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

NCT ID: NCT04627051

Last Updated: 2021-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-12
• Study Completion Date: 2023-01-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dysfunction AV graft

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

Group Type: EXPERIMENTAL

Atherectomy and balloon angioplasty

Intervention Type: DEVICE

Atherectomy and balloon angioplasty of arterial-venous graft stenosis

Interventions

Atherectomy and balloon angioplasty

Atherectomy and balloon angioplasty of arterial-venous graft stenosis

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Health Network

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Kong Teng Tan, MD

Role: CONTACT

kongteng.tan@uhn.ca

416-340-4800 ext. 6166

Other Identifiers

20-5673

Identifier Type: -

Identifier Source: org_study_id