Peripheral Artery DiseaseNCT03495453
Directional Versus Orbital Atherectomy Plaque Modification and Luminal Area Assessment of the Femoro-popliteal Artery Via Intravascular Ultrasound
A study testing Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS and Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device in people with Peripheral Artery Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
This single center prospective, randomized study will be conducted to investigate plaque removal and luminal gain using CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy System (OAS) (St.Paul, MN) versus Medtronic's Hawkone Directional Atherectomy system (DAS) (Minneapolis, MN) assessed by angiography and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS and Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2018to 31 Aug 2023
- 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
- Subject's age ≥ 18 years;
- Subject (or Legal Guardian if applicable) is willing and able to provide consent before any study-specific test or procedure is performed, signs the consent form, and agrees to attend all required follow-up visits.
- Chronic, symptomatic lower limb ischemia defined as Rutherford categories 1-4
- Target lesion(s) located in a superficial femoral or popliteal arteries
- Degree of stenosis ≥70% via Qualitative Comparative Analysis (QCA)
- Total Lesion Length ≥ 80 mm and ≤ 150 mm
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- Reference Vessel ≥ 3.0 mm and <6.5mm
- Patent infrapopliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot with no planned intervention.
- Subject is an acceptable candidate for percutaneous intervention using the OAS or DAS in accordance with their labeled indications and instructions for use
Who cannot join
- Subjects who have an:
- Previously stented target lesion/vessel.
- Subjects who have undergone prior surgery of the SFA/PA in the target limb to treat atherosclerotic disease.
- Presence of aneurysm in the target vessel.
- Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
- Target vessel with moderate or severe angulation (e.g., > 30°) or tortuosity at the treatment segment, that precludes safe advancement of the atherectomy device.
Show all 16Show fewer
- Pre-planned interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than OAS or DAS.
- Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated.
- Known hypersensitivity/allergy to antiplatelet, anticoagulant, thrombolytic medications
- Platelet count <80,000 mm3 or >600,000 mm3 or history of bleeding diathesis.
- Patient has any known coagulation disorder, including hypercoagulability
- Receiving dialysis or immunosuppressant therapy.
- Patient has evidence of intracranial or gastrointestinal bleeding within last 3 months.
- Patient has history of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within past 14 days,
- Female patient who is pregnant or nursing a child,
- Current participation in another investigational drug or device clinical study that has not completed the primary endpoint at the time of randomization/enrollment or that clinically interferes with the current study endpoints.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
This single center prospective, randomized study will be conducted to investigate plaque removal and luminal gain using CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy System (OAS) (St.Paul, MN) versus Medtronic's Hawkone Directional Atherectomy system (DAS) (Minneapolis, MN) assessed by angiography and Intravascular Ultrasound (IVUS) in patients diagnosed with symptomatic obstructive femoro-popliteal disease will be analyzed. Both devices have received clearance by the Food and Drug Administration (FDA) for use by the label indication.Subjects will be randomized in a 1:1 fashion to receive treatment with either OAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB) or DAS (using the Hawkone device) followed by DCB. Subjects in both arms will undergo IVUS before and after atherectomy, as well as at the conclusion of the procedure. Clinical data will be collected at baseline, immediately prior to the procedure, during and immediately after the procedures, and within 30 days, 6 and 12 months office visits after the procedure. Data may also be collected at office or hospital visits that are not scheduled but occur up to 12 months after the procedure, if they pertain to treatment related to the obstructive SFA disease. Data to be collected for this study includes demographics, medical history, procedural parameters and follow-up. The study will be conducted at one study center, 90 subjects will be enrolled in the trial with plan to accrue 60 subjects - 30 patients enrolled in the OAS arm and 30 patients enrolled in the DAS arm. The duration of the study is expected to be approximately 2 years from the date of first enrollment (1 year for enrollment of 60 subjects and a year for follow-up).
- Conditions
- Peripheral Artery Disease
- Being tested
- Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS, Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Revascularization of the Femoropopliteal Arteries using a DASDevice
Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is a small catheter with a diamond crown. The doctor inserts it at the groin and advances into the leg.The OAS works by spinning around inside the artery to "sand down" the buildup of material along the artery walls while leaving the healthy vessel behind.
Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS deviceDevice
HawkOne Directional Atherectomy System (DAS) also is the small catheter with cutting device. Doctor slowly and smoothly advances it across the blockage in your artery and shaves the plaque from the vessel wall and collects it in the reservoir.
| Study group | Role | What they receive |
|---|---|---|
| CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy (OAS) | Active comparator | OAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB) Receives: Device: Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device |
| Medtronic's Hawkone Directional Atherectomy system (DAS) | Active comparator | DAS (using the Hawkone device) followed by DCB Receives: Device: Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Minimal Luminal Area
To be measured via Intravasular Ultrasound (IVUS) before and after atherectomy
Measured: Day 0, Immediately before procedure, immediately after procedure
Change in Percentage Diameter Stenosis (%DS)
Angiographic measurements of diameter stenosis following atherectomy
Measured: Day 0, Immediately before and after procedure
Secondary outcomes (1)
Change in Percentage Plaque Volume
To be measured and analyzed via Intravascular Ultrasound (IVUS)
Measured: Day 0, Immediately before procedure, immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start23 Mar 2018
- Primary completion21 Aug 2023
- Study completion31 Aug 2023
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.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anvar Babaev, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495453
- Sponsor's protocol ID
- 18-00005
- Status last verified
- Dec 2023
- First submitted
- 26 Mar 2018
- Last updated
- 26 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Directional Versus Orbital Atherectomy Plaque Modification and Luminal Area Assessment of the Femoro-popliteal Artery Via Intravascular Ultrasound
- ClinicalTrials.gov ID
- NCT03495453
- Acronym / sponsor ID
- 18-00005
- Conditions
- Peripheral Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Posted 19 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single center prospective, randomized study will be conducted to investigate plaque removal and luminal gain using CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy System (OAS) (St.Paul, MN) versus Medtronic's Hawkone Directional Atherectomy system (DAS) (Minneapolis, MN) assessed by angiography and Intravascular Ultrasound (IVUS) in patients diagnosed with symptomatic obstructive femoro-popliteal disease will be analyzed. Both devices have received clearance by the Food and Drug Administration (FDA) for use by the label indication.Subjects will be randomized in a 1:1 fashion to receive treatment with either OAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB) or DAS (using the Hawkone device) followed by DCB. Subjects in both arms will undergo IVUS before and after atherectomy, as well as at the conclusion of the procedure. Clinical data will be collected at baseline, immediately prior to the procedure, during and immediately after the procedures, and within 30 days, 6 and 12 months office visits after the procedure. Data may also be collected at office or hospital visits that are not scheduled but occur up to 12 months after the procedure, if they pertain to treatment related to the obstructive SFA disease. Data to be collected for this study includes demographics, medical history, procedural parameters and follow-up. The study will be conducted at one study center, 90 subjects will be enrolled in the trial with plan to accrue 60 subjects - 30 patients enrolled in the OAS arm and 30 patients enrolled in the DAS arm. The duration of the study is expected to be approximately 2 years from the date of first enrollment (1 year for enrollment of 60 subjects and a year for follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy (OAS) | Active comparator | Device: Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS deviceOAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB) |
| Medtronic's Hawkone Directional Atherectomy system (DAS) | Active comparator | Device: Percutaneous Revascularization of the Femoropopliteal Arteries using a DASDAS (using the Hawkone device) followed by DCB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject's age ≥ 18 years;
- Subject (or Legal Guardian if applicable) is willing and able to provide consent before any study-specific test or procedure is performed, signs the consent form, and agrees to attend all required follow-up visits.
- Chronic, symptomatic lower limb ischemia defined as Rutherford categories 1-4
- Target lesion(s) located in a superficial femoral or popliteal arteries
- Degree of stenosis ≥70% via Qualitative Comparative Analysis (QCA)
Key exclusion criteria (16 listed)
- Subjects who have an:
- Previously stented target lesion/vessel.
- Subjects who have undergone prior surgery of the SFA/PA in the target limb to treat atherosclerotic disease.
- Presence of aneurysm in the target vessel.
- Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
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 |
|---|---|---|
| Percutaneous Revascularization of the Femoropopliteal Arteries using a DASDiamondback 360 Peripheral Orbital Atherectomy System (OAS) is a small catheter with a diamond crown. The doctor inserts it at the groin and advances into the leg.The OAS works by spinning around inside the artery to "sand down" the buildup of material along the artery walls while leaving the healthy vessel behind. | Device | Medtronic's Hawkone Directional Atherectomy system (DAS) |
| Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS deviceHawkOne Directional Atherectomy System (DAS) also is the small catheter with cutting device. Doctor slowly and smoothly advances it across the blockage in your artery and shaves the plaque from the vessel wall and collects it in the reservoir. | Device | CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy (OAS) |
Primary outcome
Change in Minimal Luminal Area
Time frame: Day 0, Immediately before procedure, immediately after procedure
To be measured via Intravasular Ultrasound (IVUS) before and after atherectomy
Change in Percentage Diameter Stenosis (%DS)
Time frame: Day 0, Immediately before and after procedure
Angiographic measurements of diameter stenosis following atherectomy
1 secondary outcome
Change in Percentage Plaque Volume
Time frame: Day 0, Immediately before procedure, immediately after procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Anvar Babaev, MD, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS and Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device in people with Peripheral Artery Disease, run by NYU Langone Health at 1 site in United States.
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 9 inclusion and 16 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 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 19 Aug 2022). 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?
Change in Minimal Luminal Area (time frame: Day 0, Immediately before procedure, immediately after procedure). 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?
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 26 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.