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Atherectomy and Drug Coated Balloon for the Treatment of Arterio-Venous Graft Stenosis

Primary Purpose

Dysfunctional Arterial-venous Grafts

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Atherectomy and balloon angioplasty
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysfunctional Arterial-venous Grafts

Eligibility Criteria

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

Inclusion Criteria:

  • Male or non-pregnant, non-breastfeeding female ≥18 years of age;
  • Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits;
  • Target lesion must be a mature arteriovenous graft presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines;
  • Subject has a target lesion at the venous anastomosis of the AVG;
  • Successful crossing of the stenosis;
  • Each lesion length is ≤20mm, which may include tandem lesions that are ≤20mm apart

Exclusion Criteria:

  • Subject is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this study;
  • Subject has a non-controllable allergy to contrast;
  • Subject has more than 3 lesions in the access circuit requiring intervention;
  • Target lesion diameter >10mm;
  • A thrombosed access or an access with a thrombosis treated ≤30 days prior to the index procedure;
  • Prior surgical interventions of the access site ≤30 days before the index procedure;
  • Target lesion is located within a bare metal or covered stent.

Sites / Locations

  • University Health NetworkRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dysfunction AV graft

Arm Description

Dysfunctional AV graft stenosis treated with atherectomy and drug coated balloon angioplasty

Outcomes

Primary Outcome Measures

Target Lesion Primary Patency (TLPP) through 6 months
50% re-stenosis of the target lesion

Secondary Outcome Measures

Full Information

First Posted
November 9, 2020
Last Updated
March 10, 2021
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT04627051
Brief Title
Atherectomy and Drug Coated Balloon for the Treatment of Arterio-Venous Graft Stenosis
Official Title
A Prospective, Single-Centre Study Investigating the Clinical Use and Safety of the Jetstream Atherectomy With Drug Coated Balloon (Ranger) for the Treatment of Dysfunctional Arterio-Venous Graft Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 12, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This single-centre, single-arm, prospective study will enroll 30 subjects presenting with clinical and hemodynamic abnormalities in arteriovenous graft (AVG) in the arm. Subjects will be treated with the Jetstream™ atherectomy device and Ranger™ Drug Coated Balloons (DCB). Subjects will be followed up clinically via office visit or phone visit at 6 and 12 months post procedure. This study is to demonstrate safety and assess the clinical use and outcomes of the Jetstream ™atherectomy device and Ranger™ DCB for the treatment of dysfunctional AV graft.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysfunctional Arterial-venous Grafts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Treatment of Jetstream™ atherectomy device and Ranger ™ drug coated balloons
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dysfunction AV graft
Arm Type
Experimental
Arm Description
Dysfunctional AV graft stenosis treated with atherectomy and drug coated balloon angioplasty
Intervention Type
Device
Intervention Name(s)
Atherectomy and balloon angioplasty
Intervention Description
Atherectomy and balloon angioplasty of arterial-venous graft stenosis
Primary Outcome Measure Information:
Title
Target Lesion Primary Patency (TLPP) through 6 months
Description
50% re-stenosis of the target lesion
Time Frame
within 6 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or non-pregnant, non-breastfeeding female ≥18 years of age; Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits; Target lesion must be a mature arteriovenous graft presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines; Subject has a target lesion at the venous anastomosis of the AVG; Successful crossing of the stenosis; Each lesion length is ≤20mm, which may include tandem lesions that are ≤20mm apart Exclusion Criteria: Subject is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this study; Subject has a non-controllable allergy to contrast; Subject has more than 3 lesions in the access circuit requiring intervention; Target lesion diameter >10mm; A thrombosed access or an access with a thrombosis treated ≤30 days prior to the index procedure; Prior surgical interventions of the access site ≤30 days before the index procedure; Target lesion is located within a bare metal or covered stent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kong Teng Tan, MD
Phone
416-340-4800
Ext
6166
Email
kongteng.tan@uhn.ca
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Atherectomy and Drug Coated Balloon for the Treatment of Arterio-Venous Graft Stenosis

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