This is a prospective, single-arm, multi-center study designed to evaluate the safety and efficacy of the Orbital Atherectomy System (OAS) for the treatment of adult Japanese subjects with a de novo symptomatic calcified occlusive atherosclerotic lesion in the superficial femoral artery (SFA) and/or popliteal (POP) artery, which would be otherwise ineligible for endovascular therapy due to risk of complication. Study objective is to collect safety and effectiveness data to support potential commercialization of the peripheral OAS device in Japan.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Treatment with Orbital Atherectomy System (OAS) followed by Percutaneous Old Balloon Angioplasty (POBA), pre-dilation and Drug Coated Balloon (DCB) - Medtronic IN.PACT™ Admiral™
Tokyo bay Ichikawa
Urayasu, Chiba, Japan
Matsuyama Red Cross
Matsuyama, Ehime, Japan
Fukuoka Sannou
Sawara, Fukuoka, Japan
Iwaki-City Medical Center
Percentage of Subjects With Acute Device Success
The percentage of subjects with the following, post-procedure: 1. ≤50% residual stenosis post OAD + POBA \[Angiographic Core Lab assessed\] and, 2. No OAS-related severe angiographic complications defined as severe dissections (D-F), perforation, or distal emboli requiring additional treatment during the procedure \[CEC adjudicated\].
Time frame: At the end of the procedure
Change in Lesion Stenosis
The percentage changes in diameter stenosis of the target lesion at each stage of the procedure: Baseline, Post OAD, Post POBA and Post DCB \[Angiographic Core Lab assessed\].
Time frame: Baseline, Post OAD, Post POBA
Acute Technical Success
Acute technical success defined per the Peripheral Academic Research Consortium (PARC) definition of achievement of a final residual stenosis \<30% for stented and \<50% for non-stented subjects by angiography at the end of the procedure \[Angiographic Core Lab assessed\] without severe angiographic complications defined as severe dissections (D-F), perforation, or distal emboli requiring additional treatment during the procedure \[CEC adjudicated\].
Time frame: At the end of the procedure
Drug Coated Balloon (DCB) Device Success
DCB Device Success defined as the ability to achieve successful delivery and deployment of all DCB to the target lesion as described per the Instructions for Use (IFU) within 3 minutes of insertion without removal and use of an additional device.
Time frame: Within 3 minutes of insertion of DCB
Target Vessel Patency
Target Vessel Patency is a binary composite endpoint comprised of: * CEC adjudicated absence of clinically driven repeat procedure performed for ≥50% stenosis confirmed by angiography within all or part of the target lesion after documentation of recurrent clinical symptoms of PAD following clinical trial treatment procedure (i.e. clinically-driven TLR) occurring at any time-point on, or prior to the 6-month visit date and, * a Duplex Ultrasound Core Lab assessed PSVR value of ≤2.4 (or equivalent by visual assessment if the lesion is non-patent and the PSVR cannot be numerically calculated). The vessel is considered patent if both criteria are met at the time of assessment.
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Iwaki, Fukushima, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan
Kyoto Katsura Hospital
Nishikyo-ku, Kyoto, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Nara Medical University
Kashihara, Nara, Japan
Morinomiya
Joto, Osaka, Japan
Ageo Central Hospital
Ageo, Saitama, Japan
...and 2 more locations
Time frame: Up to 6 months
Rate of Severe Angiographic Complications
Rate of severe angiographic complications defined as severe dissections (D-F), perforation, or distal emboli requiring additional treatment during the procedure \[CEC adjudicated\]
Time frame: At the end of the procedure
Acute Procedural Success
Acute procedural success is defined as both acute technical success and absence of death, stroke, myocardial infarction (MI), acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and/or need for urgent/emergent vascular surgery within 72 hours of the clinical trial treatment \[CEC adjudicated\].
Time frame: 72 hours after index procedure
Rate of Major Adverse Event (MAE)
Major Adverse Event (MAE) rate at 30 days and 6 months (CEC adjudicated) was defined as: 1. All-cause death through 30 days or 2. Major amputation of the target limb or 3. Clinically-driven TLR
Time frame: 30 days and 6 months
Change of Rutherford Classification (ITT Population)
Rutherford Classification; Class 0: Asymptomatic; no hemodynamically significant occlusive disease. Class 1: Mild Claudication; there is no limitation with ordinary physical activities (e.g., walking several blocks, climbing stairs). Limiting symptoms may occur with marked exertion (e.g., strenuous, rapid or prolonged exertion at work or recreation). Class 2: Moderate Claudication; there is a slight limitation of ordinary physical activities (e.g., walking uphill, or more than two level blocks, or climbing stairs rapidly). Subject is comfortable at rest. Class 3: Severe Claudication; there is marked limitation of ordinary physical activities (e.g., walking 1-2 level blocks or climbing one flight of stairs). Subject is comfortable at rest. Class 4: Ischemic rest pain. Class 5: Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia. Class 6: Major tissue loss extending above transmetatarsal level; functional foot no longer salvageable.
Time frame: Baseline, 30 days and 6 months
Change of Rutherford Classification (mITT Population)
Rutherford Classification; Class 0: Asymptomatic; no hemodynamically significant occlusive disease. Class 1: Mild Claudication; there is no limitation with ordinary physical activities (e.g., walking several blocks, climbing stairs). Limiting symptoms may occur with marked exertion (e.g., strenuous, rapid or prolonged exertion at work or recreation). Class 2: Moderate Claudication; there is a slight limitation of ordinary physical activities (e.g., walking uphill, or more than two level blocks, or climbing stairs rapidly). Subject is comfortable at rest. Class 3: Severe Claudication; there is marked limitation of ordinary physical activities (e.g., walking 1-2 level blocks or climbing one flight of stairs). Subject is comfortable at rest. Class 4: Ischemic rest pain. Class 5: Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia. Class 6: Major tissue loss extending above transmetatarsal level; functional foot no longer salvageable.
Time frame: Baseline, 30 days and 6 months
Change in Ankle Brachial Index (ABI)
The Ankle-Brachial Index (ABI) is a simple, non-invasive test used to assess peripheral artery disease (PAD). It compares the blood pressure measured at the ankle with the blood pressure measured at the arm (brachial artery).
Time frame: Baseline (within 30 days of the clinical treatment), and Post Procedure (after the clinical trial treatment prior to discharge: post procedure ABI was collected on average 1.1 days post clinical trial treatment)