Peripheral Arterial Disease
Conditions
Brief summary
A retrospective study to evaluate Turbo Power laser atherectomy + drug coated balloon (DCB) angioplasty for the treatment of femoropopliteal de novo/restenotic lesions and in-stent restenosis (ISR).
Interventions
DEVICELaser Atherectomy
The Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents with adjunctive percutaneous transluminal angioplasty (PTA).
Sponsors
Spectranetics Corporation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All patients treated for femoropopliteal de novo/restenotic lesions or in-stent restenosis using Turbo Power laser atherectomy plus drug coated balloon angioplasty
Exclusion criteria
* Any incomplete data on procedural approach and treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Free From Target Lesion Revascularization (TLR) | 1 year | A Target Lesion Revascularization is defined as any percutaneous or surgical intervention to treat a restenosis or reocclusion in the target lesion |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Turbo Power + DCB Study participants were included if they had been treated with Turbo Power atherectomy + DCB within the study timeframe. | 82 |
| Total | 82 |
Baseline characteristics
| Characteristic | Turbo Power + DCB | — |
|---|---|---|
| Age, Continuous | 70.2 years STANDARD_DEVIATION 13.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 82 participants | — |
| Sex: Female, Male Female | 42 Participants | — |
| Sex: Female, Male Male | 40 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 67 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 16 / 67 |
Outcome results
Primary
Number of Participants Free From Target Lesion Revascularization (TLR)
A Target Lesion Revascularization is defined as any percutaneous or surgical intervention to treat a restenosis or reocclusion in the target lesion
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Turbo Power + DCB | Number of Participants Free From Target Lesion Revascularization (TLR) | 52 Participants |