Characteristics Predictive of Success and Complications in the Use of Suture-Mediated Closure of Femoral Venous Access
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Characteristics Predictive of Success and Complications in the Use of Suture-Mediated Closure of Femoral Venous Access|
- To determine the safety and effectiveness of the suture-mediated closure devices in closing femoral venous access sites. [ Time Frame: Within 30 days of procedure/closure ] [ Designated as safety issue: Yes ]
- To identify factors that are predictive of success and failure of the suture mediated closures. [ Time Frame: Within 30 days of procedure/closure ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Estimated Study Completion Date:||May 2009|
|Estimated Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
All pts. who have undergone percutaneous intervention who received a suture-mediated closure of the venous access site will be screened for eligibility for this research trial.
Procedure: suture mediated closure
Suture mediated closure of femoral venous access
Other Name: Suture mediated closure of femoral venous access
This is a retrospective cohort study of consecutive patients receiving suture-mediated closure of the femoral vein following catheterization. All patients undergoing cardiac or arterial catheterization by the Interventional Cardiovascular Medicine Service at The Brigham and Women's hospital from 3/1/02 to the onset of the study and who had femoral venous access during that time were considered for closure of the venous site; however, the decision to use the closure device was left to the discretion of the physician. Contraindications to using the closure device include a groin hematoma that had developed during the procedure and/or difficult access due to extensive scar tissue from surgery or multiple prior vascular accesses.
All in-hospital endpoints have been collected in the pre-existing Catheterization Laboratory Database. Patient's data will be extracted from this database as indicated in the procedure below. Each patient will be reviewed for clinical follow-up and the presence of adverse events including but not limited to hematoma, thrombosis, blood loss, vascular imaging, the need for additional procedures, and re-admissions within 30 days of closure. If necessary, further data will be collected via a phone interview with the patients. Univariate and multivariate analysis will be performed to determine the factors that predict inadequate or incomplete closure or the development of complications mentioned in the section above. A predictive model based on the identified risk factor will be developed and tested prospectively in the next phase of this ongoing investigation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838175
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Andrew C Eisenhauer, MD||Brigham and Women's Hospital|