Back to resultsStudy of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring peripheral vascular disease, atherectomy, atherosclerosis, calcified lesions
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Atherectomy with embolic protection
Arm Description
All subjects were treated with atherectomy (with SilverHawk or TurboHawk device) in conjunction with embolic protection (SpiderFX device).
Outcomes
Primary Outcome Measures
Successful Revascularization
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
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).
Secondary Outcome Measures
Technical Procedural Success
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
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
Presence of debris in deployed SpiderFx™ embolic protection device
Preservation of Run-off Distal to the Filter
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00733135
Brief Title
Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)
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 Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Endovascular
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multi-center, non-randomized, single arm study of the SilverHawk™ /TurboHawk™ plaque excision systems when used in conjunction with SpiderFX™ embolic protection device in treatment of moderate to severely calcified peripheral arterial disease in the superficial femoral and/or popliteal arteries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
peripheral vascular disease, atherectomy, atherosclerosis, calcified lesions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atherectomy with embolic protection
Arm Type
Other
Arm Description
All subjects were treated with atherectomy (with SilverHawk or TurboHawk device) in conjunction with embolic protection (SpiderFX device).
Intervention Type
Device
Intervention Name(s)
SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device
Intervention Description
Catheter-based excision of moderate to severely calcified plaque located in the SFA and/or popliteal artery.
Primary Outcome Measure Information:
Title
Successful Revascularization
Description
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
Time Frame
at the end of the procedure
Title
Major Adverse Event Free Rate 30 Days
Description
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).
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Technical Procedural Success
Description
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
Time Frame
at the end of the procedure
Title
Residual Diameter Stenosis
Description
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.
Time Frame
at the end of the procedure
Title
Presence of Debris in Deployed SpiderFx™ Embolic Protection Device
Description
Presence of debris in deployed SpiderFx™ embolic protection device
Time Frame
at the end of the procedure
Title
Preservation of Run-off Distal to the Filter
Description
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.
Time Frame
at the end of the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Clair, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Roberts, MD
Organizational Affiliation
Sutter Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
24402764
Citation
Roberts D, Niazi K, Miller W, Krishnan P, Gammon R, Schreiber T, Shammas NW, Clair D; DEFINITIVE Ca(+)(+) Investigators. Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection: final results of the DEFINITIVE Ca(+)(+) trial. Catheter Cardiovasc Interv. 2014 Aug 1;84(2):236-44. doi: 10.1002/ccd.25384. Epub 2014 Feb 5.
Results Reference
result
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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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