ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
LeMaitre Vascular
ClinicalTrials.gov Identifier:
NCT01033214
First received: December 14, 2009
Last updated: December 1, 2010
Last verified: December 2010
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 LeMaitre Vascular:

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2012 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
LeMaitre Vascular
Investigators
Principal Investigator: Kartikeshwar Kasirajan, M.D. Emory University Medical School
  More Information

No publications provided

Responsible Party: Andrew Hodgkinson/Vice President, Clinical and Regulatory Affairs, LeMaitre Vascular
ClinicalTrials.gov Identifier: NCT01033214     History of Changes
Other Study ID Numbers: LMV-TAA-P1-001
Study First Received: December 14, 2009
Last Updated: December 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by LeMaitre Vascular:
TAA
Thoracic
Descending Thoracic Aorta
TAArget

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

ClinicalTrials.gov processed this record on July 28, 2014