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

NCT00597870 | Completed Results DMC

• 1 other identifier: 10837-01
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thoracic Aortic Aneurysms; Thoracic Transections; Intramural Hematoma; Pseudoaneurysm; Thoracic Aortic Dissection

Keywords

TAA

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Successful Endoluminal Treatment of Thoracic Lesion

  Evaluate the number of patients who had successful treatment of their thoracic lesion using the Medtronic Talent Endoluminal Stent Graft..

  Throughout study completion, an average of 1 year

Secondary Outcomes (1)

• Number of Participants With Successful Device Delivery and Deployment

  Throughout study completion, an average of 1 year

Study Arms (1)

Treatment of Thoracic Lesions

EXPERIMENTAL

Endoluminal treatment of thoracic lesions

Device: Endoluminal treament of thoracic lesions

Interventions

Endoluminal treament of thoracic lesions DEVICE

Endoluminal treament of thoracic lesions with a thoracic stent-graft

Treatment of Thoracic Lesions

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Rodney A. White, M.D.: lead

Study Sites (1)

LAC Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Aneurysm, False; Dissection, Thoracic Aorta

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Rodney A. White, MD
• Organization: Lundquist Institute of BioMedical Studies

rawhite@ucla.edu

3109635230

Study Officials

• Rodney A. White, M.D.

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Vascular Surgery

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 18, 2008
• Study Start: May 1, 2002
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: September 14, 2023
• Results First Posted: September 14, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)