Trial Outcomes & Findings for Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae (NCT NCT02440022)

Last Updated: 2020-05-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

285 participants

Primary outcome timeframe

6 months post index procedure

Results posted on

2020-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	141	144
Overall Study COMPLETED	114	131
Overall Study NOT COMPLETED	27	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lutonix DCB n=141 Participants 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.	Standard Balloon Angioplasty Catheter n=144 Participants 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.	Total n=285 Participants Total of all reporting groups
Age, Continuous	63.6 Years STANDARD_DEVIATION 14.46 • n=5 Participants	61 Years STANDARD_DEVIATION 13.36 • n=7 Participants	62.3 Years STANDARD_DEVIATION 13.95 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	59 Participants n=7 Participants	113 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants	85 Participants n=7 Participants	172 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants	28 Participants n=7 Participants	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	120 Participants n=5 Participants	116 Participants n=7 Participants	236 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	141 participants n=5 Participants	144 participants n=7 Participants	285 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months post index procedure

Outcome measures

Outcome measures
Measure	Lutonix DCB n=141 Participants 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.	Standard Balloon Angioplasty Catheter n=144 Participants 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.
Percentage of Participants With Target Lesion Primary Patency (TLPP) at 6 Months Post Index Procedure	71.4 Percentage of Participants Interval 62.7 to 78.4	63 Percentage of Participants Interval 54.4 to 70.4

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Lutonix DCB n=137 Participants 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.	Standard Balloon Angioplasty Catheter n=144 Participants 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.
Number of Participants With Freedom From Any Serious Adverse Event(s) Involving the AV Access Circuit at 30 Days Post Index Procedure.	130 Participants	138 Participants

SECONDARY outcome

Timeframe: 3, 9, 12, 18, and 24 Months Post Index Procedure

Outcome measures

Outcome measures
Measure	Lutonix DCB n=141 Participants 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.	Standard Balloon Angioplasty Catheter n=144 Participants 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.
Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months At 9 months	58 Percentage of Participants Interval 48.8 to 66.1	46.4 Percentage of Participants Interval 37.8 to 54.5
Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months At 3 months	92.6 Percentage of Participants Interval 86.6 to 95.9	86.7 Percentage of Participants Interval 79.9 to 91.3
Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months At 12 months	44.4 Percentage of Participants Interval 35.3 to 53.1	36 Percentage of Participants Interval 27.9 to 44.2
Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months At 18 months	34 Percentage of Participants Interval 25.3 to 42.9	28.3 Percentage of Participants Interval 20.8 to 36.3
Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months At 24 months	26.9 Percentage of Participants Interval 18.6 to 35.8	24.4 Percentage of Participants Interval 17.2 to 32.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lutonix DCB n=141 Participants 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.	Standard Balloon Angioplasty Catheter n=144 Participants 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.
Percentage of Participants With Device, Procedural and Clinical Success Device Success	100 Percentage of participants	100 Percentage of participants
Percentage of Participants With Device, Procedural and Clinical Success Procedure Success	97.9 Percentage of participants	99.3 Percentage of participants
Percentage of Participants With Device, Procedural and Clinical Success Clinical Success	99.3 Percentage of participants	100 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lutonix DCB n=141 Participants 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.	Standard Balloon Angioplasty Catheter n=144 Participants 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.
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	0 Participants
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	1 Participants
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	4 Participants
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	6 Participants
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	10 Participants
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	13 Participants

SECONDARY outcome

Timeframe: 3, 6, 9, 12, 18 and 24 Months Post Index Procedure

Outcome measures

Outcome measures
Measure	Lutonix DCB n=141 Participants 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.	Standard Balloon Angioplasty Catheter n=144 Participants 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.
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	20 Interventions
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	78 Interventions
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	126 Interventions
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	181 Interventions
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	252 Interventions
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	321 Interventions

SECONDARY outcome

Timeframe: 1, 3, 6, 9, 12, 18 and 24 Months Post Index Procedure

Population: 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.

Outcome measures

Outcome measures
Measure	Lutonix DCB n=141 Participants 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.	Standard Balloon Angioplasty Catheter n=144 Participants 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.
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	1 Participants
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	2 Participants
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	2 Participants
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	2 Participants
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	2 Participants
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	2 Participants
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	2 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Lutonix DCB n=141 Participants 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.	Standard Balloon Angioplasty Catheter n=144 Participants 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.
Number of Participants With Target Lesion Primary Patency (TLPP) by Fiber Pre-Dilation Balloon at 6 Months Post Index Procedure Fiber	57 Participants	48 Participants
Number of Participants With Target Lesion Primary Patency (TLPP) by Fiber Pre-Dilation Balloon at 6 Months Post Index Procedure Non-Fiber	32 Participants	40 Participants

SECONDARY outcome

Timeframe: 3, 6, 9, 12, 18, and 24 Months Post Index Procedure

Outcome measures

Outcome measures
Measure	Lutonix DCB n=141 Participants 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.	Standard Balloon Angioplasty Catheter n=144 Participants 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.
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	11 Interventions
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	64 Interventions
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	93 Interventions
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	137 Interventions
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	184 Interventions
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	223 Interventions

SECONDARY outcome

Timeframe: 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure

Outcome measures

Outcome measures
Measure	Lutonix DCB n=141 Participants 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.	Standard Balloon Angioplasty Catheter n=144 Participants 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.
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	4 Events
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	2 Events
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	3 Events
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	4 Events
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	4 Events
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	4 Events
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	4 Events

Adverse Events

Lutonix DCB

Serious events: 115 serious events

Other events: 97 other events

Deaths: 33 deaths

Standard Balloon Angioplasty Catheter

Serious events: 123 serious events

Other events: 114 other events

Deaths: 26 deaths

Serious adverse events

Other adverse events

Additional Information

Heidi Ronhovde

Becton Dickinson (BD)

Phone: 480-597-8579

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Lutonix DCB n=141 participants at risk 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.	Standard Balloon Angioplasty Catheter n=144 participants at risk 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.
Cardiac disorders Cardiogenic shock	0.00% 0/141 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.69% 1/144 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Cardiac disorders Myocardial infarction	0.71% 1/141 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.00% 0/144 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Infections and infestations Arteriovenous fistula site infection	0.00% 0/141 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.69% 1/144 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Infections and infestations Haematoma infection	0.00% 0/141 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.69% 1/144 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/141 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.69% 1/144 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Injury, poisoning and procedural complications Arteriovenous fistula aneurysm	4.3% 6/141 • Number of events 6 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	4.2% 6/144 • Number of events 6 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Injury, poisoning and procedural complications Arteriovenous fistula occlusion	0.00% 0/141 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	1.4% 2/144 • Number of events 2 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	66.7% 94/141 • Number of events 94 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	76.4% 110/144 • Number of events 110 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Injury, poisoning and procedural complications Arteriovenous fistula site haematoma	0.00% 0/141 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.69% 1/144 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Injury, poisoning and procedural complications Arteriovenous fistula site haemorrhage	0.71% 1/141 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.00% 0/144 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	9.2% 13/141 • Number of events 13 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	11.8% 17/144 • Number of events 17 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Injury, poisoning and procedural complications Excoriation	0.00% 0/141 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.00% 0/144 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Injury, poisoning and procedural complications Seroma	0.00% 0/141 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.69% 1/144 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Injury, poisoning and procedural complications Vascular graft complication	0.71% 1/141 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.00% 0/144 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Injury, poisoning and procedural complications Vascular graft thrombosis	1.4% 2/141 • Number of events 2 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.00% 0/144 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.71% 1/141 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.69% 1/144 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/141 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	1.4% 2/144 • Number of events 2 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Skin and subcutaneous tissue disorders Skin ulcer	0.71% 1/141 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.69% 1/144 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Skin and subcutaneous tissue disorders Skin ulcer haemorrhage	0.71% 1/141 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.69% 1/144 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Vascular disorders Brachiocephalic vein stenosis	1.4% 2/141 • Number of events 2 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	2.8% 4/144 • Number of events 4 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Vascular disorders Deep vein thrombosis	0.00% 0/141 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.69% 1/144 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Vascular disorders Hypertension	0.00% 0/141 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.00% 0/144 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Vascular disorders Hypovolaemic shock	0.71% 1/141 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.00% 0/144 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Vascular disorders Steal syndrome	0.71% 1/141 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.69% 1/144 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Vascular disorders Subclavian vein thrombosis	0.71% 1/141 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.00% 0/144 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Vascular disorders Vascular calcification	0.00% 0/141 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.00% 0/144 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Vascular disorders Vasospasm	0.71% 1/141 • Number of events 1 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	0.00% 0/144 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.
Vascular disorders Venous occlusion	6.4% 9/141 • Number of events 9 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.	9.7% 14/144 • Number of events 14 • At 24 months Post Index Procedure The Serious Adverse Events (SAEs) presented reflect Subjects with SAEs by body system and preferred term (CEC adjudicated) at 24 months post index procedure.