Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094575
Status:
COMPLETED
Last Update Posted:
2016-03-07
First Post:
2004-10-20
Brief Title:
Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm AAA
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 498 - Open Versus Endovascular Repair OVER Trial for Abdominal Aortic Aneurysms
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OVER
Brief Summary:
A multi-center randomized clinical trial that will compare endovascular repair with standard open surgery in the repair of abdominal aortic aneurysms AAA Long and short-term results as well as the cost and quality of life associated with these two strategies for AAA repair will be compared
Detailed Description:
Primary Hypothesis All-cause mortality will differ by 25 between Endovascular repair EVR and Open repair Secondary Hypotheses Procedure failure short term 12-month major morbidity number of hospital days health-related quality of life and other procedure-related abnormalities will differ between the two AAA repair strategies Primary Outcomes All-cause mortality Interventions Patients will be randomized to one of these repair strategies for the elective treatment of AAA a Open repair or b Endovascular repair using FDA-approved devices Study Abstract Aortic aneurysm is the tenth leading cause of death in older men AAA accounts for the majority of these deaths about 10000 deaths per year in the United States Since one in 22 Veterans over the age of 50 have AAA and one in 200 have AAA with diameter greater or equal to 50 cm making them candidates for elective repair AAA is a major disease in the VA population Questions about the relative safety and effectiveness of FDA approved EVR devices have been raised and remain unanswered To answer these questions this multi-center randomized clinical trial comparing EVR with standard open surgery is proposed Patients for whom elective repair of AAA is indicated and who are suitable candidates for both open repair and EVR will be eligible for the study The anticipated duration of the study is 9 years with a proposed sample size of 900 patients The first planning meeting took place on March 9-10 2000 and the second planning meeting took place on November 6-7 2000 The OVER protocol was submitted and reviewed by CSEC on May 10 2001 and approved The kickoff was June 12 2002 The first DSMB meeting took place January 6 2003 First annual meeting was held September 30 2003 second DSMB meeting took place September 29 2003 Third DSMB meeting held on April 19 2004 second annual meeting was held on June 29 2004 Fourth DSMB meeting was held on December 6 2004 third annual meeting was held on March 15 2005 The fifth DSMB meeting was held on July 19 2005 and the fourth annual meeting was held March 21 2006 The sixth DSMB meeting was held September 12 2005 The seventh DSMB meeting was held on March 6 2006 The eighth DSMB meeting was held on November 6 2006 At its November 6 2006 meeting the DSMB discussed and approved unblinding of the study chair to prepare the short-term follow-up paper as specified in the study protocol Initially the protocol called for this analysis to include one-year follow-up data After discussions with the Trial Leadership the DSMB approved use of two year follow-up data reflected in DSMB minutes finalized February 20 2007 This recommendation was subsequently approved by CSP in March 2007 The short-term outcomes manuscript was published in JAMA on October 14 2009 The ninth DSMB meeting was held on May 14 2007 and the fifth annual meeting was held on June 6 2007 The tenth DSMB meeting was held on April 7 2008 The eleventh DMC name change only from DSMB to DMC was held on June 22 2009 The twelfth DMC meeting was held on May 24 2010 A Site Investigator meeting was held in Boston MA on June 9 2010 The thirteenth DMC meeting was held on June 3 2011 and a study close-out meeting was held on June 15 2011 in Chicago IL The studys patient follow-up phase ended October 15 2011
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