Status:
COMPLETED
MAgicTouch™ Intervention Leap for Dialysis Access (MATILDA) Trial
Lead Sponsor:
Singapore General Hospital
Conditions:
Dialysis Access Malfunction
End Stage Renal Failure on Dialysis
Eligibility:
All Genders
21-90 years
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 va...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 21 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 30 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04698512
Start Date
May 21 2019
End Date
January 30 2021
Last Update
March 17 2021
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, 169856