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

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.

Study Overview

• Status: Completed
• Conditions: Dialysis Access Malfunction
• Intervention / Treatment: Device: Cutting balloon followed by paclitaxel coated balloon

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 .

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cutting balloon followed by paclitaxel coated balloon	Device: Cutting balloon followed by paclitaxel coated balloon; Cutting balloon followed by paclitaxel coated balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion primary patency	Target lesion primary patency	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circuit primary patency	Circuit primary patency	1 year
Target lesion primary assisted patency		1 year

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Collaborators: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2017
• Primary Completion (Actual): April 15, 2019
• Study Completion (Actual): March 18, 2020

Study Registration Dates

• First Submitted: August 22, 2021
• First Submitted That Met QC Criteria: August 22, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 22, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Paclitaxel coated balloon; Cutting balloon; Recurrent stenosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Constriction, Pathologic; Arteriovenous Fistula; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: 2017/2046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes