Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With Abdominal Aortic Aneurysms (AAA)

• Sponsor: Rodney A. White, M.D. (Other)
• Overall Status: Completed
• CT.gov ID: NCT00695253
• Collaborator: (none)
• Enrollment: 49
• Location: 1
• Arm: 1
• Duration (Months): 131
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the Talent Endoluminal Spring Graft System, an investigational device, to treat abdominal aortic aneurysms (AAA). The treatment population will include patients with an abdominal aortic aneurysm who meet the inclusion/exclusion criteria. All patients in the treatment population will undergo post-procedure follow-up evaluations at one (1), six (6), and 12 months and annually thereafter up to five (5) years post-procedure.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysms	Device: Talent Endoluminal Spring Graft System	N/A

Detailed Description

Endovascular aneurysm repair (EVAR) offers certain advantages as compared to surgical repair of an abdominal aortic aneurysm. Known benefits associated with EVAR, as described in scientific literature, include minimally invasive procedure, shorter ICU and hospital stay, reduced blood loss, more rapid recovery, and reduced need for general anesthesia. Potential benefits that may be associated with use of the Talent device include reduced occurrence of endoleaks, therefore reduced subsequent re-interventions. The risks/complications known to occur to all patients undergoing AAA repair may include anesthetic complications, (e.g., aspiration), aneurysm enlargement, rupture, perforation or dissection, bleeding, arterial or venous thrombosis and/or pseudoaneurysm, arteriovenous fistula, hematoma or coagulopathy, bowel complications, cardiac complications, (e.g., arrhythmia, myocardial infarction, congestive heart failure, hypotension, hypertension), embolization (micro and macro) with transient or permanent ischemia or infarction, genitourinary complications, infection, neurologic complications, occlusion of device or native vessel, pulmonary/respiratory complications and renal complications.

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With AAA
• Study Start Date: Apr 1, 2002
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: Talent Endoluminal Spring Graft System Single Arm study of the endoluminal treatment of Abdominal Aortic Aneurysms using the Talent Endoluminal Spring Graft System	Device: Talent Endoluminal Spring Graft System; Endovascular repair for patients with AAA who meet the inclusion criteria for the study

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Successful Exclusion of Abdominal Aortic Aneurysm [From the date of treatment assessed up to 5 years post treatment.]

   The safety and effectiveness of the endoluminal device was determined by the number participants with successful exclusion of the abdominal aortic aneurysm (AAA).

Secondary Outcome Measures

1. Number of Participants With Successful Device Delivery and Deployment. [From the date of treatment assessed up to 5 years post treatment.]

   Delivery success is defined as the successful access of the vessel and insertion of the delivery sheath to the treatment site. Deployment success is defined as the advancement through the vasculature to the desired location and full deployment within 0.5 cm of the intended location. Aneurysm exclusion is achieved when there is no evidence of blood flow around or through the stent graft into the aneurysm or where there is an absence of contrast within the aneurysm sac.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects who participate in this study must fulfill all of the following criteria.

• Subject is > 18 years of age.

• Subject is not pregnant, and, if female and of child-bearing potential, is practicing contraception.

• Subject has documented evidence of at least one patent internal iliac artery.

• Subject has an AAA that is dilated to > 4 cm in diameter.

• Subject has a proximal AAA neck (distance between the top of the aneurysm and the renal arteries) > 5 mm.

• Subject has a proximal aortic neck diameter > 14 mm and < 32 mm.

• Subject has an angle between the suprarenal aorta and the aneurysm <60o.

• Subject has renal arteries > 9 cm from the aortic bifurcation.

• Subject has proximal and distal iliac neck diameters > 8 mm and < 18 mm to accommodate stock devices. For those subjects whose proximal and distal iliac diameters are > 18 mm, custom devices with a variation in fixation diameters will be ordered from the manufacturer.

• Subject has a distal iliac neck length > 15 mm.

• Subject has signed informed consent.

• Subject will be available for follow-up for 12 months after the procedure.

Exclusion Criteria:

• Subjects who fulfill any of the following criteria may not participate in this study.

• Subject has patent internal iliac arteries that require graft extension to the external iliac arteries.

• Subject has one or more patent subrenal arteries with potential retrograde flow after stent-grafting.

• Subject has a dominant patent inferior mesenteric artery and an occluded or stenotic celiac and superior mesenteric artery.

• Subject has an aneurysm involving both internal iliac arteries.

• Subject has a lesion that cannot be crossed with a guide wire.

• Subject whose arterial access site cannot accommodate the delivery catheter.

• Subject has no distal vascular bed.

• Subject has systemic infection, or is suspected of having systemic infection.

• Subject has contraindications for use of contrast medium or anticoagulation drugs.

• Subject has received a previous stent in the subrenal aorta.

• Subject has an untreatable bleeding diathesis.

• Subject is in a hypercoagulable state.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LAC Harbor-UCLA Medical Center	Torrance	California	United States	90502

Sponsors and Collaborators

• Rodney A. White, M.D.

Investigators

• Principal Investigator: Rodney A. White, M.D., Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rodney A. White, M.D., Chief, Vascular Surgery, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• ClinicalTrials.gov Identifier: NCT00695253
• Other Study ID Numbers: 10807-01
• First Posted: Jun 11, 2008
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Rodney A. White, M.D., Chief, Vascular Surgery, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: AAA
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal

Study Results

Participant Flow

Recruitment Details	About 75 patients were screened for eligibility for enrollment in the study based on the inclusion/exclusion criteria. Participants were selected over a 7 year period between 2002 and 2008 and were made up of patients in the hospital, clinic patients as well as those referred from other clinics and facilities.

Arm/Group Title	Talent Endoluminal Spring Graft System
Arm/Group Description	All participants who were diagnosed with abdominal aortic aneurysms and who were eligible for enrollment as defined by the inclusion/exclusion criteria were screened. These patients included both high and low risk patients who signed a consent to participate in this Physician-sponsored IDE for the endoluminal treatment of their abdominal aneurysm using the Medtronic/Talent Stent Graft: Stent-graft for Abdominal Aortic Aneurysms.
Period Title: Overall Study
STARTED	49
COMPLETED	18
NOT COMPLETED	31

Baseline Characteristics

Arm/Group Title	There Are no Study Arms.
Arm/Group Description	All participants who were diagnosed with abdominal aortic aneurysms and who were eligible for enrollment as defined by the inclusion/exclusion criteria were screened. These patients included both high and low risk patients who signed a consent to participate in this Physician-sponsored IDE for the endoluminal treatment of their abdominal aneurysm using the Medtronic/Talent Stent Graft: Stent-graft for Abdominal Aortic Aneurysms.
Overall Participants	49
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 10.2%
>=65 years	44 89.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74.64 (3.78)
Sex: Female, Male (Count of Participants)
Female	1 2%
Male	48 98%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2%
Not Hispanic or Latino	48 98%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 2%
Native Hawaiian or Other Pacific Islander	1 2%
Black or African American	5 10.2%
White	42 85.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	49 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Successful Exclusion of Abdominal Aortic Aneurysm
Description	The safety and effectiveness of the endoluminal device was determined by the number participants with successful exclusion of the abdominal aortic aneurysm (AAA).
Time Frame	From the date of treatment assessed up to 5 years post treatment.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Number of Successful Exclusion of Abdominal Aortic Aneurysms
Arm/Group Description	The safety and effectiveness of the endoluminal device was determined by the number of abdominal aortic aneurysms (AAA) that were successfully excluded.
Measure Participants	49
Number [participants' AAA]	49 100%

2. Secondary Outcome

Title	Number of Participants With Successful Device Delivery and Deployment.
Description	Delivery success is defined as the successful access of the vessel and insertion of the delivery sheath to the treatment site. Deployment success is defined as the advancement through the vasculature to the desired location and full deployment within 0.5 cm of the intended location. Aneurysm exclusion is achieved when there is no evidence of blood flow around or through the stent graft into the aneurysm or where there is an absence of contrast within the aneurysm sac.
Time Frame	From the date of treatment assessed up to 5 years post treatment.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Number of Successful Device Delivery and Deployment
Arm/Group Description	All participants who were diagnosed with abdominal aortic aneurysms and who were eligible for enrollment as defined by the entry criteria were screened. These patients included both high and low risk patients who signed a consent to participate in this Physician-sponsored IDE for the endoluminal treatment of their abdominal aneurysm using the Medtronic/Talent Stent Graft: Stent-graft for Abdominal Aortic Aneurysms.
Measure Participants	49
Count of Participants [Participants]	49 100%

Adverse Events

Time Frame	From the data of treatment until the date of death from any event or the date of the adverse event assessed up to five years. Participants were followed for the duration of the study, an average of 5 years.
Arm/Group Title	Talent Endoluminal Spring Stent Graft System
Arm/Group Description	Endoluminal treatment of abdominal aortic aneurysms using the Medtronic/Talent Stent Graft: Stent-graft for all patients with abdominal aortic lesions who signed consent into this Physician - Sponsored IDE.
All Cause Mortality
	Talent Endoluminal Spring Stent Graft System
	Affected / at Risk (%)	# Events
Total	19/49 (38.8%)
Serious Adverse Events
	Talent Endoluminal Spring Stent Graft System
	Affected / at Risk (%)	# Events
Total	29/49 (59.2%)
Cardiac disorders
Myocardial infarction	2/49 (4.1%)	2
Congestive Heart Failure	2/49 (4.1%)	2
Renal and urinary disorders
Renal Cancer	1/49 (2%)	1
Reproductive system and breast disorders
Prostate cancer	1/49 (2%)	1
Respiratory, thoracic and mediastinal disorders
Lung Cancer	6/49 (12.2%)	6
Vascular disorders
Vessel Injury	1/49 (2%)	1
Endoleak	9/49 (18.4%)	9
Ruptured AAA	1/49 (2%)	1
Ruptured TAA	1/49 (2%)	1
Stent Graft migration	2/49 (4.1%)	2
Stent Graft occlusion	3/49 (6.1%)	3
Other (Not Including Serious) Adverse Events
	Talent Endoluminal Spring Stent Graft System
	Affected / at Risk (%)	# Events
Total	4/49 (8.2%)
Vascular disorders
Hypertension	2/49 (4.1%)	2
Peripheral Vascular Disease	2/49 (4.1%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.