Clinical trial NCT04698512: MAgicTouch™ Intervention Leap for Dialysis Access (MATILDA) Trial
Official title: MAgic Touch™ Intervention Leap for Dialysis Access (MATILDA) Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dialysis Access Malfunction
End Stage Renal Failure on Dialysis
End Stage Renal Disease
Fistulas Arteriovenous
Stenosis
Keywords: Sirolimus coated balloon
Target lesion primary patency
Arterio-venous fistula
Outcome
Safety
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have received inpatient treatment (i.e. fistuloplasty) for their failing dialysis access at Singapore General Hospital

Brief summary: For patients with End Stage Renal Failure (ESRF), the surgical creation of an Autogenous Arteriovenous Fistula (AVF) or Autogenous Arteriovenous Graft (AVG) is the recognised standard for providing vascular access. A functioning dialysis vascular access is essential to facilitate hemodialysis (HD) treatment. Advantages include improved hemodialysis initiation time, improved dialysis quality, better maintenance of accesses and generally, better outcomes in patients. Unfortunately almost 50% of AVF and AVG fail after a median lifetime of 3 to 7 years and 12 to 18 months respectively. Vascular access dysfunction is a major cause of morbidity and hospitalisation for ESRF patients, costing the healthcare system USD 18 million globally. Venous stenosis and scarring are caused by trauma from surgical access creation when the circuit comes arterialized and from repeated percutaneous punctures from subsequent hemodialysis. This study is performed to evaluate Sirolimus-coated balloon efficacy and safety using MagicTouch™ Drug coated balloon catheter (Concept Medical Inc, Tampa, FL, US) on AVF patency with de novo and recurrent stenosis.


Eligibility criteria: Inclusion Criteria:

* Informed consent was obtained
* Patient aged ≥ 21 and ≤ 90 years
* Native AVF was created more than 2 months prior to index procedure and had undergone 10 or more haemodialysis sessions utilizing two needles
* Target lesion location had to be located between the anastomoses to the axillary-subclavian vein junction, as defined by insertion of the cephalic vein
* On initial fistulogram, target lesions stenosis had to be ≥50 on angiographic assessment and in keeping with the clinical indicator for intervention
* Stenosis had to \<12cm in length (to allow for potential treatment with one SCB (length 15cm) only
* Stenosis had to be initially treated successfully with a high-pressure plain balloon prior to SCB treatment as defined by:- (A) no clinically significant dissection (flow limiting) (B) no extravasation requiring treatment/stenting (C) residual stenosis ≤30% by angiographic measurement (D) Ability to completely efface the lesion waist using the pre-dilation balloon
* No more than one additional ("nontarget") lesion in the access circuit that had to be also successfully treated (≤30% residual stenosis) before drug elution. Separate lesion was defined by at least 3cm in distance from the target lesion.
* Reference vessel diameter 5mm-8mm

Exclusion Criteria:

* Women who were preganant, lactating, or planning on becoming pregnant during the study
* Subject had more than 2 lesions in the access circuit
* Subject had a secondary non-target lesion that could not be successfully treated
* Sepsis or active infection
* Asymptomatic target lesions
* A thrombosed access or an access with thrombosis treated ≤ 30 days prior to index procedure
* Surgical revision of the access site performed, planned or expected ≤ 3months before or after the index procedure
* Patients who were taking immunosuppressive therapy or are routinely taking ≥15 mg prednisone per day
* Currently participating in another investigational drug, biologic, or device study involving Sirolimus or paclitaxel
* Contraindication to Aspirin or Clopidogrel usage
* Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, or language barrier such that the subject is unable to give informed consent
* Uncooperative attitude or potential for non-compliance with the requirements of the protocol making study participation impractical
* Where final angioplasty treatment requires a stent or drug eluting balloon \>8mm in diameter
* Metastatic cancer or terminal medical condition
* Blood coagulation disorders
* Limited life expectancy (\<12 months)
* Allergy or other know contraindication to iodinated media contrast, heparin, or Sirolimus

Primary outcomes:
measure: Target Lesion Primary Patency
timeFrame: 3-months post op
measure: Target Lesion Primary Patency
timeFrame: 6-months post op
measure: Freedom from localised or systemic serious adverse events
timeFrame: 30 days post-op
Secondary outcomes:
measure: Access circuit patency
timeFrame: 3 and 6 months post op
measure: Procedural success
timeFrame: Day of operation
measure: Primary assisted patency
timeFrame: 3 and 6 months post op
measure: Number of open bypass revision surgery required to maintain access circuit primary patency
timeFrame: 3 and 6 months post op
measure: Secondary access patency
timeFrame: 3 and 6 months post-op
measure: Number of interventions required to maintain access circuit primary patency
timeFrame: 3 and 6 months post-op
measure: Event of mortality
timeFrame: 6 months post-op
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Tjun Yip Tang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee T, Roy-Chaudhury P. Advances and new frontiers in the pathophysiology of venous neointimal hyperplasia and dialysis access stenosis. Adv Chronic Kidney Dis. 2009 Sep;16(5):329-38. doi: 10.1053/j.ackd.2009.06.009.
citation: Pantelias K, Grapsa E. Vascular access today. World J Nephrol. 2012 Jun 6;1(3):69-78. doi: 10.5527/wjn.v1.i3.69.