MAgicTouch™ Intervention Leap for Dialysis Access (MATILDA) Trial (MATILDA)

March 16, 2021 updated by: Singapore General Hospital

MAgic Touch™ 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169856
        • Singapore General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3-months post op
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
6-months post op
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
30 days post-op

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Access circuit patency
Time Frame: 3 and 6 months post op
Lack of stenosis in any region of the AVF circuit requiring intervention
3 and 6 months post op
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.
Day of operation
Primary assisted patency
Time Frame: 3 and 6 months post op
Lack of access circuit thrombosis requiring thrombolysis
3 and 6 months post op
Number of open bypass revision surgery required to maintain access circuit primary patency
Time Frame: 3 and 6 months post op
3 and 6 months post op
Secondary access patency
Time Frame: 3 and 6 months post-op
Lack of dialysis access abandonment
3 and 6 months post-op
Number of interventions required to maintain access circuit primary patency
Time Frame: 3 and 6 months post-op
3 and 6 months post-op
Event of mortality
Time Frame: 6 months post-op
6 months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Singapore General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MATILDA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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