Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic

NCT00874250 | Completed Results DMC

• 1 other identifier: TAG 08-03
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the safety and efficacy of the GORE Conformable TAG® Thoracic Endoprosthesis in the primary treatment of aneurysm of the descending thoracic aorta (DTA) \> Primary Hypothesis: The proportion of subjects free from a major device event through 1 month post-treatment will not be significantly less than 0.95, which represents the proportion observed in previous clinical studies with the GORE TAG® Thoracic Endoprosthesis

Conditions

Aneurysm

Outcome Measures

Primary Outcomes (1)

• The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment

  Treatment through 1 month post treatment

Secondary Outcomes (8)

• The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment.

  Treatment through 1 month post procedure

• Procedure Time (Minutes)

  Initial Device Implant Procedure During Index Hospitalization

• Operative Blood Loss (mL)

  Initial Device Implant Procedure During Index Hospitalization

• Days of Convalescence Stay in an Intensive Care Unit

  During the Index Hospitalization

• Total Length of Hospital Stay (Days)

  Total Duration of the Index Hospitalization

Study Arms (1)

GORE CTAG Device

EXPERIMENTAL

The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.

Device: GORE CTAG Device

Interventions

GORE CTAG Device DEVICE

Endovascular aortic stent-graft

Also known as: GORE Conformable TAG® Thoracic Endoprosthesis

GORE CTAG Device

Eligibility Criteria

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

You may qualify if:

• \. Presence of DTA aneurysm deemed to warrant surgical repair \>
• Fusiform (≥50 mm), or \>
• Saccular (no diameter criteria)\> 2. Subject is \> 21 years of age\> 3. Proximal and distal landing zone length ≥ 2.0 cm \>
• Landing zones must be in native aorta\>
• Landing zone may include left subclavian artery, if necessary\> 4. All proximal and distal landing zone inner diameters are between 16-42 mm\>
• Diameter assessed by flow lumen and thrombus, if present; calcium excluded\> 5. Life expectancy \> 2 years\> 6. Able to tolerate thoracotomy \> 7. Male or infertile female\> 8. Able to comply with protocol requirements including following-up\> 9. Signed informed consent\>

You may not qualify if:

• Differing proximal and distal neck diameters (aortic taper) outside the intended aortic diameter requirements (sizing guide) for a single endoprosthesis diameter and the inability to use devices of different diameters (in adherence to the sizing guide) to compensate for the taper\>
• Tortuous or stenotic iliac and/or femoral arteries and inability to use a conduit for vascular access\>
• Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)\>
• Mycotic aneurysm\>
• Hemodynamically unstable aneurysm rupture\>
• Aortic dissection\>
• Planned coverage of left carotid or celiac arteries with the CTAG Device\>
• Planned concomitant surgical procedure (other than left subclavian transposition and wireless sac pressure monitoring), or major surgery within 30 days of treatment date\>
• Known degenerative connective tissue disease, e.g. Marfan or Ehler-Danlos Syndrome\>
• Known history of drug abuse\>
• ASA risk classification = V (moribund patient not expected to live 24 hours with or without operation)\>
• NYHA class IV \>
• Participating in another investigational device or drug study within 1 year of treatment\>
• Subject has known sensitivities or allergies to the device materials\>
• Subject has a systemic infection and may be at increased risk of endovascular graft infection\>

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (1)

University of Alabama Medical Center

Birmingham, Alabama, 35294, United States

Location

Related Publications (2)

• Jordan WD, Desai N, Letter AJ, Matsumura JS. Long-term outcomes of the conformable TAG thoracic endoprosthesis in a prospective multicenter trial. J Vasc Surg. 2021 Nov;74(5):1491-1498. doi: 10.1016/j.jvs.2021.04.063. Epub 2021 May 20.

  PMID: 34022380 DERIVED

• Panthofer AM, Olson SL, Harris DG, Matsumura JS. Derivation and validation of thoracic sarcopenia assessment in patients undergoing thoracic endovascular aortic repair. J Vasc Surg. 2019 May;69(5):1379-1386. doi: 10.1016/j.jvs.2018.08.180. Epub 2018 Dec 28.

  PMID: 30598352 DERIVED

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

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

aletter@wlgore.com

928-864-3113

Study Officials

• William D Jordan, Dr.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 2, 2009
• Study Start: June 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 6, 2017
• Last Updated: August 25, 2017
• Results First Posted: December 13, 2011

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)