ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial

A Phase I Feasibility Study of the TAArget Thoracic Stent Graft for the Treatment of Aneurysms in the Descending Thoracic Aorta

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

Study Overview

• Status: Unknown
• Conditions: Thoracic Aortic Aneurysm
• Intervention / Treatment: Device: Endovascular repair of TAA in the descending Thoracic Aorta

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAArget Thoracic Stent Graft; those treated with the investigational device	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Duke Vascular, Inc.
• Investigators: Principal Investigator: Kartikeshwar Kasirajan, M.D., Emory University Medical School

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: December 14, 2009
• First Submitted That Met QC Criteria: December 15, 2009
• First Posted (Estimate): December 16, 2009

Study Record Updates

• Last Update Posted (Estimate): May 20, 2015
• Last Update Submitted That Met QC Criteria: May 18, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Thoracic; TAA; Descending Thoracic Aorta; TAArget
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aneurysm, Dissecting; Aortic Aneurysm; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: LMV-TAA-P1-001