ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial

Phase 1

• Conditions: Thoracic Aortic Aneurysm
• Interventions: Device: Endovascular repair of TAA in the descending Thoracic Aorta

• Registration Number: NCT01033214
• Lead Sponsor: Duke Vascular, Inc.

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.

Study Timeline

• Study First Submitted: 2009-12-14
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-16
• Study Start: 2010-01
• Primary Completion: 2011-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-18
• Last Update Posted: 2015-05-20
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAArget Thoracic Stent Graft	Endovascular repair of TAA in the descending Thoracic Aorta	those treated with the investigational device

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
• All cause mortality • Aneurysm related mortality compared to an open surgical control group • Major adverse events • Minor adverse events	30 day and 6 month

Trial Locations

Locations (2)

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Christiana Hospital; 🇺🇸 Newark, Delaware, United States