Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy (KAIZEN)

Abbott

Status

Enrolling

Conditions

Peripheral Artery Disease

Treatments

Device: CSI Peripheral Orbital Atherectomy System (OAS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05529472

CLN-0013-P

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 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 CSI Peripheral OAS in the target limb