Arteriovenous Fistula
Conditions
Brief summary
This prospective, global, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Lutonix 035 AV Drug Coated Balloon PTA Catheter compared to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.
Interventions
COMBINATION_PRODUCTLutonix DCB
DEVICEStandard Balloon Angioplasty Catheter
PROCEDUREPercutaneous Transluminal Angiography
Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
Sponsors
C. R. Bard
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. Age ≥21 years; 2. The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF); 3. Arteriovenous fistula located in the arm; 4. Native AV fistula was created ≥30 days prior to the index procedure and has undergone one or more hemodialysis sessions; 5. Venous stenosis of an AV fistula with the target lesion located from the anastomosis to the axillosubclavian junction and an abnormality attributable to the stenosis as defined by K/DOQI guidelines.; 6. Successful pre-dilation of the target lesion with a percutaneous transluminal angioplasty (PTA) balloon; 7. Intended target lesion.
Exclusion criteria
1. Women who are pregnant, lactating, or planning on becoming pregnant during the study; 2. Hemodialysis access is located in the leg; 3. Subject has more than two lesions in the access circuit; 4. Subject has a secondary non-target lesion that cannot be successfully treated; 5. Target lesion is located central to the axillosubclavian junction; 6. The subject has a secondary lesion located in the central venous system (central to the axillosubclavian junction); 7. A thrombosed access; 8. Surgical revision of the access site planned; 9. Recent prior surgical interventions of the access site; 10. Other planned treatment during the index procedure; 11. Known contraindication (including allergic reaction) or sensitivity to iodinated contrast media, that cannot be adequately managed with pre-and post-procedure medication; 12. Known contraindication (including allergic reaction) or sensitivity to paclitaxel. 13. Subjects who are taking immunosuppressive therapy or are routinely taking ≥10mg of prednisone per day; 14. Subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be noncompliant with the protocol or confound the data interpretation; 15. Subject has a life expectancy \<12 months; 16. Anticipated for a kidney transplant; 17. Anticipated conversion to peritoneal dialysis; 18. Subject has a stent located in the target or secondary non target lesion; 19. Subject has an infected AV access or systemic infection; 20. Currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Target Lesion Primary Patency (TLPP) at 6 Months Post Index Procedure | 6 months post index procedure | Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. Target Lesion Primary Patency (TLPP) ends with a clinically driven re-intervention of the target lesion or access thrombosis. |
| Number of Participants With Freedom From Any Serious Adverse Event(s) Involving the AV Access Circuit at 30 Days Post Index Procedure. | 30 Days Post Index Procedure | The primary safety endpoint is freedom from localized or systemic serious adverse events through 30 days that reasonably suggests the involvement of the AV access circuit (CEC adjudicated). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Device, Procedural and Clinical Success | Device and Procedural Success: At time of Index Procedure; Clinical Success: at 1st session of dialysis following index procedure | * Device Success: Successful delivery to the target lesion, deployment, and retrieval at index procedure. * Procedural Success: At least one indicator of hemodynamic success (e.g., physical examination with restoration of a thrill, direct measurement of flow) in the absence of peri-procedural (index procedure and through hospital stay) Serious Adverse Device Effects (SADEs). * Clinical Success: The resumption of dialysis for at least one session after the index procedure. |
| Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | 3, 6, 9, 12, 18 and 24 Months Post Index Procedure | Index access site abandonment refers to an abandonment due to either receiving a kidney transplant, converting to Peritoneal Dialysis, or a new access site being created. |
| Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | 3, 6, 9, 12, 18 and 24 Months Post Index Procedure | — |
| Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated) | 1, 3, 6, 9, 12, 18 and 24 Months Post Index Procedure | Events adjudicated as 'definitely related' and 'possibly related' by the CEC were combined in all analyses and are displayed as 'related' in this report. |
| Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | — |
| Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | — |
| Number of Participants With Target Lesion Primary Patency (TLPP) by Fiber Pre-Dilation Balloon at 6 Months Post Index Procedure | 6 Months Post Index Procedure | Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. Target Lesion Primary Patency (TLPP) ends with a clinically driven re-intervention of the target lesion or access thrombosis. |
| Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months | 3, 9, 12, 18, and 24 Months Post Index Procedure | Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. Target Lesion Primary Patency (TLPP) ends with a clinically driven re-intervention of the target lesion or access thrombosis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lutonix DCB Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon.
Lutonix DCB
Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. | 141 |
| Standard Balloon Angioplasty Catheter Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.
Standard Balloon Angioplasty Catheter
Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. | 144 |
| Total | 285 |
Baseline characteristics
| Characteristic | Lutonix DCB | Standard Balloon Angioplasty Catheter | Total |
|---|---|---|---|
| Age, Continuous | 63.6 Years STANDARD_DEVIATION 14.46 | 61 Years STANDARD_DEVIATION 13.36 | 62.3 Years STANDARD_DEVIATION 13.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 28 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 120 Participants | 116 Participants | 236 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 141 participants | 144 participants | 285 participants |
| Sex: Female, Male Female | 54 Participants | 59 Participants | 113 Participants |
| Sex: Female, Male Male | 87 Participants | 85 Participants | 172 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 33 / 141 | 26 / 144 |
| other Total, other adverse events | 97 / 141 | 114 / 144 |
| serious Total, serious adverse events | 115 / 141 | 123 / 144 |
Outcome results
Primary
Number of Participants With Freedom From Any Serious Adverse Event(s) Involving the AV Access Circuit at 30 Days Post Index Procedure.
The primary safety endpoint is freedom from localized or systemic serious adverse events through 30 days that reasonably suggests the involvement of the AV access circuit (CEC adjudicated).
Time frame: 30 Days Post Index Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lutonix DCB | Number of Participants With Freedom From Any Serious Adverse Event(s) Involving the AV Access Circuit at 30 Days Post Index Procedure. | 130 Participants |
| Standard Balloon Angioplasty Catheter | Number of Participants With Freedom From Any Serious Adverse Event(s) Involving the AV Access Circuit at 30 Days Post Index Procedure. | 138 Participants |
Comparison: H0: The primary safety rate p1 in the DCB treatment group through 30 days post index procedure is inferior to that p2 of the PTA treatment group. (i.e. p1 ≤ p2 - δ)~H1: The primary safety rate p1 in the DCB treatment group through 30 days post index procedure is non-inferior to that p2 of the PTA treatment group. (i.e. p1 \> p2 - δ)p-value: 0.002Binary Analysis
Primary
Percentage of Participants With Target Lesion Primary Patency (TLPP) at 6 Months Post Index Procedure
Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. Target Lesion Primary Patency (TLPP) ends with a clinically driven re-intervention of the target lesion or access thrombosis.
Time frame: 6 months post index procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lutonix DCB | Percentage of Participants With Target Lesion Primary Patency (TLPP) at 6 Months Post Index Procedure | 71.4 Percentage of Participants |
| Standard Balloon Angioplasty Catheter | Percentage of Participants With Target Lesion Primary Patency (TLPP) at 6 Months Post Index Procedure | 63 Percentage of Participants |
p-value: 0.0562Kaplan-Meier
Secondary
Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure
Time frame: 3, 6, 9, 12, 18 and 24 Months Post Index Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lutonix DCB | Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 3 months | 21 Interventions |
| Lutonix DCB | Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 9 months | 115 Interventions |
| Lutonix DCB | Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 18 months | 228 Interventions |
| Lutonix DCB | Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 12 months | 164 Interventions |
| Lutonix DCB | Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 24 months | 291 Interventions |
| Lutonix DCB | Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 6 months | 68 Interventions |
| Standard Balloon Angioplasty Catheter | Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 24 months | 321 Interventions |
| Standard Balloon Angioplasty Catheter | Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 12 months | 181 Interventions |
| Standard Balloon Angioplasty Catheter | Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 3 months | 20 Interventions |
| Standard Balloon Angioplasty Catheter | Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 6 months | 78 Interventions |
| Standard Balloon Angioplasty Catheter | Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 18 months | 252 Interventions |
| Standard Balloon Angioplasty Catheter | Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 9 months | 126 Interventions |
Secondary
Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure
Time frame: 3, 6, 9, 12, 18, and 24 Months Post Index Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lutonix DCB | Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 3 months | 19 Interventions |
| Lutonix DCB | Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 6 months | 44 Interventions |
| Lutonix DCB | Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 9 months | 66 Interventions |
| Lutonix DCB | Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 12 months | 113 Interventions |
| Lutonix DCB | Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 18 months | 160 Interventions |
| Lutonix DCB | Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 24 months | 208 Interventions |
| Standard Balloon Angioplasty Catheter | Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 18 months | 184 Interventions |
| Standard Balloon Angioplasty Catheter | Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 3 months | 11 Interventions |
| Standard Balloon Angioplasty Catheter | Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 12 months | 137 Interventions |
| Standard Balloon Angioplasty Catheter | Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 6 months | 64 Interventions |
| Standard Balloon Angioplasty Catheter | Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 24 months | 223 Interventions |
| Standard Balloon Angioplasty Catheter | Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 9 months | 93 Interventions |
Secondary
Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure
Index access site abandonment refers to an abandonment due to either receiving a kidney transplant, converting to Peritoneal Dialysis, or a new access site being created.
Time frame: 3, 6, 9, 12, 18 and 24 Months Post Index Procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lutonix DCB | Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 3 months | 3 Participants |
| Lutonix DCB | Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 6 months | 5 Participants |
| Lutonix DCB | Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 9 months | 12 Participants |
| Lutonix DCB | Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 12 months | 13 Participants |
| Lutonix DCB | Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 18 months | 14 Participants |
| Lutonix DCB | Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 24 months | 22 Participants |
| Standard Balloon Angioplasty Catheter | Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 18 months | 10 Participants |
| Standard Balloon Angioplasty Catheter | Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 3 months | 0 Participants |
| Standard Balloon Angioplasty Catheter | Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 12 months | 6 Participants |
| Standard Balloon Angioplasty Catheter | Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 6 months | 1 Participants |
| Standard Balloon Angioplasty Catheter | Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 24 months | 13 Participants |
| Standard Balloon Angioplasty Catheter | Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 9 months | 4 Participants |
Secondary
Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated)
Events adjudicated as 'definitely related' and 'possibly related' by the CEC were combined in all analyses and are displayed as 'related' in this report.
Time frame: 1, 3, 6, 9, 12, 18 and 24 Months Post Index Procedure
Population: CEC adjudicated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lutonix DCB | Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated) | At 6 months | 7 Participants |
| Lutonix DCB | Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated) | At 12 months | 7 Participants |
| Lutonix DCB | Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated) | At 3 months | 7 Participants |
| Lutonix DCB | Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated) | At 18 months | 7 Participants |
| Lutonix DCB | Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated) | At 9 months | 7 Participants |
| Lutonix DCB | Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated) | At 24 months | 7 Participants |
| Lutonix DCB | Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated) | At 1 month | 5 Participants |
| Standard Balloon Angioplasty Catheter | Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated) | At 24 months | 2 Participants |
| Standard Balloon Angioplasty Catheter | Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated) | At 1 month | 1 Participants |
| Standard Balloon Angioplasty Catheter | Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated) | At 3 months | 2 Participants |
| Standard Balloon Angioplasty Catheter | Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated) | At 6 months | 2 Participants |
| Standard Balloon Angioplasty Catheter | Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated) | At 9 months | 2 Participants |
| Standard Balloon Angioplasty Catheter | Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated) | At 12 months | 2 Participants |
| Standard Balloon Angioplasty Catheter | Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated) | At 18 months | 2 Participants |
Secondary
Number of Participants With Target Lesion Primary Patency (TLPP) by Fiber Pre-Dilation Balloon at 6 Months Post Index Procedure
Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. Target Lesion Primary Patency (TLPP) ends with a clinically driven re-intervention of the target lesion or access thrombosis.
Time frame: 6 Months Post Index Procedure
Population: The (n) analyzed depended on the number of participants for which data was available at the time of analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lutonix DCB | Number of Participants With Target Lesion Primary Patency (TLPP) by Fiber Pre-Dilation Balloon at 6 Months Post Index Procedure | Fiber | 57 Participants |
| Lutonix DCB | Number of Participants With Target Lesion Primary Patency (TLPP) by Fiber Pre-Dilation Balloon at 6 Months Post Index Procedure | Non-Fiber | 32 Participants |
| Standard Balloon Angioplasty Catheter | Number of Participants With Target Lesion Primary Patency (TLPP) by Fiber Pre-Dilation Balloon at 6 Months Post Index Procedure | Fiber | 48 Participants |
| Standard Balloon Angioplasty Catheter | Number of Participants With Target Lesion Primary Patency (TLPP) by Fiber Pre-Dilation Balloon at 6 Months Post Index Procedure | Non-Fiber | 40 Participants |
p-value: 0.716Regression, Cox
Secondary
Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure
Time frame: 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lutonix DCB | Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 3 Months | 11 Events |
| Lutonix DCB | Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 12 Months | 11 Events |
| Lutonix DCB | Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 1 month | 8 Events |
| Lutonix DCB | Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 18 Months | 11 Events |
| Lutonix DCB | Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 6 Months | 11 Events |
| Lutonix DCB | Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 24 Months | 11 Events |
| Lutonix DCB | Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 9 Months | 11 Events |
| Standard Balloon Angioplasty Catheter | Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 24 Months | 4 Events |
| Standard Balloon Angioplasty Catheter | Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 1 month | 2 Events |
| Standard Balloon Angioplasty Catheter | Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 3 Months | 3 Events |
| Standard Balloon Angioplasty Catheter | Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 9 Months | 4 Events |
| Standard Balloon Angioplasty Catheter | Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 12 Months | 4 Events |
| Standard Balloon Angioplasty Catheter | Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 18 Months | 4 Events |
| Standard Balloon Angioplasty Catheter | Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure | At 6 Months | 4 Events |
Secondary
Percentage of Participants With Device, Procedural and Clinical Success
* Device Success: Successful delivery to the target lesion, deployment, and retrieval at index procedure. * Procedural Success: At least one indicator of hemodynamic success (e.g., physical examination with restoration of a thrill, direct measurement of flow) in the absence of peri-procedural (index procedure and through hospital stay) Serious Adverse Device Effects (SADEs). * Clinical Success: The resumption of dialysis for at least one session after the index procedure.
Time frame: Device and Procedural Success: At time of Index Procedure; Clinical Success: at 1st session of dialysis following index procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lutonix DCB | Percentage of Participants With Device, Procedural and Clinical Success | Device Success | 100 Percentage of participants |
| Lutonix DCB | Percentage of Participants With Device, Procedural and Clinical Success | Procedure Success | 97.9 Percentage of participants |
| Lutonix DCB | Percentage of Participants With Device, Procedural and Clinical Success | Clinical Success | 99.3 Percentage of participants |
| Standard Balloon Angioplasty Catheter | Percentage of Participants With Device, Procedural and Clinical Success | Device Success | 100 Percentage of participants |
| Standard Balloon Angioplasty Catheter | Percentage of Participants With Device, Procedural and Clinical Success | Procedure Success | 99.3 Percentage of participants |
| Standard Balloon Angioplasty Catheter | Percentage of Participants With Device, Procedural and Clinical Success | Clinical Success | 100 Percentage of participants |
Secondary
Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months
Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. Target Lesion Primary Patency (TLPP) ends with a clinically driven re-intervention of the target lesion or access thrombosis.
Time frame: 3, 9, 12, 18, and 24 Months Post Index Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lutonix DCB | Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months | At 9 months | 58 Percentage of Participants |
| Lutonix DCB | Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months | At 18 months | 34 Percentage of Participants |
| Lutonix DCB | Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months | At 12 months | 44.4 Percentage of Participants |
| Lutonix DCB | Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months | At 24 months | 26.9 Percentage of Participants |
| Lutonix DCB | Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months | At 3 months | 92.6 Percentage of Participants |
| Standard Balloon Angioplasty Catheter | Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months | At 24 months | 24.4 Percentage of Participants |
| Standard Balloon Angioplasty Catheter | Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months | At 3 months | 86.7 Percentage of Participants |
| Standard Balloon Angioplasty Catheter | Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months | At 9 months | 46.4 Percentage of Participants |
| Standard Balloon Angioplasty Catheter | Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months | At 12 months | 36 Percentage of Participants |
| Standard Balloon Angioplasty Catheter | Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months | At 18 months | 28.3 Percentage of Participants |