MAgicTouch™ Intervention Leap for Dialysis Access (MATILDA) Trial

End Stage Renal Disease Clinical Trial

— MATILDA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04698512
• Other study ID #: MATILDA
• Status: Completed
• Start date: May 21, 2019
• Est. completion date: January 30, 2021

Study information

• Verified date: March 2021
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 30, 2021
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Dialysis Access Malfunction
• End Stage Renal Disease
• End Stage Renal Failure on Dialysis
• Fistula
• Fistulas Arteriovenous
• Kidney Failure, Chronic
• Stenosis

Intervention

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

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

References & 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. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Access circuit patency	Lack of stenosis in any region of the AVF circuit requiring intervention	3 and 6 months post op
Secondary	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.	Day of operation
Secondary	Primary assisted patency	Lack of access circuit thrombosis requiring thrombolysis	3 and 6 months post op
Secondary	Number of open bypass revision surgery required to maintain access circuit primary patency		3 and 6 months post op
Secondary	Secondary access patency	Lack of dialysis access abandonment	3 and 6 months post-op
Secondary	Number of interventions required to maintain access circuit primary patency		3 and 6 months post-op
Secondary	Event of mortality		6 months post-op