Prospective Randomized Trial Comparing DEB Versus Conventional PTA for the Treatment of Hemodialysis AVF or AVG Stenoses

Stenosis of Arteriovenous Dialysis Fistula Clinical Trial

— DEBAPTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544907
• Other study ID #: DEBAPTA
• Status: Completed
• Phase: N/A
• First received: February 29, 2012
• Last updated: November 2, 2017
• Start date: January 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2017
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Upper limb or groin AVF/AVG

2. The AVF/AVG is > 3 months old.

3. Native vessel measures between 4 to 7 mm diameter (corresponding to the sizes of available DEBs).

4. The fistula or graft must not be thrombosed.

5. Able to cross with guide wire

6. Platelet count >50,000/l (platelet infusion if <100,000/l)

7. PT/PTT not more than 3 seconds above normal (FFP infusion for abnormal PT/PTT)

Exclusion Criteria:

1. Uncorrectable coagulopathy (despite transfusion) or hypercoagulable state.

2. Evidence of systemic infection or a local infection associated with the fistula or graft.

3. The patient is < 21 years of age.

4. The patient is pregnant.

5. Patient is enrolled in another investigational study

6. Patient has comorbid conditions that may limit their ability to comply with the follow-up requirement.

7. Life expectancy < 6 months

Related Conditions & MeSH terms

• Arteriovenous Graft Stenosis
• Constriction, Pathologic
• Fistula
• Stenosis of Arteriovenous Dialysis Fistula

Intervention

Device:
• Conventional PTA
Use of conventional balloon for angioplasty only
• Drug Eluting Balloon (DEB)
Use of DEB after conventional balloon angioplasty

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore General Hospital	National Medical Research Council (NMRC), Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Restenosis rate	Restenosis rate is defined as the incidence of stenosis =50% of the diameter of the reference vessel segment.	6 months
Secondary	Primary patency	Primary patency is defined as the interval from balloon angioplasty until the next access thrombosis or repeated intervention to maintain access function, or until access abandonment if no interval intervention. It ends with treatment of a lesion anywhere within the access circuit, from the arterial inflow to the superior vena cava-right atrial junction.	6 months
Secondary	Primary assisted patency	Primary assisted patency is defined as the interval from balloon angioplasty until access thrombosis or a surgical intervention that excludes the treated lesion from the access circuit. Examples include percutaneous treatments of either restenosis/occlusion of the previously treated lesion or a new arterial or venous outflow stenosis/occlusion (excluding access thrombosis). It ends with percutaneous thrombolysis/thrombectomy or simple surgical thrombectomy.	6 months
Secondary	Secondary patency	Secondary patency is defined as the interval after balloon angioplasty until the access is surgically declotted, revised or abandoned because of inability to treat the original lesion, choice of surgeon, transplant, loss to follow-up, etc. Examples include thrombolysis and percutaneous thrombectomy, as well as multiple repetitive treatments.	6 months
Secondary	Anatomic success	Anatomic success is defined as <30% residual stenosis diameter measured immediately after angioplasty.	Immediate post procedure
Secondary	Clinical success	Clinical success is defined as an improvement from baseline in the clinical or hemodynamic parameter (e.g., blood flow, venous pressures) that was the initial indicator of fistula/ graft dysfunction.	Immediate post procedure
Secondary	Procedural success	Procedural success is defined as the combination of anatomic success and clinical success.	Immediate post procedure