ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial

NCT01033214 | Unknown Phase 1

• 1 other identifier: LMV-TAA-P1-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Thoracic Aortic Aneurysm

Keywords

TAA; Thoracic; Descending Thoracic Aorta; TAArget

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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

  30 day and 6 month

Study Arms (1)

TAArget Thoracic Stent Graft

EXPERIMENTAL

those treated with the investigational device

Device: Endovascular repair of TAA in the descending Thoracic Aorta

Interventions

Endovascular repair of TAA in the descending Thoracic Aorta DEVICE

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

TAArget Thoracic Stent Graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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 (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke Vascular, Inc.: lead

Study Sites (2)

Christiana Hospital

Newark, Delaware, 19713, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Kartikeshwar Kasirajan, M.D.

  Emory University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2009
• First Posted: December 16, 2009
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2015
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

US (2)