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The primary objective for this study is to prove the safety and effectiveness of the Spectranetics Turbo-Elite catheter in atherectomy treatment for infrainguinal arteries with catheter to vessel sizing of at least 50%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Turbo-Elite Atherectomy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Turbo-Elite Laser Catheter | Device | Application of laser energy to remove blockage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint - Mean Reduction in Percent Stenosis | The primary efficacy endpoint target was a mean reduction in percent stenosis of greater than 20% in each study participating at the time of the procedure by Angiographic Core Lab assessment after Turbo-Elite use. A participant showing a mean reduction of 20% was considered a success for the primary efficacy endpoint. | Day 1 |
| Primary Safety Endpoint is Freedom From Major Adverse Event (MAE) | The primary safety endpoint target was 80% of study participant with freedom from a Major Adverse Event (MAE) through 30 day follow-up. A MAE was defined as: all cause death, major amputation in the target limb, or target lesion revascularization. | 30 day follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Final Procedure Residual Stenosis After All Therapy | A Final Procedure Residual Stenosis by visual assessment after all therapy will be accessed acutely during the procedure. | Day 1 |
| Characterization of Adjunctive Therapy Use |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Turbo-Elite Atherectomy | Turbo-Elite Laser Catheter: Application of laser energy to remove blockage |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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One study center enrolled only one study participant, but due to site compliance, data was never collected for the study. This study center was closed due to the non-compliance issue. As a result, 44 participants were enrolled but data is available only for 43 participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Turbo-Elite Atherectomy | Turbo-Elite Laser Catheter: Application of laser energy to remove blockage |
| 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 | Primary Efficacy Endpoint - Mean Reduction in Percent Stenosis | The primary efficacy endpoint target was a mean reduction in percent stenosis of greater than 20% in each study participating at the time of the procedure by Angiographic Core Lab assessment after Turbo-Elite use. A participant showing a mean reduction of 20% was considered a success for the primary efficacy endpoint. | The analysis set is composed of 43 patients, data for primary efficacy analysis was available only for 42 participants. | Posted | Count of Participants | Participants | Day 1 |
|
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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-Elite Atherectomy | Turbo-Elite Laser Catheter: Application of laser energy to remove blockage |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pseudoaneurysm | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arterial Perforation | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicolas Aguirre, Senior Manager, Clinical Operations | Spectranetics, LLC now a part of Philips Image Guided Therapy Devices | 612-297-6655 | nicolas.aguirre@philips.com |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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Adjunctive therapy use will be characterized by frequencies.
| Day 1 |
| Ankle-Brachial Index (ABI) Change From Baseline to 30 Days. | ABI will be assessed at baseline and within 30 days of the procedure. The ABI is calculated ratio of the highest ankle blood pressure to the highest arm blood pressure. The ABI is a non-invasive tool for screening for Peripheral Artery Disease. | Baseline and 30 Days post-procedure |
| Rutherford Class (RCC) Change | Rutherford Class (RCC) will be assessed at baseline and within 30 days of the procedure. The Rutherford-Becker Clinical Categories (RCC) are a classification system of chronic limb ischemia ranging from 0 (asymptomatic; no hemodynamically significant occlusive disease) to 6 (major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable). Lower categories represent better clinical status. | Baseline and 30 days of procedure |
| Freedom From Target Lesion Revascularization (TLR) Through 180 Days. | Freedom from target lesion revascularization (TLR) through 180 days post procedure | Day 180 (6 Months) |
| Declined Addendum ICF |
|
| No response during telephone contact |
|
| Protocol Violation |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| Height (cm) | Mean | Standard Deviation | cm |
|
| Medical History | Count of Participants | Participants |
|
| Smoking Status | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Primary Safety Endpoint is Freedom From Major Adverse Event (MAE) | The primary safety endpoint target was 80% of study participant with freedom from a Major Adverse Event (MAE) through 30 day follow-up. A MAE was defined as: all cause death, major amputation in the target limb, or target lesion revascularization. | Although 40 participants completed 30 day follow-up, data was only available for 39 participants | Posted | Count of Participants | Participants | 30 day follow-up |
|
|
|
| Secondary | Final Procedure Residual Stenosis After All Therapy | A Final Procedure Residual Stenosis by visual assessment after all therapy will be accessed acutely during the procedure. | Posted | Mean | Standard Deviation | Final Residual Stenosis % Per Site | Day 1 |
|
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| Secondary | Characterization of Adjunctive Therapy Use | Adjunctive therapy use will be characterized by frequencies. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Ankle-Brachial Index (ABI) Change From Baseline to 30 Days. | ABI will be assessed at baseline and within 30 days of the procedure. The ABI is calculated ratio of the highest ankle blood pressure to the highest arm blood pressure. The ABI is a non-invasive tool for screening for Peripheral Artery Disease. | Although 43 patients were part of the analysis set, ABI is one of the most often missed assessments during baseline and the follow-up period. Only 40 participants had available ABI data. | Posted | Mean | Standard Deviation | ratio | Baseline and 30 Days post-procedure |
|
|
|
| Secondary | Rutherford Class (RCC) Change | Rutherford Class (RCC) will be assessed at baseline and within 30 days of the procedure. The Rutherford-Becker Clinical Categories (RCC) are a classification system of chronic limb ischemia ranging from 0 (asymptomatic; no hemodynamically significant occlusive disease) to 6 (major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable). Lower categories represent better clinical status. | Refer to participant flow. | Posted | Count of Participants | Participants | Baseline and 30 days of procedure |
|
|
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| Secondary | Freedom From Target Lesion Revascularization (TLR) Through 180 Days. | Freedom from target lesion revascularization (TLR) through 180 days post procedure | Posted | Count of Participants | Participants | Day 180 (6 Months) |
|
|
|
| 5 |
| 43 |
| 14 |
| 43 |
| 2 |
| 43 |
| Arterial Dissection | Vascular disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Restenosis - Target Lesion | Vascular disorders | Systematic Assessment |
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| Restenosis - Target Vessel | Vascular disorders | Systematic Assessment |
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| Restenosis - Non-Target Limb | Vascular disorders | Systematic Assessment |
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| Restenosis - Non-Target Vessel | Vascular disorders | Systematic Assessment |
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| Stroke | Cardiac disorders | Systematic Assessment |
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| Other - Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Other - Cardiac | Cardiac disorders | Systematic Assessment |
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| Embolism | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
|
| Stenting |
|
| Title | Measurements |
|---|---|
|
| Rutherford Class 2 |
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| Rutherford Class 3 |
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| Rutherford Class 4 |
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| Rutherford Class 5 |
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| Rutherford Class 6 |
|