Arteriovenous Fistula, Arteriovenous Fistula Occlusion, Arteriovenous Fistula Stenosis, Fistula
Conditions
Brief summary
To evaluate the safety and efficacy of the IN.PACT™ AV Access Drug Coated Balloon (DCB) compared to percutaneous transluminal angioplasty (PTA) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity.
Detailed description
This is a prospective, global, multi-center, single-blinded, 1:1 randomized clinical trial evaluating the IN.PACT™ AV Access Drug Coated Balloon (DCB) compared to percutaneous transluminal angioplasty (PTA) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity. The trial will be conducted in up to 30 sites in the United States, Japan, and New Zealand.
Interventions
DEVICEIN.PACT AV DCB
IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
Standard PTA Balloon
Sponsors
Medtronic Endovascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is ≥21 years of age. 2. Patient has a life expectancy of ≥ 12 months 3. Patient has a native AV fistula created ≥ 60 days prior to the index procedure 4. The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions during a four week period 5. Patient has a de novo and/or non-stented restenotic lesion located between the arteriovenous anastomosis and axillosubclavian junction with ≥50% stenosis. Note: If the lesion is located in the anastomosis, the treatment may be delivered up to 2 cm upstream on the arterial side. If the lesion is located in the cephalic arch, the treatment may be delivered up to 2 cm into the subclavian vein 6. Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length (by visual estimate) Note: Tandem lesions may be enrolled provided they meet all of the following criteria: Separated by a gap of ≤ 30mm (3 cm), total combined lesion length, including 30 mm gap, ≤ 100 mm, and able to be treated as a single lesion 7. Patient has a target vessel diameter of 4.0 - 12.0 mm (by visual estimate). 8. Patient underwent successful crossing of the target lesion with the guide wire and pre-dilatation with a high pressure PTA balloon defined as: residual stenosis of ≤ 30% and absence of a flow limiting dissection (Grade ≥ C) or perforation 9. Patient provides written consent prior to enrollment in the study 10. Patient is willing to comply with all follow-up evaluations at specified times
Exclusion criteria
1. Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children 2. Patient is receiving immunosuppressive therapy 3. Patient is anticipating a kidney transplant within 6 months of enrollment into the study 4. Patient has undergone prior intervention of access site within 30 days of index procedure 5. Patient with anticipated conversion to peritoneal dialysis 6. Patient has an infected AV access or systemic infection 7. Patient has planned surgical revision of access site 8. Patient with secondary non-target lesion requiring treatment within 30-days post index procedure 9. Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion 10. Patient with target AVF or access circuit which previously had or currently has a thrombosis 11. Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system 12. Patient with target lesion located central to the axillosubclavian junction 13. Patient has significant arterial inflow lesion requiring treatment more than 2 cm upstream from the anastomosis in the AV access 14. Patient has presence of pseudoaneurysm or aneurysm requiring treatment at the lesion site 15. Patient has presence of a stent located in the target AV access circuit 16. Patients with known allergies or sensitivities to paclitaxel 17. Patient with known contraindication, including allergic reaction, or sensitivity to contrast material that cannot be adequately pre-treated 18. Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy 19. Patient with clinically significant Steal Syndrome requiring treatment 20. Patient is enrolled in another investigational drug, device, or biological study and has not completed the primary endpoint, or was previously enrolled in this study 21. Patient has a comorbid-condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol of confound data interpretation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint - Serious Adverse Event Rate | 30 days post procedure | Serious Adverse Event (SAE) rate involving the AV access circuit |
| Target Lesion Primary Patency Rate Through 6 Months | 6 Months Post-Procedure | Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure. | Resumption of successful dialysis for at least one session after index procedure. |
| Cumulative Target Lesion Revascularizations | 3, 6, 9,12, 18, and 24 Months | The number and percentage of participants with target lesion revascularizations through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure. |
| Total Number of Interventions Required to Maintain Target Lesion Patency | 3, 6, 9, 12, 18, and 24 Months | The number of target lesion revascularizations per treatment arm through 3 months, 6 months, 9 months, 12 months,18 months, and 24 months post-procedure. |
| Total Number of Interventions Required to Maintain Access Circuit Patency | 3, 6, 9, 12, 18, and 24 Months | The number of re-interventions in the target lesion and/or access circuit through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months. |
| Cumulative Access Circuit Thromboses | 3, 6, 9, 12, 18, and 24 Months | The number and percentage of participants with access circuit thrombosis through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. |
| Device Success | Time of Procedure | Device Success is defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device without burst at or below rated burst pressure (RBP) during the index procedure. |
| Procedure Success | Time of Procedure | Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE). |
| Access Circuit Primary Patency | 3, 6, 9, 12, 18, and 24 Months | Defined as freedom from re-intervention in the access circuit or access circuit thrombosis through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure. |
| Procedure Related Adverse Event Rate | 30 Days, 3, 6, 9, 12, 18, and 24 Months | Procedure Related Adverse Event Rate: defined as the number and percentage of participants with procedure related Adverse Events reported post-index procedure until the first successful dialysis session through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. |
| Target Lesion Revascularizations (TLR) | 6, 9, 12, 18, 24, and 36 Months | Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure. |
| Clinically-Driven Target Lesion Revascularizations (CD-TLR) | 6, 9, 12, 18, 24, and 36 Months | Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence with CD-TLR up to 36 months post index procedure |
| Re-interventions in the Access Circuit | 6, 9, 12, 18, 24, and 36 Months | Defined as the percentage of participants who had a reinterventions occurring within the access circuit. The Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure. |
| Abandonment of Target AVF | 6, 9, 12, 18, 24, and 36 Months | Defined as number of participants with abandonment of the target AV up to 36 months post-index procedure. |
| Serious Adverse Event Rate | 6, 12, 24, and 36 Months | Serious Adverse Event Rate: defined as the number and percentage of participants with one or more Serious Adverse Events reported post-index procedure through 6 months, 12 months, 24 months, and 36 months. |
| Rate of Freedom From All-Cause Mortality Post Vital Status Update | 6, 12, 24, 36, 48, and 60 Months | Percentage of participants who had all-cause death post vital status update. The Kaplan-Meier method was used to estimate survival probability up to 60 months post-index procedure through 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. |
| Rate of Device Related Adverse Events | 30 days, 3, 6, 9, 12, 18, and 24 Months. | Device Related Adverse Event Rate: defined as the number and percentage of participants with device related Adverse Events through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. |
| Target Lesion Primary Patency | 3, 9, 12, 18, and 24 Months | Percentage of participants with freedom from clinically driven target lesion revascularization or access thrombosis occurring in the target lesion through 3 months, 9 months,12 months, 18 months, and 24 months post-procedure. |
Countries
Japan, New Zealand, United States
Participant flow
Recruitment details
330 subjects from 21 US sites and 8 OUS sites contributed to the global cohort. 204 of subjects came from U.S. sites, 112 of subjects came from Japan sites, and 14 of subjects came from New Zealand sites. There was no minimum enrollment requirement at each site; individual sites were not allowed to enroll more than 20% of the total study subjects.
Pre-assignment details
A total of 488 patients were consented to be reviewed for enrollment. 158 patients were not enrolled in the study. 170 subjects were randomized to IN.PACT AV Drug Coated Balloon treatment and 160 subjects were randomized to the Standard PTA Treatment.
Participants by arm
| Arm | Count |
|---|---|
| IN.PACT AV DCB PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon | 170 |
| Standard Balloon Angioplasty PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon | 160 |
| Total | 330 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 46 | 39 |
| Overall Study | Declined consent for study extension | 21 | 33 |
| Overall Study | Exit reason other than withdrawal, death, or lost to follow up | 4 | 2 |
| Overall Study | Lost to Follow-up | 6 | 8 |
| Overall Study | Withdrawal by Subject | 36 | 37 |
Baseline characteristics
| Characteristic | IN.PACT AV DCB | Standard Balloon Angioplasty | Total |
|---|---|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 13.1 | 65.5 years STANDARD_DEVIATION 13.4 | 65.6 years STANDARD_DEVIATION 13.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 14 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 152 Participants | 143 Participants | 295 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 63 Participants | 57 Participants | 120 Participants |
| Race/Ethnicity, Customized Black or African American | 54 Participants | 48 Participants | 102 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 6 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized White | 42 Participants | 46 Participants | 88 Participants |
| Region of Enrollment Japan | 58 participants | 54 participants | 112 participants |
| Region of Enrollment New Zealand | 8 participants | 6 participants | 14 participants |
| Region of Enrollment United States | 104 participants | 100 participants | 204 participants |
| Sex: Female, Male Female | 58 Participants | 59 Participants | 117 Participants |
| Sex: Female, Male Male | 112 Participants | 101 Participants | 213 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 59 / 170 | 60 / 160 |
| other Total, other adverse events | 31 / 170 | 32 / 160 |
| serious Total, serious adverse events | 148 / 170 | 143 / 160 |
Outcome results
Primary
Primary Safety Endpoint - Serious Adverse Event Rate
Serious Adverse Event (SAE) rate involving the AV access circuit
Time frame: 30 days post procedure
Population: All subjects with events or subjects without events but had at least 23 days of clinical follow-up were counted as evaluable subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IN.PACT AV DCB | Primary Safety Endpoint - Serious Adverse Event Rate | 7 Participants |
| Standard Balloon Angioplasty | Primary Safety Endpoint - Serious Adverse Event Rate | 7 Participants |
p-value: 0.002Farrington-Manning Test
Primary
Target Lesion Primary Patency Rate Through 6 Months
Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.
Time frame: 6 Months Post-Procedure
Population: Evaluable subjects were all subjects with events or subjects without events but had at least 150 days of clinical follow-up were counted as evaluable subjects. If a subject had no event and abandoned AV Access circuit within 150 days the subject will be considered not evaluable for 6-months effectiveness endpoints.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IN.PACT AV DCB | Target Lesion Primary Patency Rate Through 6 Months | 125 Participants |
| Standard Balloon Angioplasty | Target Lesion Primary Patency Rate Through 6 Months | 88 Participants |
p-value: <0.001One-sided Z-test
Secondary
Abandonment of Target AVF
Defined as number of participants with abandonment of the target AV up to 36 months post-index procedure.
Time frame: 6, 9, 12, 18, 24, and 36 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IN.PACT AV DCB | Abandonment of Target AVF | 18 Months | 13 Participants |
| IN.PACT AV DCB | Abandonment of Target AVF | 9 Months | 3 Participants |
| IN.PACT AV DCB | Abandonment of Target AVF | 24 Months | 18 Participants |
| IN.PACT AV DCB | Abandonment of Target AVF | 12 Months | 5 Participants |
| IN.PACT AV DCB | Abandonment of Target AVF | 36 Months | 23 Participants |
| IN.PACT AV DCB | Abandonment of Target AVF | 6 Months | 2 Participants |
| Standard Balloon Angioplasty | Abandonment of Target AVF | 36 Months | 25 Participants |
| Standard Balloon Angioplasty | Abandonment of Target AVF | 6 Months | 9 Participants |
| Standard Balloon Angioplasty | Abandonment of Target AVF | 12 Months | 14 Participants |
| Standard Balloon Angioplasty | Abandonment of Target AVF | 18 Months | 18 Participants |
| Standard Balloon Angioplasty | Abandonment of Target AVF | 24 Months | 22 Participants |
| Standard Balloon Angioplasty | Abandonment of Target AVF | 9 Months | 10 Participants |
Secondary
Access Circuit Primary Patency
Defined as freedom from re-intervention in the access circuit or access circuit thrombosis through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.
Time frame: 3, 6, 9, 12, 18, and 24 Months
Population: There is no planned hypothesis test other than at 6 months time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IN.PACT AV DCB | Access Circuit Primary Patency | 3 Months | 91.4 Percentage of participants |
| IN.PACT AV DCB | Access Circuit Primary Patency | 6 Months | 72.5 Percentage of participants |
| IN.PACT AV DCB | Access Circuit Primary Patency | 9 Months | 66.8 Percentage of participants |
| IN.PACT AV DCB | Access Circuit Primary Patency | 12 Months | 55.1 Percentage of participants |
| IN.PACT AV DCB | Access Circuit Primary Patency | 18 Months | 43.6 Percentage of participants |
| IN.PACT AV DCB | Access Circuit Primary Patency | 24 Months | 39.5 Percentage of participants |
| Standard Balloon Angioplasty | Access Circuit Primary Patency | 18 Months | 28.8 Percentage of participants |
| Standard Balloon Angioplasty | Access Circuit Primary Patency | 3 Months | 84.6 Percentage of participants |
| Standard Balloon Angioplasty | Access Circuit Primary Patency | 12 Months | 35.0 Percentage of participants |
| Standard Balloon Angioplasty | Access Circuit Primary Patency | 6 Months | 48.0 Percentage of participants |
| Standard Balloon Angioplasty | Access Circuit Primary Patency | 24 Months | 25.4 Percentage of participants |
| Standard Balloon Angioplasty | Access Circuit Primary Patency | 9 Months | 43.1 Percentage of participants |
Comparison: Kaplan-Meier method was used to estimate access circuit primary patency.p-value: <0.001Log Rank
Secondary
Clinically-Driven Target Lesion Revascularizations (CD-TLR)
Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence with CD-TLR up to 36 months post index procedure
Time frame: 6, 9, 12, 18, 24, and 36 Months
Population: There is no planned hypothesis test for this endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IN.PACT AV DCB | Clinically-Driven Target Lesion Revascularizations (CD-TLR) | 6 Months | 12.3 Percentage of participants |
| IN.PACT AV DCB | Clinically-Driven Target Lesion Revascularizations (CD-TLR) | 9 Months | 23.4 Percentage of participants |
| IN.PACT AV DCB | Clinically-Driven Target Lesion Revascularizations (CD-TLR) | 12 Months | 33.7 Percentage of participants |
| IN.PACT AV DCB | Clinically-Driven Target Lesion Revascularizations (CD-TLR) | 18 Months | 42.7 Percentage of participants |
| IN.PACT AV DCB | Clinically-Driven Target Lesion Revascularizations (CD-TLR) | 24 Months | 47.0 Percentage of participants |
| IN.PACT AV DCB | Clinically-Driven Target Lesion Revascularizations (CD-TLR) | 36 Months | 54.9 Percentage of participants |
| Standard Balloon Angioplasty | Clinically-Driven Target Lesion Revascularizations (CD-TLR) | 24 Months | 62.0 Percentage of participants |
| Standard Balloon Angioplasty | Clinically-Driven Target Lesion Revascularizations (CD-TLR) | 6 Months | 30.4 Percentage of participants |
| Standard Balloon Angioplasty | Clinically-Driven Target Lesion Revascularizations (CD-TLR) | 18 Months | 60.1 Percentage of participants |
| Standard Balloon Angioplasty | Clinically-Driven Target Lesion Revascularizations (CD-TLR) | 9 Months | 44.8 Percentage of participants |
| Standard Balloon Angioplasty | Clinically-Driven Target Lesion Revascularizations (CD-TLR) | 36 Months | 69.1 Percentage of participants |
| Standard Balloon Angioplasty | Clinically-Driven Target Lesion Revascularizations (CD-TLR) | 12 Months | 51.8 Percentage of participants |
Secondary
Clinical Success
Resumption of successful dialysis for at least one session after index procedure.
Time frame: From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IN.PACT AV DCB | Clinical Success | 159 Participants |
| Standard Balloon Angioplasty | Clinical Success | 154 Participants |
p-value: >0.999Chi-squared
Secondary
Cumulative Access Circuit Thromboses
The number and percentage of participants with access circuit thrombosis through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Time frame: 3, 6, 9, 12, 18, and 24 Months
Population: Participant withdrawn or lost-to-follow-up are included in the analyses up to the time consent was withdrawn, or they were exited, whichever is earlier.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IN.PACT AV DCB | Cumulative Access Circuit Thromboses | Access Circuit Thromboses Within 3 Months | 2 Participants |
| IN.PACT AV DCB | Cumulative Access Circuit Thromboses | Access Circuit Thromboses Within 6 Months | 3 Participants |
| IN.PACT AV DCB | Cumulative Access Circuit Thromboses | Access Circuit Thromboses Within 9 Months | 3 Participants |
| IN.PACT AV DCB | Cumulative Access Circuit Thromboses | Access Circuit Thromboses Within 12 Months | 4 Participants |
| IN.PACT AV DCB | Cumulative Access Circuit Thromboses | Access Circuit Thromboses Within 18 Months | 7 Participants |
| IN.PACT AV DCB | Cumulative Access Circuit Thromboses | Access Circuit Thromboses Within 24 Months | 7 Participants |
| Standard Balloon Angioplasty | Cumulative Access Circuit Thromboses | Access Circuit Thromboses Within 18 Months | 11 Participants |
| Standard Balloon Angioplasty | Cumulative Access Circuit Thromboses | Access Circuit Thromboses Within 3 Months | 1 Participants |
| Standard Balloon Angioplasty | Cumulative Access Circuit Thromboses | Access Circuit Thromboses Within 12 Months | 8 Participants |
| Standard Balloon Angioplasty | Cumulative Access Circuit Thromboses | Access Circuit Thromboses Within 6 Months | 5 Participants |
| Standard Balloon Angioplasty | Cumulative Access Circuit Thromboses | Access Circuit Thromboses Within 24 Months | 13 Participants |
| Standard Balloon Angioplasty | Cumulative Access Circuit Thromboses | Access Circuit Thromboses Within 9 Months | 7 Participants |
Secondary
Cumulative Target Lesion Revascularizations
The number and percentage of participants with target lesion revascularizations through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.
Time frame: 3, 6, 9,12, 18, and 24 Months
Population: Participants are included in the analyses up to the time consent was withdrawn, or they were exited, whichever is earlier.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IN.PACT AV DCB | Cumulative Target Lesion Revascularizations | 3 Months | 8 Participants |
| IN.PACT AV DCB | Cumulative Target Lesion Revascularizations | 6 Months | 25 Participants |
| IN.PACT AV DCB | Cumulative Target Lesion Revascularizations | 9 Months | 42 Participants |
| IN.PACT AV DCB | Cumulative Target Lesion Revascularizations | 12 Months | 57 Participants |
| IN.PACT AV DCB | Cumulative Target Lesion Revascularizations | 18 Months | 70 Participants |
| IN.PACT AV DCB | Cumulative Target Lesion Revascularizations | 24 Months | 76 Participants |
| Standard Balloon Angioplasty | Cumulative Target Lesion Revascularizations | 18 Months | 97 Participants |
| Standard Balloon Angioplasty | Cumulative Target Lesion Revascularizations | 3 Months | 19 Participants |
| Standard Balloon Angioplasty | Cumulative Target Lesion Revascularizations | 12 Months | 88 Participants |
| Standard Balloon Angioplasty | Cumulative Target Lesion Revascularizations | 6 Months | 59 Participants |
| Standard Balloon Angioplasty | Cumulative Target Lesion Revascularizations | 24 Months | 101 Participants |
| Standard Balloon Angioplasty | Cumulative Target Lesion Revascularizations | 9 Months | 78 Participants |
p-value: <0.001Chi-squared
Secondary
Device Success
Device Success is defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device without burst at or below rated burst pressure (RBP) during the index procedure.
Time frame: Time of Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IN.PACT AV DCB | Device Success | 212 Devices successfully used |
| Standard Balloon Angioplasty | Device Success | 161 Devices successfully used |
p-value: >0.999Chi-squared
Secondary
Procedure Related Adverse Event Rate
Procedure Related Adverse Event Rate: defined as the number and percentage of participants with procedure related Adverse Events reported post-index procedure until the first successful dialysis session through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Time frame: 30 Days, 3, 6, 9, 12, 18, and 24 Months
Population: Number of Participants with One or More Procedure-Related Adverse Events
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IN.PACT AV DCB | Procedure Related Adverse Event Rate | Subjects with Procedure-Related AEs within 6 Months | 7 Participants |
| IN.PACT AV DCB | Procedure Related Adverse Event Rate | Subjects with Procedure-Related AEs within 12 Months | 8 Participants |
| IN.PACT AV DCB | Procedure Related Adverse Event Rate | Subjects with Procedure-Related AEs within 3 Months | 7 Participants |
| IN.PACT AV DCB | Procedure Related Adverse Event Rate | Subjects with Procedure-Related AEs within 18 Months | 8 Participants |
| IN.PACT AV DCB | Procedure Related Adverse Event Rate | Subjects with Procedure-Related AEs within 9 Months | 8 Participants |
| IN.PACT AV DCB | Procedure Related Adverse Event Rate | Subjects with Procedure-Related AEs within 24 Months | 8 Participants |
| IN.PACT AV DCB | Procedure Related Adverse Event Rate | Subjects with Procedure-Related AEs within 30 Days | 7 Participants |
| Standard Balloon Angioplasty | Procedure Related Adverse Event Rate | Subjects with Procedure-Related AEs within 24 Months | 8 Participants |
| Standard Balloon Angioplasty | Procedure Related Adverse Event Rate | Subjects with Procedure-Related AEs within 30 Days | 7 Participants |
| Standard Balloon Angioplasty | Procedure Related Adverse Event Rate | Subjects with Procedure-Related AEs within 3 Months | 7 Participants |
| Standard Balloon Angioplasty | Procedure Related Adverse Event Rate | Subjects with Procedure-Related AEs within 6 Months | 7 Participants |
| Standard Balloon Angioplasty | Procedure Related Adverse Event Rate | Subjects with Procedure-Related AEs within 9 Months | 8 Participants |
| Standard Balloon Angioplasty | Procedure Related Adverse Event Rate | Subjects with Procedure-Related AEs within 12 Months | 8 Participants |
| Standard Balloon Angioplasty | Procedure Related Adverse Event Rate | Subjects with Procedure-Related AEs within 18 Months | 8 Participants |
Secondary
Procedure Success
Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).
Time frame: Time of Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IN.PACT AV DCB | Procedure Success | 125 Participants |
| Standard Balloon Angioplasty | Procedure Success | 122 Participants |
p-value: 0.482Chi-squared
Secondary
Rate of Device Related Adverse Events
Device Related Adverse Event Rate: defined as the number and percentage of participants with device related Adverse Events through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Time frame: 30 days, 3, 6, 9, 12, 18, and 24 Months.
Population: Number of Participants with One or More Device-Related Adverse Events
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IN.PACT AV DCB | Rate of Device Related Adverse Events | Subjects with device related AEs within 6 Months | 10 Participants |
| IN.PACT AV DCB | Rate of Device Related Adverse Events | Subjects with device related AEs within 12 Months | 12 Participants |
| IN.PACT AV DCB | Rate of Device Related Adverse Events | Subjects with device related AEs within 3 Months | 7 Participants |
| IN.PACT AV DCB | Rate of Device Related Adverse Events | Subjects with device related AEs within 18 Months | 11 Participants |
| IN.PACT AV DCB | Rate of Device Related Adverse Events | Subjects with device related AEs within 9 Months | 12 Participants |
| IN.PACT AV DCB | Rate of Device Related Adverse Events | Subjects with device related AEs within 24 Months | 11 Participants |
| IN.PACT AV DCB | Rate of Device Related Adverse Events | Subjects with device related AEs within 30 days | 2 Participants |
| Standard Balloon Angioplasty | Rate of Device Related Adverse Events | Subjects with device related AEs within 24 Months | 9 Participants |
| Standard Balloon Angioplasty | Rate of Device Related Adverse Events | Subjects with device related AEs within 30 days | 2 Participants |
| Standard Balloon Angioplasty | Rate of Device Related Adverse Events | Subjects with device related AEs within 3 Months | 5 Participants |
| Standard Balloon Angioplasty | Rate of Device Related Adverse Events | Subjects with device related AEs within 6 Months | 7 Participants |
| Standard Balloon Angioplasty | Rate of Device Related Adverse Events | Subjects with device related AEs within 9 Months | 9 Participants |
| Standard Balloon Angioplasty | Rate of Device Related Adverse Events | Subjects with device related AEs within 12 Months | 9 Participants |
| Standard Balloon Angioplasty | Rate of Device Related Adverse Events | Subjects with device related AEs within 18 Months | 9 Participants |
Secondary
Rate of Freedom From All-Cause Mortality Post Vital Status Update
Percentage of participants who had all-cause death post vital status update. The Kaplan-Meier method was used to estimate survival probability up to 60 months post-index procedure through 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months.
Time frame: 6, 12, 24, 36, 48, and 60 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IN.PACT AV DCB | Rate of Freedom From All-Cause Mortality Post Vital Status Update | Within 180 Days | 93.4 % of Survival |
| IN.PACT AV DCB | Rate of Freedom From All-Cause Mortality Post Vital Status Update | Within 360 Days | 89.1 % of Survival |
| IN.PACT AV DCB | Rate of Freedom From All-Cause Mortality Post Vital Status Update | Within 720 Days | 80.2 % of Survival |
| IN.PACT AV DCB | Rate of Freedom From All-Cause Mortality Post Vital Status Update | Within 1080 Days | 73.4 % of Survival |
| IN.PACT AV DCB | Rate of Freedom From All-Cause Mortality Post Vital Status Update | Within 1440 Days | 65.4 % of Survival |
| IN.PACT AV DCB | Rate of Freedom From All-Cause Mortality Post Vital Status Update | Within 1800Days | 59.0 % of Survival |
| Standard Balloon Angioplasty | Rate of Freedom From All-Cause Mortality Post Vital Status Update | Within 1440 Days | 58.2 % of Survival |
| Standard Balloon Angioplasty | Rate of Freedom From All-Cause Mortality Post Vital Status Update | Within 180 Days | 98.1 % of Survival |
| Standard Balloon Angioplasty | Rate of Freedom From All-Cause Mortality Post Vital Status Update | Within 1080 Days | 68.8 % of Survival |
| Standard Balloon Angioplasty | Rate of Freedom From All-Cause Mortality Post Vital Status Update | Within 360 Days | 89.6 % of Survival |
| Standard Balloon Angioplasty | Rate of Freedom From All-Cause Mortality Post Vital Status Update | Within 1800Days | 53.5 % of Survival |
| Standard Balloon Angioplasty | Rate of Freedom From All-Cause Mortality Post Vital Status Update | Within 720 Days | 81.8 % of Survival |
Secondary
Re-interventions in the Access Circuit
Defined as the percentage of participants who had a reinterventions occurring within the access circuit. The Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.
Time frame: 6, 9, 12, 18, 24, and 36 Months
Population: There is no planned hypothesis test for this endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IN.PACT AV DCB | Re-interventions in the Access Circuit | 6 Months | 20.4 Percentage of participants |
| IN.PACT AV DCB | Re-interventions in the Access Circuit | 9 Months | 32.2 Percentage of participants |
| IN.PACT AV DCB | Re-interventions in the Access Circuit | 12 Months | 43.7 Percentage of participants |
| IN.PACT AV DCB | Re-interventions in the Access Circuit | 18 Months | 55.6 Percentage of participants |
| IN.PACT AV DCB | Re-interventions in the Access Circuit | 24 Months | 59.8 Percentage of participants |
| IN.PACT AV DCB | Re-interventions in the Access Circuit | 36 Months | 71.9 Percentage of participants |
| Standard Balloon Angioplasty | Re-interventions in the Access Circuit | 24 Months | 74.2 Percentage of participants |
| Standard Balloon Angioplasty | Re-interventions in the Access Circuit | 6 Months | 44.0 Percentage of participants |
| Standard Balloon Angioplasty | Re-interventions in the Access Circuit | 18 Months | 70.8 Percentage of participants |
| Standard Balloon Angioplasty | Re-interventions in the Access Circuit | 9 Months | 56.8 Percentage of participants |
| Standard Balloon Angioplasty | Re-interventions in the Access Circuit | 36 Months | 83.1 Percentage of participants |
| Standard Balloon Angioplasty | Re-interventions in the Access Circuit | 12 Months | 65.1 Percentage of participants |
Secondary
Serious Adverse Event Rate
Serious Adverse Event Rate: defined as the number and percentage of participants with one or more Serious Adverse Events reported post-index procedure through 6 months, 12 months, 24 months, and 36 months.
Time frame: 6, 12, 24, and 36 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IN.PACT AV DCB | Serious Adverse Event Rate | Subjects with SAEs within 180 Days | 71 Participants |
| IN.PACT AV DCB | Serious Adverse Event Rate | Subjects with SAEs within 360 Days | 105 Participants |
| IN.PACT AV DCB | Serious Adverse Event Rate | Subjects with SAEs within 720 Days | 131 Participants |
| IN.PACT AV DCB | Serious Adverse Event Rate | Subjects with SAEs within 1080 Days | 146 Participants |
| Standard Balloon Angioplasty | Serious Adverse Event Rate | Subjects with SAEs within 1080 Days | 137 Participants |
| Standard Balloon Angioplasty | Serious Adverse Event Rate | Subjects with SAEs within 180 Days | 85 Participants |
| Standard Balloon Angioplasty | Serious Adverse Event Rate | Subjects with SAEs within 720 Days | 128 Participants |
| Standard Balloon Angioplasty | Serious Adverse Event Rate | Subjects with SAEs within 360 Days | 115 Participants |
Secondary
Target Lesion Primary Patency
Percentage of participants with freedom from clinically driven target lesion revascularization or access thrombosis occurring in the target lesion through 3 months, 9 months,12 months, 18 months, and 24 months post-procedure.
Time frame: 3, 9, 12, 18, and 24 Months
Population: There is no planned hypothesis test other than at 6 months time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IN.PACT AV DCB | Target Lesion Primary Patency | 3 Months | 96.9 percentage of participants |
| IN.PACT AV DCB | Target Lesion Primary Patency | 18 Months | 56.4 percentage of participants |
| IN.PACT AV DCB | Target Lesion Primary Patency | 9 Months | 75.6 percentage of participants |
| IN.PACT AV DCB | Target Lesion Primary Patency | 24 Months | 52.2 percentage of participants |
| IN.PACT AV DCB | Target Lesion Primary Patency | 12 Months | 65.3 percentage of participants |
| Standard Balloon Angioplasty | Target Lesion Primary Patency | 24 Months | 36.2 percentage of participants |
| Standard Balloon Angioplasty | Target Lesion Primary Patency | 12 Months | 46.3 percentage of participants |
| Standard Balloon Angioplasty | Target Lesion Primary Patency | 3 Months | 90.3 percentage of participants |
| Standard Balloon Angioplasty | Target Lesion Primary Patency | 9 Months | 54.5 percentage of participants |
| Standard Balloon Angioplasty | Target Lesion Primary Patency | 18 Months | 38.0 percentage of participants |
Comparison: Kaplan-Meier method was used to estimate target lesion primary patency.p-value: <0.001Log Rank
Secondary
Target Lesion Revascularizations (TLR)
Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.
Time frame: 6, 9, 12, 18, 24, and 36 Months
Population: There is no planned hypothesis test.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IN.PACT AV DCB | Target Lesion Revascularizations (TLR) | 6 Months | 16.0 % of Cumulative Incidence Rate |
| IN.PACT AV DCB | Target Lesion Revascularizations (TLR) | 9 Months | 27.8 % of Cumulative Incidence Rate |
| IN.PACT AV DCB | Target Lesion Revascularizations (TLR) | 12 Months | 38.7 % of Cumulative Incidence Rate |
| IN.PACT AV DCB | Target Lesion Revascularizations (TLR) | 18 Months | 48.4 % of Cumulative Incidence Rate |
| IN.PACT AV DCB | Target Lesion Revascularizations (TLR) | 24 Months | 53.6 % of Cumulative Incidence Rate |
| IN.PACT AV DCB | Target Lesion Revascularizations (TLR) | 36 Months | 62.5 % of Cumulative Incidence Rate |
| Standard Balloon Angioplasty | Target Lesion Revascularizations (TLR) | 24 Months | 69.9 % of Cumulative Incidence Rate |
| Standard Balloon Angioplasty | Target Lesion Revascularizations (TLR) | 6 Months | 39.6 % of Cumulative Incidence Rate |
| Standard Balloon Angioplasty | Target Lesion Revascularizations (TLR) | 18 Months | 66.3 % of Cumulative Incidence Rate |
| Standard Balloon Angioplasty | Target Lesion Revascularizations (TLR) | 9 Months | 53.1 % of Cumulative Incidence Rate |
| Standard Balloon Angioplasty | Target Lesion Revascularizations (TLR) | 36 Months | 79.3 % of Cumulative Incidence Rate |
| Standard Balloon Angioplasty | Target Lesion Revascularizations (TLR) | 12 Months | 59.9 % of Cumulative Incidence Rate |
Secondary
Total Number of Interventions Required to Maintain Access Circuit Patency
The number of re-interventions in the target lesion and/or access circuit through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months.
Time frame: 3, 6, 9, 12, 18, and 24 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IN.PACT AV DCB | Total Number of Interventions Required to Maintain Access Circuit Patency | 3 Months | 16 Total number of interventons |
| IN.PACT AV DCB | Total Number of Interventions Required to Maintain Access Circuit Patency | 6 Months | 44 Total number of interventons |
| IN.PACT AV DCB | Total Number of Interventions Required to Maintain Access Circuit Patency | 9 Months | 74 Total number of interventons |
| IN.PACT AV DCB | Total Number of Interventions Required to Maintain Access Circuit Patency | 12 Months | 110 Total number of interventons |
| IN.PACT AV DCB | Total Number of Interventions Required to Maintain Access Circuit Patency | 18 Months | 180 Total number of interventons |
| IN.PACT AV DCB | Total Number of Interventions Required to Maintain Access Circuit Patency | 24 Months | 232 Total number of interventons |
| Standard Balloon Angioplasty | Total Number of Interventions Required to Maintain Access Circuit Patency | 18 Months | 248 Total number of interventons |
| Standard Balloon Angioplasty | Total Number of Interventions Required to Maintain Access Circuit Patency | 3 Months | 23 Total number of interventons |
| Standard Balloon Angioplasty | Total Number of Interventions Required to Maintain Access Circuit Patency | 12 Months | 168 Total number of interventons |
| Standard Balloon Angioplasty | Total Number of Interventions Required to Maintain Access Circuit Patency | 6 Months | 82 Total number of interventons |
| Standard Balloon Angioplasty | Total Number of Interventions Required to Maintain Access Circuit Patency | 24 Months | 283 Total number of interventons |
| Standard Balloon Angioplasty | Total Number of Interventions Required to Maintain Access Circuit Patency | 9 Months | 124 Total number of interventons |
Secondary
Total Number of Interventions Required to Maintain Target Lesion Patency
The number of target lesion revascularizations per treatment arm through 3 months, 6 months, 9 months, 12 months,18 months, and 24 months post-procedure.
Time frame: 3, 6, 9, 12, 18, and 24 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IN.PACT AV DCB | Total Number of Interventions Required to Maintain Target Lesion Patency | 9 Months | 60 Total number of interventions |
| IN.PACT AV DCB | Total Number of Interventions Required to Maintain Target Lesion Patency | 12 Months | 93 Total number of interventions |
| IN.PACT AV DCB | Total Number of Interventions Required to Maintain Target Lesion Patency | 18 Months | 150 Total number of interventions |
| IN.PACT AV DCB | Total Number of Interventions Required to Maintain Target Lesion Patency | 6 Months | 32 Total number of interventions |
| IN.PACT AV DCB | Total Number of Interventions Required to Maintain Target Lesion Patency | 24 Months | 193 Total number of interventions |
| IN.PACT AV DCB | Total Number of Interventions Required to Maintain Target Lesion Patency | 3 Months | 10 Total number of interventions |
| Standard Balloon Angioplasty | Total Number of Interventions Required to Maintain Target Lesion Patency | 24 Months | 235 Total number of interventions |
| Standard Balloon Angioplasty | Total Number of Interventions Required to Maintain Target Lesion Patency | 3 Months | 19 Total number of interventions |
| Standard Balloon Angioplasty | Total Number of Interventions Required to Maintain Target Lesion Patency | 6 Months | 70 Total number of interventions |
| Standard Balloon Angioplasty | Total Number of Interventions Required to Maintain Target Lesion Patency | 9 Months | 107 Total number of interventions |
| Standard Balloon Angioplasty | Total Number of Interventions Required to Maintain Target Lesion Patency | 12 Months | 144 Total number of interventions |
| Standard Balloon Angioplasty | Total Number of Interventions Required to Maintain Target Lesion Patency | 18 Months | 201 Total number of interventions |