NCT01928498

Brief Summary

The purpose of this study is to evaluate the effectiveness of paclitaxel-coated balloon catheter to prevent restenosis after PTA (percutaneous transluminal angioplasty) of hemodialysis access (HA) in comparison with the uncoated PTA balloon catheter.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2020

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

6.3 years

First QC Date

August 21, 2013

Last Update Submit

January 18, 2021

Conditions

Arteriovenous FistulaeArteriovenous Graft

Keywords

arteriovenous fistulaearteriovenous graftrestenosisangioplastydrug eluting balloon

Outcome Measures

Primary Outcomes (1)

  • Late lumen loss (LLL) at 6 months after PTA (percutaneous transluminal angioplasty)

    Comparison of the mean LLL (late lumen loss) in patients in the two trial arms (DEB vs plain PTA) evaluated by quantitative angiography at six months after PTA. LLL is defined as the difference between the MLD (minimum lumen diameter) immediately after balloon angioplasty and the MLD at follow-up

    6 months

Secondary Outcomes (4)

  • The angiographic percentage of diameter stenosis and the incidence of angiographic binary restenosis rate (≥50% of the diameter of the reference-vessel segment)

    6 months

  • Change of HA flow

    Before angioplasty, week 1, month 1or month 3

  • The rate of HA failure

    3 months

  • Drug eluting balloon safety

    3 months

Study Arms (2)

Paclitaxel Eluting Balloon

EXPERIMENTAL

Paclitaxel Eluting Balloon Angioplasty

Device: Paclitaxel Eluting Balloon Angioplasty

Conventional uncoated balloon

ACTIVE COMPARATOR

Percutaneous Transluminal Angioplasty (PTA)

Device: Percutaneous Transluminal Angioplasty (PTA)

Interventions

Paclitaxel Eluting Balloon AngioplastyDEVICE
Also known as: Passeo-18 Lux
Paclitaxel Eluting Balloon
Percutaneous Transluminal Angioplasty (PTA)DEVICE
Also known as: Passeo-18
Conventional uncoated balloon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical or hemodynamic evidence of HA dysfunction according to the clinician's judgment
  • Patients with AVF (arteriovenous fistulae)or AVG (arteriovenous graft) located in the forearm or upper arm and is \> 3 months old
  • Minimum age of 18 years and written informed consent
  • Target lesion stenosis is \<3.0 cm in length and \>50% in luminal diameter reduction
  • Maximum of two secondary lesions (stenoses) if the following criteria are satisfied: The secondary lesion is located in the graft or peripheral veins, the secondary lesion is \<3.0 cm in length and located \>1.0 cm away from the target lesion, the secondary lesion is \>50% luminal reduction compared to the reference vessel diameter
  • Reference vessel diameter between 4 to 7 mm
  • The HA must not be thrombosed and the lesion can be crossed with guide wire before angioplasty
  • Lesion site: from 2 cm above the arterial anastomosis to the superior vena cava
  • Restenotic lesion (previously treated by PTA or stent) or de novo lesion

You may not qualify if:

  • Contraindication to angiography or PTA
  • Intervention of the HA circuit within the past 30 days
  • Systemic infection or a local infection associated with the graft
  • The patient is pregnant
  • Patient is enrolled in another investigational study.
  • Life expectancy \< 12 months
  • History of severe allergic reaction to contrast media or to paclitaxel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Charles-Lemoyne

Longueuil, Quebec, Canada

Location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Centre Hospitalier de l'université de Montréal-CHUM

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Interventions

Angioplasty

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • Éric Therasse, MD

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2013

First Posted

August 26, 2013

Study Start

October 1, 2013

Primary Completion

January 13, 2020

Study Completion

August 27, 2020

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

CA(3)