Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (AVess FIH)

NCT ID: NCT03734679

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-05
• Study Completion Date: 2024-07-24

Brief Summary

The purpose of this study is to evaluate the safety and performance of the SurVeil DCB in subjects with obstructive lesions of arteriovenous fistulae for hemodialysis.

Detailed Description

AVess FIH is a prospective, multi-center, single arm, first-in-man feasibility study evaluating up to 15 subjects

Conditions

Hemodialysis Access Failure

Study Design

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

Study Groups

Surveil drug coated balloon

Group Type: EXPERIMENTAL

SurVeil Drug Coated Balloon

Intervention Type: DEVICE

Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.

Interventions

SurVeil Drug Coated Balloon

Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subjects must be ≥18 years of age.

2. Native AV fistula has been created ≥60 days prior to the index procedure.

3. AV fistula, located in the arm, has undergone one or more successful hemodialysis sessions.

4. Target de novo or non-stented restenotic lesion consisting of a ≥50% stenosis by operator visual estimate.

5. Fistula vessel diameter ≥5 mm and ≤7 mm by operator visual estimate.

6. Target lesion or tandem lesion ≤120 mm in total length by operator visual estimate.

7. Successful pre-dilatation of the target lesion. Defined as crossing of the guide wire AND pre-dilatation with a PTA balloon resulting in: residual stenosis of ≤30% and dissection ≤ Grade B

8. Subject has provided written informed consent and is willing to comply with study follow-up requirements.

9. Subject has a life expectancy of ≥1 year

Exclusion Criteria

1. Subject has a synthetic AV graft.

2. Determined by operator to have a lesion that prevents complete inflation of an angioplasty balloon.

3. Presence of pseudoaneurysm or aneurysm requiring treatment at the lesion site.

4. Target lesion is located <30 mm from any stent.

5. Thrombosis of the access site 30 days prior to procedure.

6. Surgical revision of the access site planned within 30 days of procedure.

7. Blood coagulative disorder, sepsis, or current AV access infection (white blood count ≥12,000).

8. Known contraindication (including allergic reaction) or sensitivity to antiplatelet therapy, anticoagulation therapy or paclitaxel (mild to severe cases), that cannot be adequately managed with pre-and post-procedure medication.

9. Subjects who are taking immunosuppressive therapy or are routinely taking ≥10mg of prednisone per day.

10. Scheduled for kidney transplant or peritoneal dialysis within the next 6 months post procedure.

11. Myocardial infarction 30 days prior to procedure.

12. Stroke or TIA 90 days prior to procedure.

13. Women who are pregnant, breast-feeding or intend to become pregnant or men who intend to father children during the time of the study.

14. Subject is participating in any other investigational study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoint from this study.

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

Sponsors

SurModics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Prince of Wales Private Hospital

Randwick, New South Wales, Australia

Auckland City Hospital

Auckland, , New Zealand

Countries

Australia; New Zealand

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SUR18-001

Identifier Type: -

Identifier Source: org_study_id