KAIZEN: Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 100
- Locations
- 21
- Primary Endpoint
- Percentage of Subjects With Acute Device Success
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of Subjects With Acute Device Success
Time Frame: At the end of the procedure
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 \[CEC adjudicated\].
Secondary Outcomes
- Change in Lesion Stenosis(Baseline, Post OAD, Post POBA)
- Acute Technical Success(At the end of the procedure)
- Drug Coated Balloon (DCB) Device Success(Within 3 minutes of insertion of DCB)
- Target Vessel Patency(Up to 6 months)
- Rate of Severe Angiographic Complications(At the end of the procedure)
- Change in Ankle Brachial Index (ABI)(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))
- Acute Procedural Success(72 hours after index procedure)
- Rate of Major Adverse Event (MAE)(30 days and 6 months)
- Change of Rutherford Classification (ITT Population)(Baseline, 30 days and 6 months)
- Change of Rutherford Classification (mITT Population)(Baseline, 30 days and 6 months)