Recurrent Stenoses in Arteriovenous Fistula (AVF) for Dialysis Access: CuttIng ballooN angioplaSTy Combined wITh Paclitaxel drUg coaTed Balloon Angioplasty, an observatIONal Clinical Study

Phase 2

Completed

• Conditions: Dialysis Access Malfunction
• Interventions: Device: Cutting balloon followed by paclitaxel coated balloon

• Registration Number: NCT05018962
• Lead Sponsor: Singapore General Hospital

Brief Summary

To determine if cutting balloon angioplasty combined with DEB angioplasty provides a higher primary patency after treatment of recurrent stenoses compared with cutting balloon angioplasty or angioplasty using DEB alone in the venous outflow AVFs. For cutting balloon angioplasty in venous stenosis, the primary patency after 12 months is 55-60% (9,16) and in recurrent stenoses up to 48%(10).

We hypothesise that DEB angioplasty after cutting balloon angioplasty leads to improved primary patency at 12 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-08
• Primary Completion: 2019-04-15
• Study Completion: 2020-03-18
• Status Verified: 2021-08
• Study First Submitted: 2021-08-22
• Study First Submitted QC: 2021-08-22
• Last Update Submitted: 2021-08-22
• Study First Posted: 2021-08-24
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Recurrent stenoses (within 1 year after angioplasty) in the venous outflow of AVFs for dialysis access (> 0.5cm from AV anastomosis up to cephalic arch)
• Successful guidewire crossing of target lesion
• ≥ 21 years old
• Informed and valid consent given.
• Patient willing and able to return for follow up .

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Exclusion Criteria

1. Thrombosed AVFs or occlusions in the access circuit
2. Significant cephalic arch (central perpendicular portion of the cephalic vein) or central vein stenoses.
3. > 3 stenosed segments (lesions are considered separate if they are separated by at least 2 cm normal vessel.)
4. Only potential target lesion located in cephalic arch, central veins or anastomotic lesions.
5. Only de novo stenoses identifiable as target lesion.
6. Target lesion resistant to cutting balloon angioplasty (>30% residual stenosis with incomplete effacement of the lesion during cutting balloon angioplasty)
7. Target lesion not treatable with the available sizes of cutting balloon (4-7mm) and drug eluting balloon (up to 8mm) so native reference vessel <3 mm or need for DEB balloon >8mm.
8. Lesion in excess of 8 cm
9. Unable to take dual antiplatelet therapy for 1 month and/or aspirin for 6 months
10. Coagulopathy (PT or PTT >1.5 times the median of normal range) or thrombocytopenia (platelet count <50,000 /μL) that cannot be managed adequately with periprocedural transfusion.
11. Patient on Warfarin.
12. Known allergy to iodinated contrast that cannot be managed adequately with pre-procedure medication.
13. Allergy / contraindication to dual anti-platelet therapy (aspirin and clopidogrel or ticlopidine) or paclitaxel.
14. Acute infection over proposed puncture site.
15. Women who are breastfeeding, pregnant or planning on becoming pregnant during study.
16. Participant with medical conditions, which in the opinion of the investigator may cause non-compliance with protocol.
17. Currently participating in an investigational drug, biologic or device trial that may have an impact on the dialysis access or previous enrolment in this study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cutting balloon followed by paclitaxel coated balloon	Cutting balloon followed by paclitaxel coated balloon	-

Primary Outcome Measures

Name	Time	Method
Target lesion primary patency	1 year	Target lesion primary patency

Secondary Outcome Measures

Name	Time	Method
Circuit primary patency	1 year	Circuit primary patency
Target lesion primary assisted patency	1 year

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore