Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)
|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.
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|