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ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Duke Vascular, Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01033214
First Posted: December 16, 2009
Last Update Posted: May 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke Vascular, Inc.
  Purpose
Evaluate the safety and effectiveness of endovascular repair with the LeMaitre TAArget thoracic stent graft as an alternative to open surgical repair.

Condition Intervention Phase
Thoracic Aortic Aneurysm Device: Endovascular repair of TAA in the descending Thoracic Aorta Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Feasibility Study of the TAArget Thoracic Stent Graft for the Treatment of Aneurysms in the Descending Thoracic Aorta

Resource links provided by NLM:


Further study details as provided by Duke Vascular, Inc.:

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. [ Time Frame: 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 [ Time Frame: 30 day and 6 months ]

Secondary Outcome Measures:
  • • 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 ]

Estimated Enrollment: 30
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033214


Locations
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19713
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Duke Vascular, Inc.
Investigators
Principal Investigator: Kartikeshwar Kasirajan, M.D. Emory University Medical School
  More Information

Responsible Party: Duke Vascular, Inc.
ClinicalTrials.gov Identifier: NCT01033214     History of Changes
Other Study ID Numbers: LMV-TAA-P1-001
First Submitted: December 14, 2009
First Posted: December 16, 2009
Last Update Posted: May 20, 2015
Last Verified: May 2015

Keywords provided by Duke Vascular, Inc.:
TAA
Thoracic
Descending Thoracic Aorta
TAArget

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases