Stenosis of Arteriovenous Dialysis Fistula Clinical Trial
— DEBEFFOfficial title:
Drug Eluting Balloon for Early Fistula Failure Trial
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | King Faisal Specialist Hospital & Research Center | Riyadh |
Lead Sponsor | Collaborator |
---|---|
King Faisal Specialist Hospital & Research Center |
Saudi Arabia,
Asif A, Lenz O, Merrill D, Cherla G, Cipleu CD, Ellis R, Francois B, Epstein DL, Pennell P. Percutaneous management of perianastomotic stenosis in arteriovenous fistulae: results of a prospective study. Kidney Int. 2006 May;69(10):1904-9. — View Citation
Beathard GA, Arnold P, Jackson J, Litchfield T; Physician Operators Forum of RMS Lifeline. Aggressive treatment of early fistula failure. Kidney Int. 2003 Oct;64(4):1487-94. — View Citation
Beathard GA, Settle SM, Shields MW. Salvage of the nonfunctioning arteriovenous fistula. Am J Kidney Dis. 1999 May;33(5):910-6. — View Citation
Cassese S, Byrne RA, Ott I, Ndrepepa G, Nerad M, Kastrati A, Fusaro M. Paclitaxel-coated versus uncoated balloon angioplasty reduces target lesion revascularization in patients with femoropopliteal arterial disease: a meta-analysis of randomized trials. Circ Cardiovasc Interv. 2012 Aug 1;5(4):582-9. doi: 10.1161/CIRCINTERVENTIONS.112.969972. Epub 2012 Jul 31. — View Citation
Haskal ZJ, Trerotola S, Dolmatch B, Schuman E, Altman S, Mietling S, Berman S, McLennan G, Trimmer C, Ross J, Vesely T. Stent graft versus balloon angioplasty for failing dialysis-access grafts. N Engl J Med. 2010 Feb 11;362(6):494-503. doi: 10.1056/NEJMoa0902045. — View Citation
Katsanos K, Karnabatidis D, Kitrou P, Spiliopoulos S, Christeas N, Siablis D. Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access: 6-month interim results from a prospective randomized controlled trial. J Endovasc Ther. 2012 Apr;19(2):263-72. doi: 10.1583/11-3690.1. — View Citation
Lai CC, Fang HC, Tseng CJ, Liu CP, Mar GY. Percutaneous angioplasty using a paclitaxel-coated balloon improves target lesion restenosis on inflow lesions of autogenous radiocephalic fistulas: a pilot study. J Vasc Interv Radiol. 2014 Apr;25(4):535-41. doi: 10.1016/j.jvir.2013.12.014. Epub 2014 Feb 12. — View Citation
Patanè D, Giuffrida S, Morale W, L'Anfusa G, Puliatti D, Bisceglie P, Seminara G, Calcara G, Di Landro D, Malfa P. Drug-eluting balloon for the treatment of failing hemodialytic radiocephalic arteriovenous fistulas: our experience in the treatment of juxta-anastomotic stenoses. J Vasc Access. 2014 Sep-Oct;15(5):338-43. doi: 10.5301/jva.5000211. Epub 2014 Feb 10. — View Citation
Roy-Chaudhury P, Arend L, Zhang J, Krishnamoorthy M, Wang Y, Banerjee R, Samaha A, Munda R. Neointimal hyperplasia in early arteriovenous fistula failure. Am J Kidney Dis. 2007 Nov;50(5):782-90. — View Citation
Roy-Chaudhury P, Spergel LM, Besarab A, Asif A, Ravani P. Biology of arteriovenous fistula failure. J Nephrol. 2007 Mar-Apr;20(2):150-63. Review. — View Citation
Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schömig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabaté M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Jüni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. Review. — View Citation
Turmel-Rodrigues L, Mouton A, Birmelé B, Billaux L, Ammar N, Grézard O, Hauss S, Pengloan J. Salvage of immature forearm fistulas for haemodialysis by interventional radiology. Nephrol Dial Transplant. 2001 Dec;16(12):2365-71. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary patency | Patency of AVF without any additional procedures. Patency is defined as supporting HD with a pump speed of at least 300ml/min. | 6 months | No |
Secondary | Secondary Patency | Patency of AVF with additional procedures.Patency is defined as supporting HD with a pump speed of at least 300ml/min. | 6 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04399564 -
Temporary vs.Long Term Hemodialysis Catheter on Central Vein Stenosis
|
N/A | |
Terminated |
NCT02913274 -
Arteriovenous Fistulae: Drug-eluting Balloon Angioplasty
|
N/A | |
Recruiting |
NCT05232760 -
SUPER-DIALYSIS-Study: Supera Stent Interventions in Juxta-anastomotic (re)Stenosis
|
||
Not yet recruiting |
NCT03068845 -
Arteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Intervention Clinical Trial
|
Phase 3 | |
Completed |
NCT01544907 -
Prospective Randomized Trial Comparing DEB Versus Conventional PTA for the Treatment of Hemodialysis AVF or AVG Stenoses
|
N/A |