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

Primary Purpose

Dialysis Access Malfunction

Status
Completed
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Cutting balloon followed by paclitaxel coated balloon
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dialysis Access Malfunction focused on measuring Paclitaxel coated balloon, Cutting balloon, Recurrent stenosis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Singapore General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cutting balloon followed by paclitaxel coated balloon

Arm Description

Outcomes

Primary Outcome Measures

Target lesion primary patency
Target lesion primary patency

Secondary Outcome Measures

Circuit primary patency
Circuit primary patency
Target lesion primary assisted patency

Full Information

First Posted
August 22, 2021
Last Updated
August 22, 2021
Sponsor
Singapore General Hospital
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05018962
Brief Title
Recurrent Stenoses in Arteriovenous Fistula (AVF) for Dialysis Access: CuttIng ballooN angioplaSTy Combined wITh Paclitaxel drUg coaTed Balloon Angioplasty, an observatIONal Clinical Study
Acronym
INSTITUTION
Official Title
Recurrent Stenoses in Arteriovenous Fistula (AVF) for Dialysis Access: CuttIng ballooN angioplaSTy Combined wITh Paclitaxel drUg coaTed Balloon Angioplasty, an observatIONal Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 8, 2017 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
March 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
Boston Scientific Corporation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dialysis Access Malfunction
Keywords
Paclitaxel coated balloon, Cutting balloon, Recurrent stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cutting balloon followed by paclitaxel coated balloon
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Cutting balloon followed by paclitaxel coated balloon
Intervention Description
Cutting balloon followed by paclitaxel coated balloon
Primary Outcome Measure Information:
Title
Target lesion primary patency
Description
Target lesion primary patency
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Circuit primary patency
Description
Circuit primary patency
Time Frame
1 year
Title
Target lesion primary assisted patency
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Thrombosed AVFs or occlusions in the access circuit Significant cephalic arch (central perpendicular portion of the cephalic vein) or central vein stenoses. > 3 stenosed segments (lesions are considered separate if they are separated by at least 2 cm normal vessel.) Only potential target lesion located in cephalic arch, central veins or anastomotic lesions. Only de novo stenoses identifiable as target lesion. Target lesion resistant to cutting balloon angioplasty (>30% residual stenosis with incomplete effacement of the lesion during cutting balloon angioplasty) 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. Lesion in excess of 8 cm Unable to take dual antiplatelet therapy for 1 month and/or aspirin for 6 months 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. Patient on Warfarin. Known allergy to iodinated contrast that cannot be managed adequately with pre-procedure medication. Allergy / contraindication to dual anti-platelet therapy (aspirin and clopidogrel or ticlopidine) or paclitaxel. Acute infection over proposed puncture site. Women who are breastfeeding, pregnant or planning on becoming pregnant during study. Participant with medical conditions, which in the opinion of the investigator may cause non-compliance with protocol. 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.
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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