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

  • STATUS
    Recruiting
  • End date
    Jan 19, 2023
  • participants needed
    30
  • sponsor
    University Health Network, Toronto
Updated on 19 March 2021

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.

Details
Condition Dysfunctional Arterial-venous Grafts, Dysfunctional Arterial-venous Grafts
Treatment Atherectomy and balloon angioplasty
Clinical Study IdentifierNCT04627051
SponsorUniversity Health Network, Toronto
Last Modified on19 March 2021

Eligibility

Yes No Not Sure

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
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