An observational study in Peripheral Arterial Disease, sponsored by Spectranetics Corporation. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-04-08.
Sponsored by Spectranetics Corporation · Observational
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).
Patients are recruited from the investigator's general patient population, and they must meet the inclusion/exclusion criteria.
Exclusion Criteria:
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).
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
| Milestone | Turbo Power + DCB |
|---|---|
| Started | 82 |
| Completed | 67 |
| Not completed | 15 |
A Target Lesion Revascularization is defined as any percutaneous or surgical intervention to treat a restenosis or reocclusion in the target lesion
| Participants | Turbo Power + DCB |
|---|---|
| Number of Participants Free From Target Lesion Revascularization (TLR) | 52 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Turbo Power + DCB | 2/67 (3%) | 16/67 (23.9%) | — |
| Event | Turbo Power + DCB |
|---|---|
| TLRVascular disorders | 15/67 |
| DeathCardiac disorders | 2/67 |
| AmputationVascular disorders | 0/67 |
| Age, Continuous(years) | Turbo Power + DCB |
|---|---|
| Mean | 70.2 ± 13.8 |
| Sex: Female, Male(Participants) | Turbo Power + DCB |
|---|---|
| Female | 42 |
| Male | 40 |
| Race and Ethnicity Not Collected(Participants) | Turbo Power + DCB |
|---|
| Region of Enrollment(participants) | Turbo Power + DCB |
|---|---|
| United States | 82 |
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Plan to share: No
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Spectranetics Corporation