Overview

This trial is active, not recruiting.

Condition thoracic aortic aneurysm
Treatment endovascular repair of taa in the descending thoracic aorta
Phase phase 1
Sponsor Duke Vascular, Inc.
Start date January 2010
End date June 2011
Trial size 30 participants
Trial identifier NCT01033214, LMV-TAA-P1-001

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
those treated with the investigational 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.

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.
time frame: 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
time frame: 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
time frame: 30 day and 6 month

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Phase I Feasibility Study of the TAArget Thoracic Stent Graft for the Treatment of Aneurysms in the Descending Thoracic Aorta
Principal investigator Kartikeshwar Kasirajan, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Duke Vascular, Inc..