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Status unknownNCT01033214Updated May 20, 2015

ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial

A Phase 1 interventional study of Endovascular repair of TAA in the descending Thoracic Aorta in Thoracic Aortic Aneurysm, sponsored by Duke Vascular, Inc.. Status unknown at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-20.

Sponsored by Duke Vascular, Inc. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Thoracic Aortic Aneurysm

Keywords

  • TAA
  • Thoracic
  • Descending Thoracic Aorta
  • TAArget
03

In context

Aortic Dissection

386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.

This study's planned enrollment of 30 is below the median of 84 across 198 interventional studies indexed under Aortic Dissection.

Browse Aortic Dissection studies →

Lead sponsor

Duke Vascular, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    TAArget Thoracic Stent Graft

    those treated with the investigational device

    Device: Endovascular repair of TAA in the descending Thoracic Aorta

Interventions

  • DeviceEndovascular repair of TAA in the descending Thoracic Aorta

    Usage of the TAArget thoracic stent graft for treatment of TAA in the Descending Thoracic Aorta.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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 outcomes

  1. • 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

07

Study locations

2 sites
  • Christiana Hospital
    Newark, Delaware 19713, United States
  • Emory University School of Medicine
    Atlanta, Georgia 30322, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01033214
Lead sponsor
Duke Vascular, Inc.
Responsible party
Sponsor
First posted
Dec 16, 2009
Start date
Jan 2010
Primary completion
Jun 2011
Completion
Dec 2015 (estimated)
Last update
May 20, 2015

Study contacts

Kartikeshwar Kasirajan, M.D.
principal investigator · Emory University Medical School

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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