Clinical trial NCT03734679: Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (AVess FIH)
Official title: A Prospective, Multi-Center, Single-Arm Study to Assess the Safety and Performance of the Surmodics Drug Coated Balloon in the Treatment of Subjects With Obstructive Lesions of Arteriovenous Fistulae for Hemodialysis, Including Native or Synthetic Grafts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Access Failure
Lead sponsor: SurModics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Number of Participants With Target Lesion Primary Patency at 6 Months Post Procedure
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Absence of All Cause Death up to 30 Days (CEC Adjudicated)
timeFrame: 30 days
measure: Number and Rate of Patients With Device and Procedure Related Adverse Events (CEC Adjudicated)
timeFrame: 30 days
measure: Number of Participants With Secondary Functional Patency
timeFrame: Through 6 months
measure: Number of Participants With Subsequent Reinterventions, Such as Angioplasty, Stent, Fistula, That Are Required to Maintain Target Lesion Patency (CEC-Adjudicated)
timeFrame: 30 days and 6 months
measure: Number of Participants With Patency of Target Lesion as Defined by Duplex Ultrasound (Reported by DUS Core Lab)
timeFrame: 30 days
measure: Number of Participants With Patency of Target Lesion as Defined by Duplex Ultrasound (Reported by DUS Core Lab)
timeFrame: 6 months
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Prince of Wales Private Hospital
state: New South Wales
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
References: