Drug Eluting Balloon for Early Fistula Failure Trial

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Hemodialysis (HD) remains the most prevalent form of renal replacement therapy (RRT) for patients with End Stage Renal Disease (ESRD). Loss and dysfunction of vascular access is a significant contributor to morbidity in ESRD patients on HD. The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines suggest that all ESRD patients should initiate dialysis with a functioning permanent vascular access with arteriovenous fistulas (AVF) preferred over arteriovenous grafts (AVG). Central venous catheters (CVC) are the least preferred vascular access for HD due to the complications associated with them. Despite these recommendations, up to 80% patients start dialysis with a CVC. One of the reasons for low AVF rates is early fistula failure (EFF). The most important causes for EFF amenable to intervention is stenosis anywhere in the circuit. Endovascular approach has shown a high rate of technical success in the treatment of stenotic lesions related to HD arteriovenous access. Percutaneous balloon angioplasty (PBA) is considered the treatment of choice for these lesions. Despite good technical and immediate success PBA has poor long term outcomes with recurrence rates of 60-70% at 6 months. One of the reasons could be the damage caused by angioplasty itself leading to intima-media rupture promoting the cascade of events leading to further development of neo intimal hyperplasia (NIH). Recently the use of covered stents at the time of angioplasty has shown better patency rates at 6 months but still not optimal. Lately the development of drug eluting stents and drug eluting balloons (DEB) have shown considerable advantage in clinical trials related to coronary and peripheral arterial disease angioplasty. In a randomized control trial, the researchers are planning to assess the efficacy of DEB angioplasty as compared to standard PBA in AVF's with EFF.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Faisal Specialist Hospital & Research Center

Criteria

Inclusion Criteria:

• Age >18 years

• Patients with EFF

• Stenosis anywhere in the AVF being the only identifiable cause of EFF.

Exclusion Criteria:

• Patients with AVF which is deeper than 0.8cm from the skin.

• AVF which is tortuous and lacks adequate straight segment for cannulation with 2 needles.

• Patients with allergy to paclitaxel

• Patients on anti-coagulation and those with bleeding disorders.

• Severe thrombocytopenia i.e platelet count< 50,000.

• Life expectancy less than 12 months.

• Documented severe contrast allergy.

• Inability to come for timely and adequate follow up.

• Patients undergoing transplantation work up and expected to be transplanted within 6 months.

• EFF secondary to accessory veins or causes other than stenosis.