Clinical trial NCT03495453: Directional Versus Orbital Atherectomy Plaque Modification and Luminal Area Assessment of the Femoro-popliteal Artery Via Intravascular Ultrasound
Official title: Directional Versus Orbital Atherectomy Plaque Modification and Luminal Area Assessment of the Femoro-popliteal Artery Via Intravascular Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Change in Minimal Luminal Area
timeFrame: Day 0, Immediately before procedure, immediately after procedure
measure: Change in Percentage Diameter Stenosis (%DS)
timeFrame: Day 0, Immediately before and after procedure
Secondary outcomes:
measure: Change in Percentage Plaque Volume
timeFrame: Day 0, Immediately before procedure, immediately after procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Anvar Babaev, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: