DA T A P O IN T S Lutonix AV IDE Trial and
In.Pact AV Clinical Trials
Which AV DCB Trial Best Represents Your Patients?
Most common fistula location in DCB arm Published 2 year data?
Patients with stents/stent grafts and previously thrombosed accesses included?
Patients with secondary non-target lesions included?
Required inflation time
CD-TLR definition allowed reintervention on lesions with >70% stenosis without the presence of clinical or physiological abnormalities indicating dialysis access dysfunction?
* As of September 2020, in the U.S. Lutonix™
Lutonix AV IDE Trial
In.Pact AV IDE Trial 61.7% Upper Arm Yes
50.6% Radiocephalic No
Yes Yes 2 minutes No No No 3 minutes Yes
Primary patency defined as ending with a clinically driven re-intervention of the target lesion or access thrombosis. The primary effectiveness analysis for superiority of DCB vs. PTA was not met with a one sided p-value of p = 0.0562. Mean time to TLPP event for subjects with an event was longer for DCBs (321.8 vs. 207.4 d; p< .0001). Percentages reported are derived from Kaplan-Meier analyses. Lutonix Global AV Registry data on file. N=320. At 6 months, treatment with Lutonix™ type, treatment with Lutonix™
035 DCB resulted in a target lesion primary patency (TLPP) rate of 73.9%. Lutonix Global AV Registry on file. N=320. By access intervention until clinically driven reintervention of the target lesion or access thrombosis. Percentages reported are estimated based on Kaplan-Meier estimates. 035 DCB resulted in a TLPP of 78.1% for native fistulas only (240/320) and 61.9% for synthetic (graft) only (80/320). TLPP defined as the interval following index procedure
AV Clinical Trial data on file. N=285. At 6 months, treatment with Lutonix™
035 AV DCB resulted in a primary patency rate of 71.4% versus 63.0% with PTA alone.
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