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

NCT05018962 | Completed Phase 2 FDA Device

• 1 other identifier: 2017/2046
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Dialysis Access Malfunction

Keywords

Paclitaxel coated balloon; Cutting balloon; Recurrent stenosis

Outcome Measures

Primary Outcomes (1)

• Target lesion primary patency

  Target lesion primary patency

  1 year

Secondary Outcomes (2)

• Circuit primary patency

  1 year

• Target lesion primary assisted patency

  1 year

Study Arms (1)

Cutting balloon followed by paclitaxel coated balloon

EXPERIMENTAL

Device: Cutting balloon followed by paclitaxel coated balloon

Interventions

Cutting balloon followed by paclitaxel coated balloon DEVICE

Cutting balloon followed by paclitaxel coated balloon

Cutting balloon followed by paclitaxel coated balloon

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singapore General Hospital: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: August 24, 2021
• Study Start: September 8, 2017
• Primary Completion: April 15, 2019
• Study Completion: March 18, 2020
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)