NCT04263116

Balloon-Assisted Maturation of Autogenous Arteriovenous Fistulae

Completed NA Last updated 10 February 2020

What this trial tests

NA trial testing Balloon Assisted Maturation in Hemodialysis Access Failure in 300 participants. Completed in 30 May 2019.

Timeline

25 July 2017

Primary endpoint
25 May 2019

30 May 2019

Quick facts

Lead sponsor	Mansoura University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	300
Start date	25 July 2017
Primary completion	25 May 2019
Estimated completion	30 May 2019
Sites	1 location across Egypt

Drugs / interventions tested

• Balloon Assisted Maturation

Conditions studied

• Hemodialysis Access Failure — all drugs for Hemodialysis Access Failure →

Sponsor

Mansoura University

Who can join

18 and older, any sex, with Hemodialysis Access Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: There are several studies that document the safety and efficacy of the balloon-assisted maturation (BAM) technique. Ultimately, there are also studies that report its possible negative consequences such as fibrosis and restenosis of venous outflow, leading to malfunctioning arteriovenous fistula (AVF). Thus, in an effort to increase the number of primary AVFs, shorten maturation times, and reduce the number of indwelling catheters, we ascertain the BAM technique within this study to optimize access care and maximize use of AVFs. The balloon assisted maturation approach specifically and aggressively dilates the entire usable segment of the AVF.

Methods: This is a randomized prospective study conducted in the department of vascular surgery, Mansoura University Hospitals, including patients with hemodialysis access creation between June 2017 and May 2019. Three hundred patients were recruited from a total of 648 primary AVF creation cases. Patients were divided into two groups; Group (A) Balloon assisted maturation (BAM) (n=157) 52.3 % technique had been done while in the other Group (B) the usual maneuver was used (NO BAM) (n=143) 47.7%. Preoperative duplex was done for all cases to assess suitability. Intraoperative venography was the initial step following surgical exposure of the assigned veins to ascertain continuity and unlimited flow of the superficial vein. Balloon dilatation by 1 mm larger than the size of the vein, sparing the spatulated end of the vein followed by post-dilatation venography to reveal any injury and assess the success of dilatation process. All cases were completed as an end to side anastomosis. Patients were followed clinically and radiologically at regular visits in the 2nd, 4th and 6th week post-procedure, assessing the flow rate, vein depth and diameter via duplex US examination.

Results: Patients age ranged from 19 to 89 (mean 51.17 ±15.5) years. The average maturation time was 3.7 weeks (SD ± 1.3 w) and 5.91 weeks (SD ± 2.2 w) for the BAM and non-BAM groups, respectively. Eighty-seven cases (88.7 %) with a pre-operative vein diameter of 3 mm or less, that underwent BAM showed early maturation and started dialysis within 2-4 weeks (68 cases 70%). On the other hand, 28 cases (45.2%) with a vein diameter equal or less than 3 mm in the NO BAM group failed to get mature. Both successful functional maturation (95%) and complication rates (9.6 %) were higher among cases of the BAM group compared to 80.4% maturation rate and 5 % complication in the NO BAM group. The higher complication rate may be attributed to the large number of cases.

Conclusion: Balloon-assisted maturation has a pivotal role to help the dialysis society meet the goals of the Fistula First Initiative; It can achieve an accelerated functional maturation of AVF in cases of small caliber veins, with access to early dialysis, thus decreasing the indwelling catheter-related complications.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.