Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246038
Status:
WITHDRAWN
Last Update Posted:
2015-08-31
First Post:
2005-10-27
Brief Title:
The Boston Scientific ENOVUS Trial
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
A Phase II Evaluation of the Safety and Efficacy of the Boston Scientific ENOVUS AAA Endograft in the Treatment of Abdominal Aortic Aneurysms
Status:
WITHDRAWN
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor cancelled the development program and never conducted the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective actively controlled consecutively enrolling non-randomized multi center clinical evaluation of the safety and efficacy of the Boston Scientific ENOVUS AAA Endograft when used in the treatment of patients with AAA Treatment Group as compared to patients treated with conventional open surgery Control Group
Detailed Description:
The primary objectives of this study are to determine whether the Boston Scientific ENOVUS AAA Endograft is a safe and effective method of treating AAAs in those patients considered to be suitable candidates for open surgical repair The safety of the Boston Scientific ENOVUS AAA Endograft will be determined by comparing the rate of major morbidity in the Treatment Group against the rate of major morbidity in the Control Group within 30 days of the initial procedure The efficacy of the Boston Scientific ENOVUS AAA Endograft will be determined by evaluating the proportion of patients in the Treatment Group that are free from AAA rupture and conversion to open surgical repair within 1 year of the initial procedure
The secondary safety endpoints will be compared between the Treatment and Control GroupsMortality rates at 30 days and 1 year AAA related mortality at 30 days and 1 year The secondary efficacy endpoints will be evaluated in the Treatment Group only and include Technical success enlargement of AAA migration significant endoleak and loss of device integrity Secondary Clinical Utility endpoints will be compared between the Treatment and Control groups and will include blood loss duration of procedure ICU stay length of hospital stay and duration of anesthesia
The secondary safety endpoints will be compared between the Treatment and Control GroupsMortality rates at 30 days and 1 year AAA related mortality at 30 days and 1 year The secondary efficacy endpoints will be evaluated in the Treatment Group only and include Technical success enlargement of AAA migration significant endoleak and loss of device integrity Secondary Clinical Utility endpoints will be compared between the Treatment and Control groups and will include blood loss duration of procedure ICU stay length of hospital stay and duration of anesthesia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None