Peripheral Arterial Disease
Conditions
Keywords
peripheral vascular disease, atherectomy, atherosclerosis, calcified lesions
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.
Interventions
DEVICESilverHawk™ 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.
Sponsors
Medtronic Endovascular
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Revascularization | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Technical Procedural Success | 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 | 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 | at the end of the procedure | Presence of debris in deployed SpiderFx™ embolic protection device |
| Preservation of Run-off Distal to the Filter | 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. |
Participant flow
Recruitment details
133 subjects were enrolled in this study between October 30, 2008 and October 13, 2010. The type of location included hospitals with catheterization labs and/or vascular centers.
Participants by arm
| Arm | Count |
|---|---|
| Study Cohort All participants were treated with SilverHawk™ /TurboHawk™ plaque excision systems, with the SpiderFX™ embolic protection device placed distally. | 133 |
| Total | 133 |
Baseline characteristics
| Characteristic | Study Cohort |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 95 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Age, Continuous | 69.7 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment United States | 133 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 36 / 133 |
| serious Total, serious adverse events | 26 / 133 |
Outcome results
Primary
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).
Time frame: 30 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Cohort | Major Adverse Event Free Rate 30 Days | 93.1 percentage of participants |
Primary
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
Time frame: at the end of the procedure
Population: Number of lesions assessed by the angiographic core lab
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Cohort | Successful Revascularization | 92.0 percentage of lesions |
p-value: <0.05GEE
Secondary
Presence of Debris in Deployed SpiderFx™ Embolic Protection Device
Presence of debris in deployed SpiderFx™ embolic protection device
Time frame: at the end of the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Cohort | Presence of Debris in Deployed SpiderFx™ Embolic Protection Device | 88.4 percentage of deployed filters |
Secondary
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.
Time frame: at the end of the procedure
Population: 115/133 subjects had the required angiographic images to assess this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Cohort | Preservation of Run-off Distal to the Filter | 98.3 percentage of participants |
Secondary
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.
Time frame: at the end of the procedure
Population: 1 lesion not included because there is no angiographic core laboratory post-treatment data available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Cohort | Residual Diameter Stenosis | 64.1 percentage of lesions |
Secondary
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
Time frame: at the end of the procedure
Population: Total patient population minus one patient because there was no angiographic post-treatment core lab data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Cohort | Technical Procedural Success | 88.6 percentage of participants |