Hemodialysis Access Failure
Conditions
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
Interventions
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Sponsors
SurModics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Target Lesion Primary Patency at 6 Months Post Procedure | 6 months | Freedom from clinically-driven target lesion revascularization (CD-TLR) or access thrombosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Absence of All Cause Death up to 30 Days (CEC Adjudicated) | 30 days | — |
| Number and Rate of Patients With Device and Procedure Related Adverse Events (CEC Adjudicated) | 30 days | — |
| Number of Participants With Secondary Functional Patency | Through 6 months | Secondary Patency is defined as supporting hemodialysis with a pump speed of at least 300ml/min through 6 months. |
| Number of Participants With Subsequent Reinterventions, Such as Angioplasty, Stent, Fistula, That Are Required to Maintain Target Lesion Patency (CEC-Adjudicated) | 30 days and 6 months | — |
| Number of Participants With Patency of Target Lesion as Defined by Duplex Ultrasound (Reported by DUS Core Lab) | 30 days | Patency is defined as \<50% restenosis within the target lesion. |
Countries
Australia, New Zealand
Participant flow
Recruitment details
Participants were recruited at two sites: site 100 - Prince of Wales Hospital, NSW Australia and site 101- Auckland City Hospital, Auckland, NZ. The first subject was enrolled at Site 100 on 5 Dec 2018, and at Site 101 on 12 Feb 2019. The last subject enrolled on 20 August 2019.
Pre-assignment details
A total of thirteen (13) subjects were consented with the EC-approved informed consent for the trial; twelve (12) were enrolled and treated within the study and one (1) subject was a screen failure.
Participants by arm
| Arm | Count |
|---|---|
| SurVeil Drug Coated Balloon Percutaneous transluminal angioplasty will be performed using the SurVeil™ Drug Coated Balloon (SurVeil DCB). | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Missed Visit | 1 |
Baseline characteristics
| Characteristic | SurVeil Drug Coated Balloon |
|---|---|
| Age, Continuous | 61.2 years STANDARD_DEVIATION 12.73 |
| BMI | 30.3 kg/m² STANDARD_DEVIATION 6.74 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 7 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 9 / 12 |
| serious Total, serious adverse events | 8 / 12 |
Outcome results
Primary
Number of Participants With Target Lesion Primary Patency at 6 Months Post Procedure
Freedom from clinically-driven target lesion revascularization (CD-TLR) or access thrombosis
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SurVeil Drug Coated Balloon | Number of Participants With Target Lesion Primary Patency at 6 Months Post Procedure | 11 Participants |
Secondary
Number and Rate of Patients With Device and Procedure Related Adverse Events (CEC Adjudicated)
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SurVeil Drug Coated Balloon | Number and Rate of Patients With Device and Procedure Related Adverse Events (CEC Adjudicated) | 1 Participants |
Secondary
Number of Participants With Absence of All Cause Death up to 30 Days (CEC Adjudicated)
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SurVeil Drug Coated Balloon | Number of Participants With Absence of All Cause Death up to 30 Days (CEC Adjudicated) | 12 Participants |
Secondary
Number of Participants With Patency of Target Lesion as Defined by Duplex Ultrasound (Reported by DUS Core Lab)
Patency is defined as \<50% restenosis within the target lesion.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SurVeil Drug Coated Balloon | Number of Participants With Patency of Target Lesion as Defined by Duplex Ultrasound (Reported by DUS Core Lab) | 11 Participants |
Secondary
Number of Participants With Patency of Target Lesion as Defined by Duplex Ultrasound (Reported by DUS Core Lab)
Patency is defined as \<50% restenosis within the target lesion.
Time frame: 6 months
Population: Two subjects were not included in the 6-month secondary endpoint analysis. One subject missed 6-month follow-up visit. One subject required an intervention to maintain patency during the 6-month timeframe.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SurVeil Drug Coated Balloon | Number of Participants With Patency of Target Lesion as Defined by Duplex Ultrasound (Reported by DUS Core Lab) | 2 Participants |
Secondary
Number of Participants With Secondary Functional Patency
Secondary Patency is defined as supporting hemodialysis with a pump speed of at least 300ml/min through 6 months.
Time frame: Through 6 months
Population: Three subjects did not have secondary functional assessed at six (6) months. One subject missed the 6-month visit. One subject underwent a kidney transplant prior to the six (6) month visit, therefore, this subject was not undergoing dialysis at this time. One subject was granted a protocol waiver by the Sponsor for trial enrollment. This subject had a mature fistula that had a treatable stenotic lesion for study entry; which has not been used for dialysis through the 6-month time period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SurVeil Drug Coated Balloon | Number of Participants With Secondary Functional Patency | 7 Participants |
Secondary
Number of Participants With Subsequent Reinterventions, Such as Angioplasty, Stent, Fistula, That Are Required to Maintain Target Lesion Patency (CEC-Adjudicated)
Time frame: 30 days and 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SurVeil Drug Coated Balloon | Number of Participants With Subsequent Reinterventions, Such as Angioplasty, Stent, Fistula, That Are Required to Maintain Target Lesion Patency (CEC-Adjudicated) | Through 30-Day visit | 0 Participants |
| SurVeil Drug Coated Balloon | Number of Participants With Subsequent Reinterventions, Such as Angioplasty, Stent, Fistula, That Are Required to Maintain Target Lesion Patency (CEC-Adjudicated) | Through 6-Month | 1 Participants |