GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta

NCT00608829 | Completed Phase 2 Results

• 1 other identifier: TAG 06-02
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in subjects with aneurysms of the descending thoracic aorta.

Conditions

Aortic Aneurysm, Thoracic

Outcome Measures

Primary Outcomes (1)

• Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment

  Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (\>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149).

  one year

Study Arms (1)

GORE TAG® Thoracic Endoprosthesis

EXPERIMENTAL

Gore 45mm TAG Thoracic Endograft Implantation

Device: GORE TAG® Thoracic Endoprosthesis

Interventions

GORE TAG® Thoracic Endoprosthesis DEVICE

Implant

Also known as: GORE TAG® Thoracic Endoprosthesis - 45 mm

GORE TAG® Thoracic Endoprosthesis

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of Descending thoracic aortic aneurysm deemed to warrant surgical repair
• Fusiform (≥50 mm), or
• Saccular (no diameter criteria)
• All proximal and/or all distal landing zone inner diameters between 37-42 mm
• Diameter taper between proximal and distal landing zones and the ability to use devices of different diameters to compensate for the taper must be within device sizing guide specifications
• Proximal and distal landing zone length greater than 2.0 cm
• Landing zone must not be aneurysmal, dissected, heavily calcified, or heavily thrombosed
• Life expectancy \> 2 years
• Subject is open surgical candidate defined as:
• Able to tolerate thoracotomy
• American Society of Anesthesiologists class I-IV (class V excluded)
• New York Heart Association class I-III or not applicable (class IV excluded)
• Male or infertile female
• Age greater than 21 years
• Able to comply with study protocol requirements, including follow-up

You may not qualify if:

• Mycotic aneurysm
• Hemodynamically unstable aneurysm rupture
• Aortic dissection
• Planned occlusion of left carotid or celiac arteries
• Planned concomitant surgical procedure (other than left subclavian transposition), or major surgery within 30 days of treatment date
• Myocardial infarction or stroke within 6 weeks of treatment
• Pre-treatment creatinine \> 2.0 mg/dL
• Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
• Participation in another drug or device study within 1 year of treatment
• History of drug abuse within 6 months of treatment

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Enrollment into this trial was completed prematurely with 23 enrolled subjects. The 45mm TAG Device was approved based on the data collected and a descriptive statistical analysis. Follow up of enrolled subjects continued for 5 years.

Results Point of Contact

• Title: Abe Letter
• Organization: W.L. Gore and Associates

aletter@wlgore.com

928 864 3113

Study Officials

• Michel Makaroun, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: February 6, 2008
• Study Start: February 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2014
• Last Updated: March 5, 2015
• Results First Posted: September 15, 2010

Record last verified: 2015-03

Locations

US (1)