ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial

Thoracic Aortic Aneurysm 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01033214
• Other study ID #: LMV-TAA-P1-001
• Status: Active, not recruiting
• Phase: Phase 1
• First received: December 14, 2009
• Last updated: May 18, 2015
• Start date: January 2010
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: Duke Vascular, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Evaluate the safety and effectiveness of endovascular repair with the LeMaitre TAArget thoracic stent graft as an alternative to open surgical repair.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Thoracic Aortic Aneurysm

Intervention

Device:
• Endovascular repair of TAA in the descending Thoracic Aorta
Usage of the TAArget thoracic stent graft for treatment of TAA in the Descending Thoracic Aorta.

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Christiana Hospital	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Duke Vascular, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		30 day and 6 month	Yes
Primary	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		30 day and 6 months	No
Secondary	• All cause mortality • Aneurysm related mortality compared to an open surgical control group • Major adverse events • Minor adverse events		30 day and 6 month	Yes