NCT01544907|CompletedDMC
Prospective Randomized Trial Comparing DEB Versus Conventional PTA for the Treatment of Hemodialysis AVF or AVG Stenoses
DEBAPTA
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DEBAPTA
Sponsor study identifier
interventional
125
1 country
1
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2013
Actual (reported)Study Completion
November 2013
Actual (reported)A prospective randomized trial comparing the efficacy of drug eluting balloon angioplasty versus conventional percutaneous transluminal angioplasty balloon for the treatment of hemodialysis arterio-venous fistula or arterio-venous graft stenoses in reducing late luminal loss and restenosis rates, while prolonging primary and secondary patencies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
February 29, 2012
Actual (reported)March 6, 2012
Actual (reported)November 2013
Actual (reported)November 2013
Actual (reported)Late luminal loss
Late luminal loss is defined as the difference between the minimum lumen diameters after angioplasty and at the end of the 6-month follow-up angiogram.
6 months
Restenosis rate
6 months
Primary patency
6 months
Primary assisted patency
6 months
Secondary patency
6 months
Anatomic success
Immediate post procedure
Treatment Arm 1- Conventional PTA only The conventional balloon is used and the diameter of the balloon should be the same or oversized by 1mm the diameter of the reference vessel. An inflation device with a pressure gauge is used to inflate up to manufacturers' stated burst pressure. The duration of balloon inflation will be 2 minutes. At the end of the first angioplasty, an AVFistulogram/AVGraftogram will be obtained to document results. If there is residual stenosis of \>30%, a repeat angioplasty using the same balloon or another appropriately oversized balloon by 1mm will be used for an additional 2 minutes. A final angiogram will be obtained for documentation.
Treatment arm 2 - Conventional Balloon with DEB A Conventional balloon is used to pre-dilate the target lesion. The DEB of a similar diameter to the conventional balloon used is then inflated across the stenosis. An inflation device with a pressure gauge is used to inflate up to manufacturers' stated burst pressure. The duration of balloon inflation will be 1 minute. A final angiogram will be obtained for documentation. The drug coated on the DEB is Paclitaxel.
Use of conventional balloon for angioplasty only
Use of DEB after conventional balloon angioplasty
Singapore General Hospital
Singapore, 169068, Singapore
Farah G Irani, MBBS,FRCR
Singapore General Hospital
125 participants (actual enrollment reported by the registry).
First Submitted
February 29, 2012
First Posted
March 6, 2012
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
November 2013
Actual (reported)Study Completion
November 2013
Actual (reported)Last Updated
November 6, 2017
Record last verified: 2017-11
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Source: ClinicalTrials.gov.
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