surgical repair group.
The primary effectiveness endpoint of early (30-day) and late (6-month) endovascular TAA repair will be assessed by the proportion of subjects free from major device related events

Secondary Outcome Measures

• All cause mortality • Aneurysm related mortality compared to an open surgical control group • Major adverse events • Minor adverse events

Full Information

First Posted
December 14, 2009
Last Updated
May 18, 2015
Sponsor
Duke Vascular, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01033214
Brief Title
ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial
Official Title
A Phase I Feasibility Study of the TAArget Thoracic Stent Graft for the Treatment of Aneurysms in the Descending Thoracic Aorta
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke Vascular, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluate the safety and effectiveness of endovascular repair with the LeMaitre TAArget thoracic stent graft as an alternative to open surgical repair.
Detailed Description
Subject is > 18 years of age. Females subjects must be either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and must have a negative serum pregnancy test at screening. Subject is a candidate for endovascular thoracic aortic repair. Subject has a TAA that meets one of the following criteria: Is diagnosed with a Fusiform Focal TAA >5cm, or Is diagnosed with a Fusiform Focal TAA that has a diameter < 5 cm and has exhibited rapid expansion, or Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or Is diagnosed with a saccular TAA of any size.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Aortic Aneurysm
Keywords
TAA, Thoracic, Descending Thoracic Aorta, TAArget

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAArget Thoracic Stent Graft
Arm Type
Experimental
Arm Description
those treated with the investigational device
Intervention Type
Device
Intervention Name(s)
Endovascular repair of TAA in the descending Thoracic Aorta
Intervention Description
Usage of the TAArget thoracic stent graft for treatment of TAA in the Descending Thoracic Aorta.
Primary Outcome Measure Information:
Title
Proportion of subjects who experience ≥ 1 major adverse events (MAE) related to the experimental device/procedure at early (30-day) and late (6-month) endovascular TAA repair as compared with the open surgical repair group.
Time Frame
30 day and 6 month
Title
The primary effectiveness endpoint of early (30-day) and late (6-month) endovascular TAA repair will be assessed by the proportion of subjects free from major device related events
Time Frame
30 day and 6 months
Secondary Outcome Measure Information:
Title
• All cause mortality • Aneurysm related mortality compared to an open surgical control group • Major adverse events • Minor adverse events
Time Frame
30 day and 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is > 18 years of age. Female subjects are either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and have a negative serum pregnancy test at screening. Subject is a candidate for endovascular thoracic aortic repair. Subject has a TAA that meets one of the following criteria: Is diagnosed with a Fusiform Focal TAA ≥5cm, or Is diagnosed with a Fusiform Focal TAA that has a diameter ≤ 5 cm and has exhibited rapid expansion, or Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or Is diagnosed with a saccular TAA of any size (where potential for rupture is increased*). Tortuosity and angulation do not exceed 90 degrees. Subject has an arterial access site that allows for the introduction of the stent-graft delivery system. Exclusion Criteria: Subject has a life expectancy < 2 years. Subject has a lesion that prevents safe delivery or expansion of the device. Subject has concomitant ascending aortic aneurysm. Subject has known allergies to any of the device materials. Subject has coagulopathy or bleeding disorders that cannot be pre-treated. Subject is contraindicated for contrast medium and anticoagulation drugs that cannot be pre-treated.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kartikeshwar Kasirajan, M.D.
Organizational Affiliation
Emory University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

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ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial

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