Dialysis Access MalfunctionMATILDANCT04698512
MAgicTouch™ Intervention Leap for Dialysis Access (MATILDA) Trial
An observational study of Dialysis Access Malfunction and End Stage Renal Failure on Dialysis, run by Singapore General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Dialysis Access Malfunction, End Stage Renal Failure on Dialysis, End Stage Renal Disease
- What is being tested?
- AVFistuloplasty with Sirolimus coated balloon
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteSingapore
- Study dates
- 21 May 2019to 30 Jan 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have received inpatient treatment (i.e. fistuloplasty) for their failing dialysis access at Singapore General Hospital
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dialysis Access Malfunction, End Stage Renal Failure on Dialysis, End Stage Renal Disease, Fistulas Arteriovenous, Stenosis
- Being tested
- AVFistuloplasty with Sirolimus coated balloon
- Keywords
- Sirolimus coated balloon, Target lesion primary patency, Arterio-venous fistula, Outcome, Safety
- Medical subject headings
- Kidney Failure, Chronic, Arteriovenous Fistula, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVFistuloplasty with Sirolimus coated balloonDevice
After an initial fistulogram, the lesion will first be predicated with standard high pressure balloon, followed by MagicTouch™ Sirolimus drug coated balloon
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AVFistuloplasty with Sirolimus coated balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Primary Patency
No need for clinically driven reintervention of target lesion, no access thrombosis and no significant restenosis (lumen diameter <2.7mm) on duplex ultrasound
Measured: 3-months post op
Target Lesion Primary Patency
No need for clinically driven reintervention of target lesion, no access thrombosis and no significant restenosis (lumen diameter <2.7mm) on duplex ultrasound
Measured: 6-months post op
Freedom from localised or systemic serious adverse events
Include life-threatening events or those resulting in death, requiring hospitalisation, resulting in permanent disability, or requiring intervention to prevent permanent impairment
Measured: 30 days post-op
Secondary outcomes (7)
Access circuit patency
Lack of stenosis in any region of the AVF circuit requiring intervention
Measured: 3 and 6 months post op
Procedural success
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.
Measured: Day of operation
Primary assisted patency
Lack of access circuit thrombosis requiring thrombolysis
Measured: 3 and 6 months post op
Number of open bypass revision surgery required to maintain access circuit primary patency
Measured: 3 and 6 months post op
Secondary access patency
Lack of dialysis access abandonment
Measured: 3 and 6 months post-op
Number of interventions required to maintain access circuit primary patency
Measured: 3 and 6 months post-op
Event of mortality
Measured: 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start21 May 2019
- Primary completion16 Jan 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dialysis Access MalfunctionStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tjun Yip Tang, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698512
- Sponsor's protocol ID
- MATILDA
- Acronym
- MATILDA
- Status last verified
- Mar 2021
- First submitted
- 28 Dec 2020
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19695501Pantelias K, Grapsa E. Vascular access today. World J Nephrol. 2012 Jun 6;1(3):69-78. doi: 10.5527/wjn.v1.i3.69.
PubMed 24175244
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAgic Touch™ Intervention Leap for Dialysis Access (MATILDA) Trial
- ClinicalTrials.gov ID
- NCT04698512
- Acronym / sponsor ID
- MATILDA / MATILDA
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 21 May 2019 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arteriovenous Fistuloplasty with MagicTouch™ Balloon | – | Device: AVFistuloplasty with Sirolimus coated balloonPatients 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. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have received inpatient treatment (i.e. fistuloplasty) for their failing dialysis access at Singapore General Hospital
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVFistuloplasty with Sirolimus coated balloonAfter an initial fistulogram, the lesion will first be predicated with standard high pressure balloon, followed by MagicTouch™ Sirolimus drug coated balloon | Device | Arteriovenous Fistuloplasty with MagicTouch™ Balloon |
Primary outcome
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
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
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
7 secondary outcomes
Access circuit patency
Time frame: 3 and 6 months post op
Procedural success
Time frame: Day of operation
Primary assisted patency
Time frame: 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
Secondary access patency
Time frame: 3 and 6 months post-op
Number of interventions required to maintain access circuit primary patency
Time frame: 3 and 6 months post-op
Event of mortality
Time frame: 6 months post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Background: PubMed 19695501Lee 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.
- Background: PubMed 24175244Pantelias K, Grapsa E. Vascular access today. World J Nephrol. 2012 Jun 6;1(3):69-78. doi: 10.5527/wjn.v1.i3.69.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tjun Yip Tang principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dialysis Access Malfunction and End Stage Renal Failure on Dialysis, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Primary Patency (time frame: 3-months post op). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04698512, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.