Clipped Versus Handsewn Arteriovenous Fistula Anastomosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01669850|
Recruitment Status : Terminated (minimal accrual)
First Posted : August 21, 2012
Last Update Posted : September 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Arteriovenous Fistula Complications and Failure||Device: Clipped anastomosis Procedure: Handsewn anastomosis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Safety and Effectiveness of Clipped Technique vs. Hand-Sewn Technique for Anastomosis in Arteriovenous Fistulas|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Clipped anastomosis
A vascular clip device will be used to create the anastomosis during arteriovenous fistula creation.
Device: Clipped anastomosis
The vascular clip devise will be used to complete the anastomosis during fistula creation.
Other Name: Anastoclip (Le Maitre)
Active Comparator: Handsewn anastomosis
A handsewn technique will be used to create the anastomosis in arteriovenous fistula creation.
Procedure: Handsewn anastomosis
a handsewn anastomosis technique will be used during fistula creation.
- Patency rates [ Time Frame: 2 years postoperative ]Patency will be assessed and the fistula considered patent if it has been accessed for dialysis at least once, or based on clinical assessment with palpable thrill if dialysis access has not been attempted.
- Surgical complications [ Time Frame: 2 years postoperative ]Complications will be monitored intraoperatively, and postoperatively. These include any re-interventions, and wound complications, infection, hematoma, thrombosis , steal syndrome, distal ischemia.
- Cost [ Time Frame: 1 year postoperative ]Cost for the vascular clip device will be compared to cost of the handsewn technique.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669850
|United States, Wisconsin|
|Gundersen Lutheran Health System|
|La Crosse, Wisconsin, United States, 54601|
|Principal Investigator:||Clark A Davis, MD||Gundersen Lutheran Health System|