Status:
UNKNOWN
Use of Implanting the Biotronik Passeo-18 Lux Drug Coated Balloon to Treat Failing Haemodialysis Arteriovenous Fistulas and Grafts.
Lead Sponsor:
Singapore General Hospital
Conditions:
Arterio-venous Fistula
Dialysis Access Malfunction
Eligibility:
All Genders
21-90 years
Brief Summary
The most common problem with haemodialysis arteriovenous fistulas (AVF) and arterio-venous grafts (AVG) is stenosis, which can lead to inadequate dialysis, and eventual access thrombosis. Conventional...
Eligibility Criteria
Inclusion
- Patient aged ≥21 years and ≤90 years
- Native AVF was created more than 2 months prior to the index procedure and had undergone 10 or more hemodialysis sessions utilizing 2 needles
- Target lesion location had to be located between the anastomosis to the axillary-subclavian vein junction, as defined by insertion of the cephalic vein.
- On initial fistulogram, target lesion stenosis had to be \>50% on angiographic assessment and in keeping with the clinical indicator for intervention
- Stenosis had to be \< 10cm in length to allow for potential treatment with one PCB (length 12 cm) only
- Stenosis had to be initially treated successfully with a high-pressure plain balloon prior to PCB treatment as defined by:
- No clinically significant dissection
- No extravasation requiring treatment/stenting
- Residual stenosis ≤20% by angiographic measurement
- Ability to completely efface the lesion waist using the pre-dilation balloon
- No more than one additional ("nontarget") lesions in the access circuit that had to be also successfully treated (≤30% residual stenosis) before drug elution. Separate lesion was defined by at least 3 cm in distance from the target lesion.
- Reference vessel diameter 4mm - 8mm
Exclusion
- Women who were pregnant, lactating, or planning on becoming pregnant during the study
- Subject had more than two 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 the index procedure
- Surgical revision of the access site performed, planned or expected ≤ 3 months before or after the index procedure
- Patients who were taking immunosuppressive therapy or are routinely taking ≥ 15 mg of prednisone per day;
- Currently participating in an 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 known contraindication to iodinated media contrast, heparin or paclitaxel
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04381754
Start Date
June 1 2020
End Date
June 1 2022
Last Update
May 11 2020
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, 169856