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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Atherectomy | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients are recruited from the investigator's general patient population, and they must meet the inclusion/exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Turbo Power + DCB | Study participants were included if they had been treated with Turbo Power atherectomy + DCB within the study timeframe. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Turbo Power + DCB | Study participants were included if they had been treated with Turbo Power atherectomy + DCB within the study timeframe. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 1 year |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Turbo Power + DCB | Study participants were included if they had been treated with Turbo Power atherectomy + DCB within the study timeframe. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| TLR | Vascular disorders | Systematic Assessment | Target Lesion Revascularization |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Team Leader | Cardiovascular Institute of the South | (985) 873-5613 | Deanna.Benoit@cardio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2018 | Nov 20, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| 2 |
| 67 |
| 16 |
| 67 |
| 0 |
| 0 |
| Death | Cardiac disorders | Systematic Assessment |
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| Amputation | Vascular disorders | Systematic Assessment |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |