Table 3.

Intervention, drug, biologic, and device trial categories with suggested end points

Number	Goal for Clinical Trial	Primary End Points	Secondary End Pointsa
1	Use IDBD to facilitate the creation of a phase 1 AV access (creation)b	Development of a phase 1 AV access (creation)	1–5
2	Use of an IDBD to facilitate the maturation of a phase 1 AV access to a phase 2 AV access (maturation)	Development of a phase 2 AV access (maturation)	1–8
3	Use of an IDBD to facilitate the conversion of a phase 2 AV access to a phase 3 AV access (clinical use, initial)	Development of a phase 3 access (clinical use, initial)	2–8
4	Use of an IDBD (the intervention) to address the problem of malfunction or complication occurring in a phase 4 AV access (clinical use, sustained)
a	Use of an IDBD to prevent clinically significant stenosis in the hemodialysis access circuit	Primary patency of AV access over a specified period	2–5, 9–11
b	Use of an IDBD to treat clinically significant stenosis (the target lesion) occurring within the hemodialysis access circuit	Postintervention primary patency of target lesion over a specified period	2–5, 7–14
c	Use of an IDBD to prevent recurrent clinically significant stenosis in the hemodialysis access circuit	Postintervention primary patency of target zone over a 12-mo period (a different period may be appropriate if justified in trial design)	2–5, 7–14
d	Use of an IDBD to prevent thrombosis of an AV access	Postintervention primary patency of AV access over a 12-mo period (a different time period may be appropriate if justified in trial design)	2–5, 7–14
5	Use of an IDBD (the intervention) to prevent or treat a targeted complication of an AV access (aneurysm formation, dialysis access steal syndrome, infection, etc.)	Freedom from targeted complication over a 12-mo period (a different time period may be appropriate if justified in trial design)	2–5, 7–14
6	Use of an IDBD (the intervention) to prolong phase 4 of AV access (clinical use, sustained)	Cumulative patency of hemodialysis access circuit or time to occurrence of an event that would require an IDBD intervention	2–5, 9–11, 14
7	Use of an IDBD (the intervention) to prevent or improve a specific complication or adverse outcome reported by the patient related to an AV access (pain of cannulation, convenience of cannulation, cosmetic appearance, etc.)	Failure to develop targeted patient-reported specific complication or adverse outcome over a specified period	2–5, 9–11, 14–16

IDBD, intervention, drug, biologic, device; AV, arteriovenous.

^aSecondary end points: 1=Development of next phase in of AV-access life cycle. 2=Additional number of IDBD interventions required to achieve primary end point. 3=Incidence and types of IDBD complications. 4=Quality-of-life assessment of patients related to IDBD intervention and primary outcome. 5=Utilization of health care resources required to achieve primary end point. 6=Time required to achieve primary end point. 7=Incidence of catheter use. 8=Duration of hemodialysis catheter use and time that catheter is in place. 9=Postintervention primary patency of hemodialysis access circuit over specified period. 10=Postintervention cumulative patency of hemodialysis access circuit over specified period. 11=Time to access abandonment. 12=Postintervention assisted primary patency of target lesion over a specified period. 13=Postintervention cumulative patency of target lesion over specified period. 14=Postintervention assisted primary patency of hemodialysis access circuit over specified period. 15=Change in severity of the specific complication or adverse outcome. 16=Time to recurrence of a specific complication or adverse outcome.

^bCompared with the adult CKD population, the accomplishment of this end point may be different for pediatric patients, requiring IDBD interventions that are specifically targeted to this age group.