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

• ClinicalTrials.gov Identifier: NCT03495453
• Recruitment Status: Active, not recruiting
• First Posted: April 12, 2018
• Results First Posted: August 19, 2022
• Last Update Posted: August 19, 2022
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Study Description

Brief 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 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).

Condition or disease	Intervention/treatment	Phase
Peripheral Artery Disease	Device: Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS; Device: Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Directional Versus Orbital Atherectomy Plaque Modification and Luminal Area Assessment of the Femoro-popliteal Artery Via Intravascular Ultrasound
• Actual Study Start Date: March 23, 2018
• Actual Primary Completion Date: August 7, 2020
• Estimated Study Completion Date: December 31, 2023

Arms and Interventions

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)	Device: Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device; 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	Device: Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS; 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.

Outcome Measures

Primary Outcome Measures :

1. 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
2. Change in Percentage Diameter Stenosis (%DS) [ Time Frame: Day 0, Immediately before and after procedure ]
   Angiographic measurements of diameter stenosis following atherectomy

Secondary Outcome Measures :

1. Change in Percentage Plaque Volume [ Time Frame: Day 0, Immediately before procedure, immediately after procedure ]
   To be measured and analyzed via Intravascular Ultrasound (IVUS)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, New York

New York University School of Medicine

New York, New York, United States, 10016

Sponsors and Collaborators

NYU Langone Health

Investigators

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

  Study Documents (Full-Text)

Documents provided by NYU Langone Health:

Study Protocol and Statistical Analysis Plan  [PDF] July 23, 2020

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03495453
• Other Study ID Numbers: 18-00005
• First Posted: April 12, 2018
• Results First Posted: August 19, 2022
• Last Update Posted: August 19, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Additional relevant MeSH terms:

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases