Endovascular Exclusion of TAAA/AAA Utilizing Fenestrated/Branched Stent Grafts

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00583050
• Collaborator: Massachusetts General Hospital (Other)
• Enrollment: 1,366
• Location: 1
• Arm: 1
• Actual Duration (Months): 228
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms.

Condition or Disease	Intervention/Treatment	Phase
Thoracoabdominal Aneurysm; Abdominal Aortic Aneurysm	Device: Endovascular Aneurysm Repair	N/A

Detailed Description

The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms. The evaluation shall be conducted with subjects that would be expected to have great difficulty tolerating open surgical repair and anatomies not suitable for devices currently marketed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1366 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Endovascular Exclusion of Thoracoabdominal Aortic Aneurysms or Abdominal Aneurysms Utilizing Fenestrated/Branched Stent-Grafts
• Actual Study Start Date: Feb 1, 2001
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endovascular Aneurysm Repair Endovascular Aneurysm Repair of TAAA/AAA with Fenestrated/Branched Stent Grafts	Device: Endovascular Aneurysm Repair; Endovascular exclusion of aneurysm; Other Names: Cook Zenith

Outcome Measures

Primary Outcome Measures

1. Freedom From Aneurysm Rupture [2 years]

   Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. At least 18 years of age.

2. Not pregnant

3. Willing and able to comply with two-year follow-up period.

4. Willing and able to give informed consent prior to enrollment

5. No known allergy to stainless steel or polyester

6. No history of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately.

7. Life expectancy greater than two years

8. High risk candidate for open surgical repair

Exclusion Criteria:

see above

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic
• Massachusetts General Hospital

Investigators

• Principal Investigator: Behzad Farivar, M. D., The Cleveland Clinic

Study Documents (Full-Text)

• Study Protocol - Jan 1, 2018
• Statistical Analysis Plan - Mar 9, 2006
• Informed Consent Form - May 1, 2017

More Information

Publications

None provided.

• Responsible Party: Behzad Farivar, M. D., Principal Investigator, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT00583050
• Other Study ID Numbers: G010002; IRB 4281
• First Posted: Dec 31, 2007
• Last Update Posted: May 8, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal

Study Results

Participant Flow

Arm/Group Title	Endovascular Aneurysm Repair
Arm/Group Description	Treatment Arm: Subjects with abdominal/thoracoabdominal aneurysm undergoing endovascular aneurysm repair
Period Title: Overall Study
STARTED	1366
COMPLETED	1366
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Endovascular Aneurysm Repair
Arm/Group Description	Treatment Arm: Subjects with abdominal/thoracoabdominal aneurysm undergoing endovascular aneurysm repair
Overall Participants	1366
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	141 10.3%
>=65 years	1225 89.7%
Sex: Female, Male (Count of Participants)
Female	315 23.1%
Male	1051 76.9%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	1366 100%
Presence of abdominal or thoracoabdominal aneurysm (Count of Participants)
Count of Participants [Participants]	1366 100%

Outcome Measures

1. Primary Outcome

Title	Freedom From Aneurysm Rupture
Description	Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endovascular Aneurysm Repair
Arm/Group Description	Treatment Arm: Subjects with abdominal/thoracoabdominal aneurysm undergoing endovascular aneurysm repair
Measure Participants	1366
Count of Participants [Participants]	22 1.6%

Adverse Events

Time Frame	2 years
Arm/Group Title	Endovascular Aneurysm Repair
Arm/Group Description	Treatment Arm: Subjects with abdominal/thoracoabdominal aneurysm undergoing endovascular aneurysm repair
All Cause Mortality
	Endovascular Aneurysm Repair
	Affected / at Risk (%)	# Events
Total	775/1366 (56.7%)
Serious Adverse Events
	Endovascular Aneurysm Repair
	Affected / at Risk (%)	# Events
Total	22/1366 (1.6%)
Vascular disorders
Aneurysm Rupture	22/1366 (1.6%)
Other (Not Including Serious) Adverse Events
	Endovascular Aneurysm Repair
	Affected / at Risk (%)	# Events
Total	68/1366 (5%)
Vascular disorders
Aneurysm size increase	68/1366 (5%)

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.