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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00733135 |
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Date of registration:
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08/08/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)
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Scientific title:
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Determination of Safety and Effectiveness of the SilverHawk™ Peripheral Plaque Excision System for Calcium (SilverHawk LS-C) and the SpiderFX™ Embolic Protection Device for the Treatment of Calcified Peripheral Arterial Disease in the Superficial Femoral and/or the Popliteal Arteries (DEFINITIVE Ca++) |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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133 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00733135 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Daniel Clair, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Cleveland Clinic |
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Name:
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David Roberts, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sutter Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Provides written informed consent
- Willing to comply with follow-up evaluations at specified times
- Has leg pain due to peripheral arterial disease
- Disease located within the femoropopliteal artery
- Moderate to severe calcification
Exclusion Criteria:
- Previously implanted stent(s) or stent graft(s) in target leg
- Life expectancy less than 12 months
- Has any planned surgical or endovascular intervention of target vessel 30 days before
or after index procedure
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Peripheral Arterial Disease
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Intervention(s)
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Device: SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device
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Primary Outcome(s)
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Successful Revascularization
[Time Frame: at the end of the procedure]
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Major Adverse Event Free Rate 30 Days
[Time Frame: 30 Days]
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Secondary Outcome(s)
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Residual Diameter Stenosis
[Time Frame: at the end of the procedure]
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Presence of Debris in Deployed SpiderFx™ Embolic Protection Device
[Time Frame: at the end of the procedure]
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Preservation of Run-off Distal to the Filter
[Time Frame: at the end of the procedure]
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Technical Procedural Success
[Time Frame: at the end of the procedure]
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Secondary ID(s)
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FHT-P-07-003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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