MAgicTouch™ Intervention Leap for Dialysis Access (MATILDA) Trial

NCT04698512 | Completed

• 1 other identifier: MATILDA
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  30 days post-op

Secondary Outcomes (7)

• Access circuit patency

  3 and 6 months post op

• Procedural success

  Day of operation

• Primary assisted patency

  3 and 6 months post op

• 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

Study Arms (1)

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

Interventions

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

Arteriovenous Fistuloplasty with MagicTouch™ Balloon

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169856, Singapore

Location

Related Publications (2)

• 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.

  PMID: 19695501 BACKGROUND

• Pantelias K, Grapsa E. Vascular access today. World J Nephrol. 2012 Jun 6;1(3):69-78. doi: 10.5527/wjn.v1.i3.69.

  PMID: 24175244 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriovenous Fistula; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Study Officials

• Tjun Yip Tang

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: January 7, 2021
• Study Start: May 21, 2019
• Primary Completion: January 16, 2020
• Study Completion: January 30, 2021
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)