Clinical trial NCT01033214: ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial
Official title: A Phase I Feasibility Study of the TAArget Thoracic Stent Graft for the Treatment of Aneurysms in the Descending Thoracic Aorta
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Thoracic Aortic Aneurysm
Keywords: TAA
Thoracic
Descending Thoracic Aorta
TAArget
Lead sponsor: Duke Vascular, Inc.
Sponsor class: INDUSTRY
First posted: 2009-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: 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.
timeFrame: 30 day and 6 month
measure: 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
timeFrame: 30 day and 6 months
Secondary outcomes:
measure: • All cause mortality • Aneurysm related mortality compared to an open surgical control group • Major adverse events • Minor adverse events
timeFrame: 30 day and 6 month
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
Study officials:
affiliation: Emory University Medical School
name: Kartikeshwar Kasirajan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: