Peripheral Arterial DiseaseNCT00883246
Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)
A study testing SilverHawk & TurboHawk Peripheral Plaque Excision System in people with Peripheral Arterial Disease and Claudication, run by Medtronic Endovascular.
Trial summary
The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- What is being tested?
- SilverHawk & TurboHawk Peripheral Plaque Excision System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a Rutherford Clinical Category Score of 1 - 6.
- Has evidence of ≥ 50% stenosis or occlusion in the superficial femoral, popliteal, anterior tibial, posterior tibial and/or peroneal arteries, confirmed by angiography.
- Has identifiable distal target vessel which upon completion of the intervention, is anticipated to provide re-constitution of blood flow to the foot.
- Exchangeable guidewire must cross lesion(s), with ability of catheter to cross lesion.
- Each discrete target lesion's length is ≤ 20 cm.
- Reference vessel diameter is ≥ 1.5 mm and ≤ 7 mm.
Who cannot join
- Has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure.
- Has any planned surgical intervention or endovascular procedure within 30 days after the index procedure.
- Has had a previous peripheral bypass affecting the target limb.
- Has end-stage renal disease defined as undergoing hemodialysis for kidney failure.
- Has presence of severe calcification in target lesion(s).
- Has in-stent restenosis of the target lesion.
Show all 11Show fewer
- Has an aneurysmal target vessel.
- Has significant stenosis or occlusion of inflow tract that has not been revascularized prior to treatment of the target vessel.
- Has perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to enrollment.
- Has disease that precludes safe advancement of the SilverHawk/TurboHawk device to the target lesion(s).
- Has had a previous amputation above the metatarsal line on the target limb.
About this study
Official title: Determination of Effectiveness of SilverHawk Peripheral Plaque Excision (SilverHawk Device) for the Treatment of Infrainguinal Vessels/Lower Extremities
The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.
- Being tested
- SilverHawk & TurboHawk Peripheral Plaque Excision System
- Keywords
- PAD
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilverHawk & TurboHawk Peripheral Plaque Excision SystemDevice
Also called SilverHawk (Atherectomy), TurboHawk (Atherectomy)
Removal of atherosclerotic plaque from artery walls.
| Study group | Role | What they receive |
|---|---|---|
| Atherectomy | Other | All patients enrolled in this single-arm study were treated with directional atherectomy. Receives: Device: SilverHawk & TurboHawk Peripheral Plaque Excision System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency Rate (in Patients Treated for Claudication RCC 1-3)
The primary endpoint analysis for claudication subjects was primary patency rate at one year, defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who had claudication (RCC of 1 - 3) at time of enrollment.
Measured: One year
Amputation-Free Survival at 1 Year (in Patients Treated for Critical Limb Ischemia RCC 4-6)
The primary endpoint for CLI was amputation-free survival at one year, defined as freedom from a major, unplanned amputation of the target limb through the 1-year visit in subjects who have CLI (RCC 4 - 6) at time of enrollment.
Measured: One Year
Secondary outcomes (12)
Device Success (in All Patients Enrolled)
Device success was defined as ≤ 30% residual stenosis following use of the SilverHawk device, as measured by angiography, without adjunctive endovascular interventions or periprocedural complications.
Measured: Immediately following use of the SilverHawk device
Procedural Success (in All Patients Enrolled)
Procedure success was defined as ≤ 30% residual stenosis following use of SilverHawk device and adjunctive endovascular interventions (if required) as measured by angiography without periprocedural complications.
Measured: Immediately following use of the SilverHawk and adjunctive devices
Major Adverse Event Rate (in All Patients Enrolled)
Major Adverse Event Rate (MAE) at 30 Days was defined as clinically-driven target vessel revascularization (TVR), major unplanned amputation of treated limb, or all-cause mortality within 30 days post procedure, as classified by the Clinical Events Committee (CEC).
Measured: 30 Days
Major Adverse Event Rate (in All Patients Enrolled)
Major Adverse Event Rate at One Year was defined as clinically-driven target vessel revascularization, major unplanned amputation of the treated limb, or all-cause mortality within one year, as classified by the Clinical Events Committee (CEC).
Measured: One Year
Improvement in Walking Impairment Questionnaire Score (in Patients Treated for Claudication RCC 1-3)
WIQ includes a measurement for walking distance, walking speed, and climbing stairs collected at baseline and one year, presented for subjects who have claudication. The Walking Improvement Questionnaire (WIQ) is a validated method to assess objective improvement in functional walking ability of subjects with intermittent claudication. Difficulty walking a distance was self-assessed at baseline by the patient (prior to treatment) and at the one year follow up visit. Speed and stair climbing ability were assessed by the treating physician. Scale ranges from 0 (minimum) to 100 (maximum), with larger numbers representing better outcomes. An increase in WIQ scores at 1 year represents an improvement over baseline.
Measured: Baseline and 1 Year
Improvement in Rutherford Clinical Category (in All Patients Enrolled)
Change in RCC at One Year was assessed and percentage of subjects with an improvement in clinical status indicated by a decrease of one or more in RCC at one year compared to baseline, that is attributable to the treated limb (in cases of bilateral disease), was calculated.
Measured: 1 Year
Ankle-Brachial Index (in All Patients Enrolled)
Change in Ankle-Brachial Index at One Year was calculated and percentage of subjects with an increase (improvement) in the ankle-brachial index (ABI) at one year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9 was calculated.
Measured: 1 Year
Secondary Patency (in Patients Treated for Claudication RCC 1-3)
Secondary patency was defined as measured by duplex ultrasound peak systolic velocity ratio ≤ 3.5 maintained by repeat percutaneous intervention in subjects who have claudication; estimated as freedom from loss of patency by the Kaplan-Meier method at one year.
Measured: One Year
Primary Patency (in Patients Treated for Critical Limb Ischemia RCC 4-6)
The primary patency for CLI was defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who have CLI at time of enrollment
Measured: One Year
Amputation-Free Survival (in Patients Treated for Claudication RCC 1-3)
Amputation-Free Survival in Claudicants at One Year was defined as freedom from a major, unplanned amputation of the target limb through the one year visit in subjects who have claudication at time of enrollment.
Measured: One Year
Improvement in Wound Healing (in Patients Treated for Critical Limb Ischemia and With Wounds RCC 5-6)
Wound healing at three months was defined as a decrease of at least one Wagner Classification grade of the wound at three months compared to baseline in subjects who have Rutherford Clinical Category score of 5 or 6 at the time of enrollment.
Measured: 3 months
Alternative Patency Rate (Peak Systolic Velocity ≤ 2.4) at 1 Year (in Patients Treated for Claudication RCC 1-3)
Defined by the duplex ultrasound measurement of peak systolic velocity ration ≤ 2.4 at the target lesion (s) with no clinically-driven re- intervention with the treated segment in subjects who have claudication at time of enrollment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lawrence Garcia, MD, Principal investigator, St. Elizabeth's Medical Center, Tuft's University School of MedicineJames McKinsey, MD, Principal investigator, The New York Presbyterian/Columbia UniversityProfessor Thomas Zeller, Principal investigator, Herz-Zentrum Bad Krozingen Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883246
- Sponsor's protocol ID
- DEFINITIVE LE
- Status last verified
- May 2019
- First submitted
- 16 Apr 2009
- Last updated
- 4 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
McKinsey JF, Zeller T, Rocha-Singh KJ, Jaff MR, Garcia LA; DEFINITIVE LE Investigators. Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE study. JACC Cardiovasc Interv. 2014 Aug;7(8):923-33. doi: 10.1016/j.jcin.2014.05.006.
PubMed 25147039
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Effectiveness of SilverHawk Peripheral Plaque Excision (SilverHawk Device) for the Treatment of Infrainguinal Vessels/Lower Extremities
- ClinicalTrials.gov ID
- NCT00883246
- Acronym / sponsor ID
- DEFINITIVE LE
- Keywords
- PAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Apr 2009 (estimated)
- Results
- Posted 9 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atherectomy | Other | Device: SilverHawk & TurboHawk Peripheral Plaque Excision SystemAll patients enrolled in this single-arm study were treated with directional atherectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has a Rutherford Clinical Category Score of 1 - 6.
- Has evidence of ≥ 50% stenosis or occlusion in the superficial femoral, popliteal, anterior tibial, posterior tibial and/or peroneal arteries, confirmed by angiography.
- Has identifiable distal target vessel which upon completion of the intervention, is anticipated to provide re-constitution of blood flow to the foot.
- Exchangeable guidewire must cross lesion(s), with ability of catheter to cross lesion.
- Each discrete target lesion's length is ≤ 20 cm.
Key exclusion criteria (11 listed)
- Has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure.
- Has any planned surgical intervention or endovascular procedure within 30 days after the index procedure.
- Has had a previous peripheral bypass affecting the target limb.
- Has end-stage renal disease defined as undergoing hemodialysis for kidney failure.
- Has presence of severe calcification in target lesion(s).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SilverHawk & TurboHawk Peripheral Plaque Excision SystemAlso: SilverHawk (Atherectomy), TurboHawk (Atherectomy)Removal of atherosclerotic plaque from artery walls. | Device | Atherectomy |
Primary outcome
Primary Patency Rate (in Patients Treated for Claudication RCC 1-3)
Time frame: One year
The primary endpoint analysis for claudication subjects was primary patency rate at one year, defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who had claudication (RCC of 1 - 3) at time of enrollment.
Amputation-Free Survival at 1 Year (in Patients Treated for Critical Limb Ischemia RCC 4-6)
Time frame: One Year
The primary endpoint for CLI was amputation-free survival at one year, defined as freedom from a major, unplanned amputation of the target limb through the 1-year visit in subjects who have CLI (RCC 4 - 6) at time of enrollment.
12 secondary outcomes
Device Success (in All Patients Enrolled)
Time frame: Immediately following use of the SilverHawk device
Procedural Success (in All Patients Enrolled)
Time frame: Immediately following use of the SilverHawk and adjunctive devices
Major Adverse Event Rate (in All Patients Enrolled)
Time frame: 30 Days
Major Adverse Event Rate (in All Patients Enrolled)
Time frame: One Year
Improvement in Walking Impairment Questionnaire Score (in Patients Treated for Claudication RCC 1-3)
Time frame: Baseline and 1 Year
Improvement in Rutherford Clinical Category (in All Patients Enrolled)
Time frame: 1 Year
Ankle-Brachial Index (in All Patients Enrolled)
Time frame: 1 Year
Secondary Patency (in Patients Treated for Claudication RCC 1-3)
Time frame: One Year
Primary Patency (in Patients Treated for Critical Limb Ischemia RCC 4-6)
Time frame: One Year
Amputation-Free Survival (in Patients Treated for Claudication RCC 1-3)
Time frame: One Year
Improvement in Wound Healing (in Patients Treated for Critical Limb Ischemia and With Wounds RCC 5-6)
Time frame: 3 months
Alternative Patency Rate (Peak Systolic Velocity ≤ 2.4) at 1 Year (in Patients Treated for Claudication RCC 1-3)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25147039McKinsey JF, Zeller T, Rocha-Singh KJ, Jaff MR, Garcia LA; DEFINITIVE LE Investigators. Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE study. JACC Cardiovasc Interv. 2014 Aug;7(8):923-33. doi: 10.1016/j.jcin.2014.05.006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Garcia, MD principal investigator
St. Elizabeth's Medical Center, Tuft's University School of Medicine
James McKinsey, MD principal investigator
The New York Presbyterian/Columbia University
Professor Thomas Zeller principal investigator
Herz-Zentrum Bad Krozingen Germany
Questions about this trial
What is this clinical trial studying?
A study testing SilverHawk & TurboHawk Peripheral Plaque Excision System in people with Peripheral Arterial Disease and Claudication, run by Medtronic Endovascular.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency Rate (in Patients Treated for Claudication RCC 1-3) (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00883246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.