Trial Outcomes & Findings for TurboPower + DCB Treatment of Femoropopliteal De Novo/ Restenotic and In-Stent Restenosis Lesions (NCT NCT03306199)

Results Overview

A Target Lesion Revascularization is defined as any percutaneous or surgical intervention to treat a restenosis or reocclusion in the target lesion

Recruitment status

COMPLETED

Target enrollment

82 participants

Primary outcome timeframe

1 year

Results posted on

2019-04-08

Participant milestones
Measure	Turbo Power + DCB Study participants were included if they had been treated with Turbo Power atherectomy + DCB within the study timeframe.
Overall Study STARTED	82
Overall Study COMPLETED	67
Overall Study NOT COMPLETED	15

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Turbo Power + DCB n=82 Participants Study participants were included if they had been treated with Turbo Power atherectomy + DCB within the study timeframe.
Age, Continuous	70.2 years STANDARD_DEVIATION 13.8 • n=82 Participants
Sex: Female, Male Female	42 Participants n=82 Participants
Sex: Female, Male Male	40 Participants n=82 Participants
Region of Enrollment United States	82 participants n=82 Participants

Timeframe: 1 year

A Target Lesion Revascularization is defined as any percutaneous or surgical intervention to treat a restenosis or reocclusion in the target lesion

Outcome measures
Measure	Turbo Power + DCB n=67 Participants Study participants were included if they had been treated with Turbo Power atherectomy + DCB within the study timeframe.
Number of Participants Free From Target Lesion Revascularization (TLR)	52 Participants

Serious events: 16 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events
Measure	Turbo Power + DCB n=67 participants at risk Study participants were included if they had been treated with Turbo Power atherectomy + DCB within the study timeframe.
Vascular disorders TLR	22.4% 15/67 • Number of events 15 • 1 year TLR, Amputation and Death were collected out to 12 months post-procedure for this retrospective study. Other (Not including serious) adverse events were not captured in this study. Events were collected through review of patient charts within study period.
Cardiac disorders Death	3.0% 2/67 • Number of events 2 • 1 year TLR, Amputation and Death were collected out to 12 months post-procedure for this retrospective study. Other (Not including serious) adverse events were not captured in this study. Events were collected through review of patient charts within study period.
Vascular disorders Amputation	0.00% 0/67 • 1 year TLR, Amputation and Death were collected out to 12 months post-procedure for this retrospective study. Other (Not including serious) adverse events were not captured in this study. Events were collected through review of patient charts within study period.

Adverse event data not reported

Cardiovascular Institute of the South

Phone: (985) 873-5613