Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Cleveland, Ohio 44195


Purpose:

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


Study 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. 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.


Criteria:

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


Study is Available At:


Original ID:

G010002


NCT ID:

NCT00583050


Secondary ID:

IRB 4281


Study Acronym:


Brief Title:

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


Official Title:

Endovascular Exclusion of Thoracoabdominal Aortic Aneurysms or Abdominal Aneurysms Utilizing Fenestrated/Branched Stent-Grafts


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The Cleveland Clinic


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

1440


Enrollment Type:

Anticipated


Overall Contact Information

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

Study Dates

Start Date:February 2001
Completion Date:December 2020
Completion Type:Anticipated
Primary Completion Date:December 2020
Primary Completion Type:Anticipated
Verification Date:July 2019
Last Changed Date:July 25, 2019
First Received Date:December 20, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:Freedom from Aneurysm Rupture
Time Frame:2 years
Safety Issues:False
Description:Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan

Study Interventions

Intervention Type:Device
Name:Endovascular Aneurysm Repair
Description:Endovascular exclusion of aneurysm
Arm Name:Endovascular Aneurysm Repair
Other Name:Cook Zenith

Study Arms

Study Arm Type:Experimental
Arm Name:Endovascular Aneurysm Repair
Description:Endovascular Aneurysm Repair of TAAA/AAA with Fenestrated/Branched Stent Grafts

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The Cleveland Clinic
Agency Class:Other
Agency Type:Collaborator
Agency Name:Massachusetts General Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.