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ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial

D

Duke Vascular

Status and phase

Unknown
Phase 1

Conditions

Thoracic Aortic Aneurysm

Treatments

Device: Endovascular repair of TAA in the descending Thoracic Aorta

Study type

Interventional

Funder types

Industry

Identifiers

NCT01033214
LMV-TAA-P1-001

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

TAArget Thoracic Stent Graft
Experimental group
Description:
those treated with the investigational device
Treatment:
Device: Endovascular repair of TAA in the descending Thoracic Aorta

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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