To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease

NCT00757003 | Completed Phase 3 Results

• 2 other identifiers: SU-09112008-129913335 (SQL 73498)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

PURPOSE OF RESEARCH: Endovascular stent-graft repair of aortic pathologies is a minimally-invasive alternative to open surgery that may decrease morbidity and mortality, particularly in high risk patients. Optimal patient selection, based on pathology and anatomy, is being defined. Technically successful implantation requires adequate assessment of pathology and anatomy, and development and execution of novel and delicate procedures that resolve the pathology while minimizing morbidity and mortality.

Conditions

Aneurysm, Dissecting; Aortic Aneurysm, Thoracic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Technically Successful Implant

  The percentage of participants with technically successful implantation as assessed by the investigator is reported.

  Day 0 to Day 30

Secondary Outcomes (2)

• Count of Participants Experiencing at Least One Endoleak Following Procedure

  Up to 60 months following procedure

• Overall Survival

  60 months

Study Arms (1)

Treatment Arm - Placement of TAG device

EXPERIMENTAL

A TAG device will be used to repair the pathology in the thoracic aorta

Device: Endovascular Stent-graft repair of descending thoracic aorta

Interventions

Endovascular Stent-graft repair of descending thoracic aorta DEVICE

A TAG device will be used to repair the pathology in the thoracic aorta

Treatment Arm - Placement of TAG device

Eligibility Criteria

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

You may qualify if:

• Patients should be poor or high risk open surgical candidates.
• Anatomy meets TAG Endoprosthesis specification criteria.
• Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm
• \<60 angle in the aortic arch may require additional length of non-aneurysmal segment is the arch is included in the treatment segment.
• Ability to comply with protocol requirements including follow-up.
• Signed Informed Consent

You may not qualify if:

• \>4mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta.
• Significant thrombus at the proximal or distal implantation sites.
• Planned occlusion of the left carotid or celiac arteries, unless supplemental conduit or alternate perfusion routes for end organ(s) provided.
• Degenerative connective tissue disease, e.g. Marfan's or Ehler's Danlos Syndrome, unless the proximal and distal implantation sites of the TAG Endoprosthesis are located with in previous surgical grafts.
• \. Female of child bearing age with positive pregnancy test.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Aortic Dissection; Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Aortic Aneurysm

Results Point of Contact

• Title: Dr. Daniel Sze, Principal Investigator
• Organization: Stanford University

dansze@stanford.edu

650-723-0728

Study Officials

• Daniel Yung-Ho Sze

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 18, 2008
• First Posted: September 22, 2008
• Study Start: October 1, 2001
• Primary Completion: July 1, 2013
• Study Completion: May 1, 2014
• Last Updated: March 1, 2017
• Results First Posted: March 1, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)