Directional Versus Orbital Atherectomy Plaque Modification and Luminal Area Assessment of the Femoro-popliteal Artery Via Intravascular Ultrasound

December 6, 2023 updated by: NYU Langone Health
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 Overview

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy (OAS)
OAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB)
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.
Active Comparator: Medtronic's Hawkone Directional Atherectomy system (DAS)
DAS (using the Hawkone device) followed by DCB
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0, Immediately before procedure, immediately after procedure
Change in Percentage Diameter Stenosis (%DS)
Time Frame: Day 0, Immediately before and after procedure
Angiographic measurements of diameter stenosis following atherectomy
Day 0, Immediately before and after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Percentage Plaque Volume
Time Frame: Day 0, Immediately before procedure, immediately after procedure
To be measured and analyzed via Intravascular Ultrasound (IVUS)
Day 0, Immediately before procedure, immediately after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anvar Babaev, MD, PhD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2018

Primary Completion (Actual)

August 21, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

March 26, 2018

First Submitted That Met QC Criteria

April 4, 2018

First Posted (Actual)

April 12, 2018

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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