MAgicTouch™ Intervention Leap for Dialysis Access (MATILDA) Trial

Sponsor

Singapore General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04698512

Collaborator

(none)

Enrollment

Location

20.4

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dialysis Access Malfunction End Stage Renal Failure on Dialysis End Stage Renal Disease Fistulas Arteriovenous Stenosis	Device: AVFistuloplasty with Sirolimus coated balloon

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

35 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

MAgic Touch™ Intervention Leap for Dialysis Access (MATILDA) Trial

Actual Study Start Date :

May 21, 2019

Actual Primary Completion Date :

Jan 16, 2020

Actual Study Completion Date :

Jan 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Arteriovenous Fistuloplasty with MagicTouch™ Balloon Patients above the age of 21 that have undergone AVF / AVG fistuloplasty with MagicTouch™ at Singapore General Hospital will be included in the study and followed up post-op for 12 months. Patients will be treated and followed-up following standard clinical care pathways.	Device: AVFistuloplasty with Sirolimus coated balloon After an initial fistulogram, the lesion will first be predicated with standard high pressure balloon, followed by MagicTouch™ Sirolimus drug coated balloon

Arm

Intervention/Treatment

Arteriovenous Fistuloplasty with MagicTouch™ Balloon

Patients above the age of 21 that have undergone AVF / AVG fistuloplasty with MagicTouch™ at Singapore General Hospital will be included in the study and followed up post-op for 12 months. Patients will be treated and followed-up following standard clinical care pathways.

Device: AVFistuloplasty with Sirolimus coated balloon

After an initial fistulogram, the lesion will first be predicated with standard high pressure balloon, followed by MagicTouch™ Sirolimus drug coated balloon

Outcome Measures

Primary Outcome Measures

Target Lesion Primary Patency [3-months post op]
No need for clinically driven reintervention of target lesion, no access thrombosis and no significant restenosis (lumen diameter <2.7mm) on duplex ultrasound
Target Lesion Primary Patency [6-months post op]
No need for clinically driven reintervention of target lesion, no access thrombosis and no significant restenosis (lumen diameter <2.7mm) on duplex ultrasound
Freedom from localised or systemic serious adverse events [30 days post-op]
Include life-threatening events or those resulting in death, requiring hospitalisation, resulting in permanent disability, or requiring intervention to prevent permanent impairment

Secondary Outcome Measures

Access circuit patency [3 and 6 months post op]
Lack of stenosis in any region of the AVF circuit requiring intervention
Procedural success [Day of operation]
Defined as technical success with at least one indicator of hemodynamic or clinical success. I.e. no conduit rupture during any of the procedures requiring bailout stenting.
Primary assisted patency [3 and 6 months post op]
Lack of access circuit thrombosis requiring thrombolysis
Number of open bypass revision surgery required to maintain access circuit primary patency [3 and 6 months post op]
Secondary access patency [3 and 6 months post-op]
Lack of dialysis access abandonment
Number of interventions required to maintain access circuit primary patency [3 and 6 months post-op]
Event of mortality [6 months post-op]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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