Trial Outcomes & Findings for FLAIR™ Delivery System Study (NCT NCT00614315)

Results Overview

defined as deployment of the implant to the intended location, assessed at the time of the index procedure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Measured at the time of implantation (Day 0)

Results posted on

2017-02-28

Participant milestones
Measure	FLAIR Endovascular Stent Graft Patients treated with the FLAIR Endovascular Stent Graft
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Withdrawal data not reported

FLAIR™ Delivery System Study

Baseline characteristics by cohort
Measure	FLAIR Endovascular Stent Graft n=30 Participants Patients treated with the FLAIR Endovascular Stent Graft
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age, Continuous	64.8 years STANDARD_DEVIATION 15.14 • n=5 Participants
Gender Female	17 Participants n=5 Participants
Gender Male	13 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

Timeframe: Measured at the time of implantation (Day 0)

defined as deployment of the implant to the intended location, assessed at the time of the index procedure.

Outcome measures
Measure	FLAIR Endovascular Stent Graft n=30 Participants Patients treated with the FLAIR Endovascular Stent Graft
Technical Success for Delivery	100 Percentage of successful implantations

Timeframe: Index Procedure to 30 days

Device/Procedure-related adverse events from the index procedure through 30 days post procedure

Outcome measures
Measure	FLAIR Endovascular Stent Graft n=30 Participants Patients treated with the FLAIR Endovascular Stent Graft
Number of Device/Procedure-related Adverse Events(Safety of Delivery)	1 Number of Device/Procedure events

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	FLAIR Endovascular Stent Graft n=30 participants at risk Patients treated with the FLAIR Endovascular Stent Graft
Blood and lymphatic system disorders Thrombosis of Access Circuit	10.0% 3/30 • Number of events 3 • 30 days post implantation

Bard Peripheral Vascular, Inc.

Phone: 480-303-2644