Prospective Randomized Trial Comparing DEB Versus Conventional PTA for the Treatment of Hemodialysis AVF or AVG Stenoses (DEBAPTA)
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ClinicalTrials.gov Identifier: NCT01544907 |
Recruitment Status
:
Completed
First Posted
: March 6, 2012
Last Update Posted
: November 6, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | February 29, 2012 | |||
First Posted Date ICMJE | March 6, 2012 | |||
Last Update Posted Date | November 6, 2017 | |||
Study Start Date ICMJE | January 2012 | |||
Actual Primary Completion Date | November 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Late luminal loss [ Time Frame: 6 months ] 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.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01544907 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Prospective Randomized Trial Comparing DEB Versus Conventional PTA for the Treatment of Hemodialysis AVF or AVG Stenoses | |||
Official Title ICMJE | Prospective Randomized Trial Comparing Drug Eluting Balloon Angioplasty Versus Conventional Percutaneous Transluminal Angioplasty Balloon for the Treatment of Hemodialysis Arterio-Venous Fistula or Arterio-Venous Graft Stenoses | |||
Brief Summary | 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. | |||
Detailed Description | Introduction: Neointimal hyperplasia is the main cause of hemodialysis access [arterio-venous fistula (AVF) or graft (AVG)] dysfunction and thrombosis. Although endovascular techniques like percutaneous transluminal angioplasty (PTA), catheter directed thrombolysis, mechanical thrombectomy or bare metal stenting, may salvage the access, long term patency remains dismal due to recurrent stenosis from neointimal hyperplasia. Drug Eluting Balloon (DEB) is effective in inhibiting neointimal hyperplasia for treatment of coronary in-stent restenosis since 2006 and more recently in femoropopliteal arteries, reducing restenosis rates and prolonging patency. Specific Aim: To determine the efficacy of DEB in reducing restenosis rates and prolonging the patency of AVFs/AVGs compared to PTA. Hypothesis: DEB is superior to PTA in reducing late luminal loss and restenosis rates, while prolonging primary and secondary patencies. Methodology: Prospective, randomized clinical trial with study population comprising of patients with dysfunctional AVFs/AVGs due to underlying stenoses. The patients will be randomized to receive either DEB or PTA. The 6-month late luminal loss will be primary endpoint. The secondary endpoints of restenosis rate, primary and secondary patencies, will also be determined. Major Clinical Significance: Hemodialysis access failures constitute significant morbidity and costs to patient and healthcare system. Maintaining access patency consumes significant resources and constitutes a significant portion of the work of vascular surgeons, nephrologists and interventional radiologists. Any strategy that reduces access failure or prolonging access lifespan will be beneficial. If DEB is proven to be superior to PTA, there will be a paradigm shift in management of hemodialysis access failures from restenosis - similar to how DEB has changed practice in managing coronary artery in-stent restenosis. |
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
125 | |||
Original Estimated Enrollment ICMJE |
120 | |||
Actual Study Completion Date | November 2013 | |||
Actual Primary Completion Date | November 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 21 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Singapore | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01544907 | |||
Other Study ID Numbers ICMJE | DEBAPTA | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Singapore General Hospital | |||
Study Sponsor ICMJE | Singapore General Hospital | |||
Collaborators ICMJE | National Medical Research Council (NMRC), Singapore | |||
Investigators ICMJE |
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PRS Account | Singapore General Hospital | |||
Verification Date | November 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |