Clinical trial NCT05529472: Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy
Official title: KAIZEN: Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: superficial femoral artery
popliteal artery
de novo lesions
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2022-09-07
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: General Inclusion Criteria (≤30 Days from Clinical Trial Treatment):

* 18 years of age or older
* Subject has signed the approved KAIZEN study Informed Consent Form prior to any study-related procedures
* Chronic, symptomatic lower limb ischemia
* Clinical indication for percutaneous transluminal angioplasty intervention in the native SFA and/or POP artery

General Exclusion Criteria (≤30 Days from Clinical Trial Treatment):

* Female who is pregnant and/or breastfeeding
* Currently participating in another investigational clinical study
* Unwilling to follow the Investigator's instructions or follow-up requirements
* Any non-diagnostic peripheral vascular intervention that was unsuccessful or had complications within 30 days before clinical trial treatment
* Any non-diagnostic coronary intervention within 30 days before clinical trial treatment
* Any planned non-diagnostic vascular intervention(s) within 30 days after clinical trial treatment
* Any planned procedures or other medical conditions which, in the Investigator's opinion, may interfere with the study result and/or subject's optimal participation in the study
* Prior major amputation within one year of the clinical trial treatment procedure
* Planned major amputation
* Life expectancy of ≤6 months
* History of coagulopathy or hypercoagulable bleeding disorder
* History of Myocardial Infarction (MI), or stroke/cerebrovascular accident within 6-months prior to the clinical trial treatment
* Unstable angina pectoris
* Untreatable hemorrhagic disease or platelet count \<80,000mm3 or \>600,000mm3
* Evidence of active infection
* Known hypersensitivity or contraindication to contrast dye
* Known hypersensitivity/allergy to the investigational atherectomy system or protocol-related therapies
* Known contraindication to antiplatelet therapy
* Creatinine \> 2.5 mg/dL, unless on dialysis

Clinical Trial Treatment Inclusion:

* De novo target lesion
* All guidewires cross the target lesion within the true lumen
* Target lesion with ≥70% stenosis
* Target reference vessel diameter (RVD) ≥3.0 mm and ≤6.0 mm
* Target lesion length ≤150 mm
* Minimum one patent tibial vessel on the target leg
* Target lesion has visual evidence of calcification

Clinical Trial Treatment Exclusion:

* Any inflow treatment that was unsuccessful or had complications during the clinical trial treatment, prior to subject enrollment
* Target lesion is a chronic total occlusion
* Presence of any other lesions in the target limb requiring a planned surgical intervention or endovascular procedure 30-days after clinical trial treatment
* Presence of aneurysm in the target vessel
* Acute ischemia and/or acute thrombosis of the SFA and/or POP artery
* Angiographic evidence of perforation
* Angiographic evidence of severe dissection
* Planned use of atherectomy other than Cardiovascular Systems, Inc. (CSI) Peripheral OAS in the target limb

Primary outcomes:
measure: Percentage of Subjects with Acute Device Success
timeFrame: Immediate post-procedure
Secondary outcomes:
measure: Target Vessel Patency
timeFrame: 6 months
Other outcomes:
Locations:
city: Urayasu
country: Japan
facility: Tokyo bay Ichikawa
state: Chiba
city: Matsuyama
country: Japan
facility: Matsuyama Red Cross
state: Ehime
city: Sawara
country: Japan
facility: Fukuoka Sannou
state: Fukuoka
city: Iwaki
country: Japan
facility: Iwaki-City Medical Center
state: Fukushima
city: Kamakura-city
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Nishikyo-ku
country: Japan
facility: Kyoto Katsura Hospital
state: Kyoto
city: Sendai
country: Japan
facility: Sendai Kousei Hospital
state: Miyagi
city: Kashihara
country: Japan
facility: Nara Medical University
state: Nara
city: Joto
country: Japan
facility: Morinomiya
state: Osaka
city: Ageo
country: Japan
facility: Ageo Central Hospital
state: Saitama
city: Kasukabe
country: Japan
facility: Kasukabe Central (Chu-o-)
state: Saitama
city: Osaka
country: Japan
facility: Daini Osaka Police Hospital
Study officials:
affiliation: International University of Health and Welfare, Japan
name: Hiroyoshi Yokoi, MD
role: PRINCIPAL_INVESTIGATOR
References: