Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)
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|ClinicalTrials.gov Identifier: NCT00733135|
Recruitment Status : Completed
First Posted : August 12, 2008
Results First Posted : July 4, 2014
Last Update Posted : August 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||133 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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++)|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
Atherectomy with embolic protection
All subjects were treated with atherectomy (with SilverHawk or TurboHawk device) in conjunction with embolic protection (SpiderFX device).
Device: SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device
Catheter-based excision of moderate to severely calcified plaque located in the SFA and/or popliteal artery.
- Successful Revascularization [ Time Frame: at the end of the procedure ]Less than or equal to 50% residual diameter stenosis following plaque excision remaining at the target lesion(s), as adjudicated by the angiographic core laboratory
- Major Adverse Event Free Rate 30 Days [ Time Frame: 30 Days ]MAE was defined as a serious adverse event that results in death, acute myocardial infarction, dissection (grade C or greater), clinical perforation, pseudo-aneurysm, thrombosis, distal embolism (clinically relevant), amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC).
- Technical Procedural Success [ Time Frame: at the end of the procedure ]
Technical Procedural Success was defined as meeting all of the following requirements:
- Less than or equal to 50% residual diameter stenosis at the target lesion(s), as adjudicated by the angiographic core laboratory
- No procedure-related Major Adverse Events (MAE), as adjudicated by the Clinical Events Committee (CEC)
- No device malfunction causing the procedure to be aborted
- Successful delivery and placement of the SpiderFX™ embolic protection device
- Residual Diameter Stenosis [ Time Frame: at the end of the procedure ]This endpoint was met when there was less than 30% residual diameter stenosis following treatment with SilverHawk™ /TurboHawk™ plaque excision systems and any adjunctive therapy (if required), as adjudicated by the angiographic core laboratory.
- Presence of Debris in Deployed SpiderFx™ Embolic Protection Device [ Time Frame: at the end of the procedure ]Presence of debris in deployed SpiderFx™ embolic protection device
- Preservation of Run-off Distal to the Filter [ Time Frame: at the end of the procedure ]Preservation of run-off distal to SpiderFX™ distal embolic protection device was determined by angiography of run-off vessels at the end of the procedure, as adjudicated by the angiographic core laboratory.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733135
|Principal Investigator:||Daniel Clair, MD||The Cleveland Clinic|
|Principal Investigator:||David Roberts, MD||Sutter Medical Center|