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Completed

NCT Number: NCT04698512

MAgicTouch™ Intervention Leap for Dialysis Access (MATILDA) Trial

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.

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Key information

Conditions

Dialysis Access Malfunction Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Constriction, Pathologic Disease Attributes End Stage Renal Disease End Stage Renal Failure on Dialysis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Fistulas Arteriovenous Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Stenosis Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Singapore General Hospital

Singapore, 169856

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AVFistuloplasty with Sirolimus coated balloon

Device

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

Primary outcomes

  1. Target Lesion Primary Patency

    Time frame: 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

  2. Target Lesion Primary Patency

    Time frame: 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

  3. Freedom from localised or systemic serious adverse events

    Time frame: 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 outcomes

  1. Access circuit patency

    Time frame: 3 and 6 months post op

    Lack of stenosis in any region of the AVF circuit requiring intervention

  2. Procedural success

    Time frame: 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.

  3. Primary assisted patency

    Time frame: 3 and 6 months post op

    Lack of access circuit thrombosis requiring thrombolysis

  4. Number of open bypass revision surgery required to maintain access circuit primary patency

    Time frame: 3 and 6 months post op

  5. Secondary access patency

    Time frame: 3 and 6 months post-op

    Lack of dialysis access abandonment

  6. Number of interventions required to maintain access circuit primary patency

    Time frame: 3 and 6 months post-op

  7. Event of mortality

    Time frame: 6 months post-op

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Registry information

Official study title

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

Acronym: MATILDA

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jan 7, 2021
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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