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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

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:

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.

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

NCT ID

NCT01033214

First Posted

December 14, 2009

Last Updated

May 18, 2015

Sponsor

Duke Vascular, Inc.

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

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

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

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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