Physician-Sponsored IDE for the Talent Endoluminal Stent Graft System for the Treatment of Thoracic Lesions

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Los Angeles Biomedical Research Institute
Sponsor:
Information provided by (Responsible Party):
Rodney A. White, M.D., Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT00597870
First received: December 28, 2007
Last updated: January 13, 2016
Last verified: January 2016
  Purpose
The primary objective of this trial is to determine whether the Talent Thoracic Stent Graft, an investigational device, is a safe and effective method of treating thoracic aortic aneurysms (abnormal ballooning of the vessel wall) and other thoracic lesions (dissections, transections, pseudoaneurysms, penetrating ulcers, etc.). The endovascular method is a substitute for the major operation that is performed to treat the lesions.

Condition Intervention
Thoracic Aortic Aneurysms
Thoracic Transections
Intramural Hematoma
Pseudoaneurysm
Thoracic Aortic Dissection
Device: Endoluminal treament of thoracic lesions

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Physician-Sponsored IDE for the Talent Endoluminal Stent Graft System for the Treatment of Thoracic Lesions

Resource links provided by NLM:


Further study details as provided by Los Angeles Biomedical Research Institute:

Primary Outcome Measures:
  • The primary objective of this investigational plan is to determine the safety of the Medtronic/Talent device when used to exclude thoracic lesions: true descending thoracic aortic aneurysms, dissections, penetrating ulcers, traumatic transections. [ Time Frame: open ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the proportion of patients who experience adverse events during and after the implantation procedure, including comorbidities and overall mortality rates. [ Time Frame: open ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: May 2002
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment of Thoracic Lesions
Endoluminal treatment of thoracic lesions
Device: Endoluminal treament of thoracic lesions
Endoluminal treament of thoracic lesions with a thoracic stent-graft

Detailed Description:

The endovascular method consists of the insertion of catheters (vinyl tubes) into both groin arteries. These catheters then allow positioning of artificial tubes or stent graft(s) into the diseased blood vessel without the need for major surgery which involves opening the chest. The blood vessel problem (thoracic aortic aneurysm/lesion) will be treated using an artificial bypass tube (stent graft) that will be placed inside the diseased artery. The stent graft(s) that will be used are made of polyester graft fabric sewn to a self-expanding nickel-titanium (Nitinol) wire frame and is manufactured by Medtronic AVE, Santa Rosa California.

Aneurysms/lesions can be located in any position along the length of the aorta. This study evaluates only aneurysms/lesions that occur in the descending part of the thoracic aorta as it traverses the chest and enters the abdominal cavity. The risk of thoracic aneurysms/lesions is that they rupture without warning. The risk of rupture increases as the aneurysm size increases. Following rupture, almost all patients expire within the first 24 hours. For this reason treatment of thoracic aneurysms/lesions is recommended by conventional surgical means if the patient is a candidate for an operation. The conventional operation involves occluding the aorta and replacing the aneurysm with a cloth tube that is sewn to replace the diseased part of the aorta. The major surgery and occlusion of the aorta that is part of the conventional surgery is directly related to several complications that have been reported in the literature. In addition, many patients are too ill for conventional surgery due to concomitant illnesses.

After the procedure, the patient will be followed at regular intervals (pre-discharge, 1 month, 6 months, 12 months and every year thereafter for life) as part of the evaluation of the experimental treatment. During this time, the patient will have several tests performed to evaluate the function of the repair. The tests will include clinical examination, x-rays of the chest and spiral CT scan. The experimental part is the placement of the TALENT Stent-Graft System using the catheter (endovascular) methods. The risk of the experimental catheter bypasses is that the procedure may not be successful. In most cases, this would require a standard operation to repair the problem. Sometimes there are other risks such as injury to the vessels. Small pieces of diseased arteries may be dislodged which may require removal. Bleeding may occur from introduction sites, and rarely, infection may develop. If a catheter bypass is unsuccessful, there can be added discomfort because the procedure may last longer.

The benefits of the procedure are that the patient might avoid some of of the pain and discomfort associated with standard operations. Major surgery is avoided and hospital stay may be much shorter. Patients may be able to return to usual daily activities sooner. In addition, patients who are too high risk for conventional surgical treatment can have their aneurysm treated using the endovascular graft if their anatomy is appropriate

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects who participate in this study as study patients must fulfill the following criteria:

  • Subject is > 18 years of age.
  • Subject is not pregnant or lactating. Females of child-bearing potential must practice a reliable method of contraception.
  • Subject is diagnosed with one of the following conditions of the descending thoracic aorta. All conditions must be verified by diagnostic imaging [ultrasonography, computed tomography (CT), magnetic resonance imaging (MRI) or angiography].

    • A true (i.e., atherosclerotic) supraceliac aneurysm (fusiform or saccular type) with or without a co-existing aortic dissection or penetrating aortic ulcer
    • Aortic dissection of DeBakey Type I or II (Stanford A, proximal) in the absence of an aneurysm; OR
    • Penetrating aortic ulcer in the absence of an aneurysm; OR
    • Traumatic transection; OR
    • Pseudoaneurysm - traumatic or degenerative (i.e., one that does not involve all layers of the vessel and is not atherosclerotic in origin).
  • Subject's anatomy is suitable for placement of the Medtronic/Talent Stent-Graft, with a distinct proximal aneurysm neck of 10 mm or more in length and a distal aneurysm neck of at least 10 mm.
  • Subject has a TAA that is dilated to > 5 cm in diameter, > 1.5 times the diameter of the adjacent native/non-aneurysmal aorta, or is symptomatic.
  • Subject has a proximal and distal aortic neck diameter > 18 mm and < 42 mm.
  • Subject has an arterial access site, either peripherally or via infrarenal abdominal aorta that is adequate for introduction of the stent-graft delivery system.
  • Subject is competent to give informed consent.
  • Subject will be available for the periodic follow-up (surveillance) after the procedure.

Exclusion Criteria:

  • Subjects who would participate as study subjects and who fulfill any of the following criteria may not participate in this study:
  • Subject has TAA with less than 10 mm proximal fixation length.
  • Subject has an aneurysm that would require exclusion by the stent-graft of the segment of the aorta that gives rise to dominant spinal cord/intercostal arteries.
  • Subject has a lesion that prevents delivery or expansion of the device.
  • Subject has systemic infection, or is suspected of having systemic infection.
  • Subject has a known mycotic aneurysm.
  • Subject is not available or is not willing to come back for periodic follow-up (surveillance) after the procedure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597870

Contacts
Contact: Rodney A. White, M.D. 310 222-2704 rawhite@ucla.edu
Contact: Carlos E. Donayre, M.D. 310 222-2704 cdonayre@cox.net

Locations
United States, California
LAC Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: Rodney A. White, M.D.    310-222-2704    rwhite@ucla.edu   
Contact: Carlos E. Donayre, M.D.    310 222-2704    cdonayre@cox.net   
Principal Investigator: Rodney A. White, M.D.         
Sub-Investigator: Carlos E. Donayre, M.D.         
Sub-Investigator: Irwin Walot, M.D.         
Sponsors and Collaborators
Rodney A. White, M.D.
Investigators
Principal Investigator: Rodney A. White, M.D. Los Angeles Biomedical Research Institute
  More Information

Responsible Party: Rodney A. White, M.D., Chief, Vascular Surgery, Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT00597870     History of Changes
Other Study ID Numbers: 10837-01 
Study First Received: December 28, 2007
Last Updated: January 13, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Los Angeles Biomedical Research Institute:
TAA

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Hematoma
Aortic Aneurysm, Thoracic
Aneurysm, False
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2016