Drug Eluting Balloon for Early Fistula Failure Trial

NCT02632955 | Unknown

• 1 other identifier: 2151 054
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stenosis of Arteriovenous Dialysis Fistula

Keywords

arteriovenous fistula; hemodialysis; drug coated balloon

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Secondary Patency

  6 months

Study Arms (2)

Drug Eluting Balloon

EXPERIMENTAL

After pre dilation of the lesion with regular angioplasty balloon, drug coated balloon Lutonix(R) by Bard Inc. will be introduced over the lesion as quickly as possible. Lutonix is a paclitaxel coated balloon which delivers the drug locally. The diameter of the drug coated balloon will be same as the diameter of the largest balloon used for pre dilation. Drug coated balloon will be inflated not exceeding the rated burst pressure. The minimum inflation time will be 1 minute.

Drug: Drug Eluting Balloon

Regular Angioplasty

SHAM COMPARATOR

After predilation of the lesion with regular balloon, the same balloon will be reintroduced without the drug to be inflated for a minimum of 1 minute. This angioplasty will not deliver any local drug.

Procedure: Regular angioplasty

Interventions

Drug Eluting Balloon DRUG

After pre dilation of the lesion with regular angioplasty balloon, drug coated balloon Lutonix(R) by Bard Inc. will be introduced over the lesion as quickly as possible. Lutonix is a paclitaxel coated balloon which delivers the drug locally. The diameter of the drug coated balloon will be same as the diameter of the largest balloon used for pre dilation. Drug coated balloon will be inflated not exceeding the rated burst pressure. The minimum inflation time will be 1 minute.

Also known as: Lutonix drug eluting Balloon angioplasty

Drug Eluting Balloon

Regular angioplasty PROCEDURE

After predilation of the lesion with regular balloon, the same balloon will be reintroduced without the drug to be inflated for a minimum of 1 minute. This angioplasty will not deliver any local drug.

Also known as: Percutaneous balloon angioplasty

Regular Angioplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Patients with EFF
• Stenosis anywhere in the AVF being the only identifiable cause of EFF.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital & Research Center

Riyadh, 11211, Saudi Arabia

RECRUITING

Related Publications (12)

• 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. doi: 10.1046/j.1523-1755.2003.00210.x.

  PMID: 12969170 BACKGROUND

• 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.

  PMID: 17514619 BACKGROUND

• Beathard GA, Settle SM, Shields MW. Salvage of the nonfunctioning arteriovenous fistula. Am J Kidney Dis. 1999 May;33(5):910-6. doi: 10.1016/s0272-6386(99)70425-7.

  PMID: 10213648 BACKGROUND

• Turmel-Rodrigues L, Mouton A, Birmele B, Billaux L, Ammar N, Grezard O, Hauss S, Pengloan J. Salvage of immature forearm fistulas for haemodialysis by interventional radiology. Nephrol Dial Transplant. 2001 Dec;16(12):2365-71. doi: 10.1093/ndt/16.12.2365.

  PMID: 11733628 BACKGROUND

• 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. doi: 10.1053/j.ajkd.2007.07.019.

  PMID: 17954291 BACKGROUND

• 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. doi: 10.1038/sj.ki.5000358.

  PMID: 16557220 BACKGROUND

• 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.

  PMID: 20147715 BACKGROUND

• Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate 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, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5.

  PMID: 17869634 BACKGROUND

• 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.

  PMID: 22851526 BACKGROUND

• 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.

  PMID: 22545894 BACKGROUND

• Patane 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.

  PMID: 24531999 BACKGROUND

• 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.

  PMID: 24529550 BACKGROUND

MeSH Terms

Conditions

Arteriovenous Fistula

Interventions

Angioplasty, Balloon, Coronary

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Angioplasty, Balloon; Angioplasty; Catheterization; Therapeutics; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Investigative Techniques

Study Officials

• Naveed U Haq, MD, FASN

  King Faisal Specialist Hospital & Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naveed U Haq, MD, FASN

CONTACT

+966 11 4427492; nulhaq@kfshrc.edu.sa

Muhammad Azhar, MD

CONTACT

+966 11 4427492; mazhar@kfshrc.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Dialysis Access & Interventional Nephrology Program

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 17, 2015
• Study Start: December 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 4, 2016

Record last verified: 2016-10

Locations

SA (1)