Recruiting

Jetstream & Ranger

Sponsor:

University Health Network, Toronto

Code:

NCT04627051

Conditions

Dysfunctional Arterial-venous Grafts

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Atherectomy and balloon angioplasty

Study Details

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.

Conditions

Dysfunctional Arterial-venous Grafts

Study ID

NCT04627051

Start date

Nov 12, 2020

Status verified date

Nov, 2020

Completion date

Jan, 2023

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dysfunction AV graft

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

Interventions

Atherectomy and balloon angioplasty

Atherectomy and balloon angioplasty of arterial-venous graft stenosis

Primary outcome measure

  • Target Lesion Primary Patency (TLPP) through 6 months [ Time Frame: within 6 months post intervention ]

Central Contacts and Locations

Central contacts

Kong Teng Tan, MD

416-340-4800kongteng.tan@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2N2

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 12, 2021

Last verified

Nov, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2021-03-12.