KAIZEN: Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy

JRCT ID: jRCT2072220030

Registered date:25/07/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Calcified occlusive atherosclerotic lesion in the superficial femoral artery (SFA) and/or popliteal
• Date of first enrollment: 10/01/2023
• Target sample size: 100
• Study type: Interventional

Intervention(s)

After confirming eligibility for the Clinical Trial Treatment by angiography/IVUS, the procedure is as follows:
1. OAS Guide Wire must be delivered via a femoral artery and crosses the Target Lesion.
2. If the OAS Guide Wire crosses the Target Lesion without complication, the OAD can be inserted and proceed with Clinical Trial Treatment.
3. After treatment with OAD, pre-dilatation treatment with POBA, followed by DCB deployment.

Outcome(s)

Primary Outcome

Acute Device Success defined post-procedure as the percentage of subjects with:
a) =<50% residual stenosis post Orbital Atherectomy Device (OAD) + Plain Old Balloon Angioplasty (POBA) [Angiographic Core Lab assessed] and,
b) No OAS-related severe dissections (D-F), perforation, or distal emboli requiring additional treatment during the procedure [CEC adjudicated]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

General Inclusion Criteria
- Subject is 18 years of age or older
- Subject has signed the approved KAIZEN study Informed Consent Form (ICF) prior to any study-related procedures
- Subject has chronic, symptomatic lower limb ischemia defined as Rutherford classification (RC) 2-4
- Subject has a clinical indication for percutaneous transluminal angioplasty (PTA) intervention in the native SFA and/or POP (P1 and/or P2) artery via femoral access

Clinical Trial Treatment Inclusion Criteria
- De novo target lesion in the native SFA and/or POP (P1 and/or P2) artery
- All guidewires cross the Target Lesion within the true lumen without a sub-intimal course
- Target lesion with >=70% stenosis [confirmed by visual estimate via angiography]
- Target reference vessel diameter (RVD) >=3.0 mm and =<6.0 mm [confirmed by visual estimate via angiography]
- Target lesion length =<150 mm [confirmed by visual estimate via angiography]
- Subject has at least one patent tibial vessel (anterior tibial artery, posterior tibial artery, or peroneal artery) on the target leg, defined as having both:
a)Blood flow to the foot, and
b)No stenosis >50%
- Target lesion has visual evidence of calcification based on the KAIZEN calcification definition:
a) IVUS Calcium Assessment: IVUS Calcium Assessment
b) IVUS Calcium Assessment: >=180 to 269 of calcification
Angiographic Calcium Assessment:
i) >= 1/2 of target lesion length calcified OR
ii) > 50mm of calcium
c) IVUS Calcium Assessment: IVUS cannot cross lesion after one attempted pass
Angiographic Calcium Assessment:
i) Bilateral calcification AND >= 1/2 of target lesion length calcified OR
ii) Bilateral calcification AND >50mm of calcium

Exclude criteria

General Exclusion Criteria
- Subject is female who is pregnant and/or breastfeeding
- Subject is currently participating in another investigational clinical study that has not completed the primary endpoint at the time of enrollment or that clinically interferes with the current study endpoints
- Subject is unwilling to follow the Investigators instructions or follow-up requirements
- Subject has had any non-diagnostic peripheral vascular intervention that was unsuccessful or had complications within 30 days before clinical trial treatment, per the following definition:
a) >50% residual stenosis and/or
b) Presence of angiographically assessed dissection (type D-F), perforation, distal embolization, thrombus and/or slow flow/no reflow
- Subject has had or requires any non-diagnostic coronary intervention within 30 days before clinical trial treatment
- Subject requires any planned non-diagnostic vascular (coronary or peripheral) intervention(s) within 30 days after clinical trial treatment
- Subject has any planned procedures or other medical conditions which, in the Investigators opinion, may interfere with the study result and/or subjects optimal participation in the study
- Subject has had a prior major amputation within one year of the clinical trial treatment on either limb
- Subject has a planned major amputation on either limb
- Subject has life expectancy of =<6 months
- Subject has history of coagulopathy or hypercoagulable bleeding disorder
- Subject has history of MI, or stroke/cerebrovascular accident (CVA) within 6-months prior to the clinical trial treatment
- Subject has unstable angina pectoris at the time of the clinical trial treatment
- Subject has untreatable hemorrhagic disease or platelet count <80,000mm^3 or >600,000mm^3 at baseline assessment
- Subject has evidence of active infection on the day of clinical trial treatment requiring oral or intravenous antibiotics
- Subject has known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated or cannot be exposed to the radiation required per the KAIZEN protocol
- Subject has known hypersensitivity/allergy to the investigational atherectomy system or protocol-related therapies (e.g., CSI OAS lubricant, soybean oil, egg yolk phospholipids, glycerin, nitinol, stainless steel, other stent materials, paclitaxel, anticoagulant, or thrombolytic medications)
- Subject has known contraindication to antiplatelet therapy
- Subject has serum creatinine > 2.5 mg/dL, unless on dialysis

Clinical Trial Treatment Exclusion Criteria
- Subject has had any Inflow treatment (ipsilateral iliac and/or common femoral artery) that was unsuccessful or had complications, prior to OAS guidewire insertion, per the following definition:
a) >50% residual stenosis and/or
b) b) Presence of angiographically assessed dissection (type D-F), perforation, distal embolization, thrombus and/or slow flow/no reflow
- Target lesion is a chronic total occlusion (CTO) [confirmed by visual estimate via angiography]
- Subject has presence of any other hemodynamically significant lesions or asymptomatic 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 (P1 and/or P2) artery
- Angiographic evidence of perforation prior to insertion of the CSI Peripheral OAS Guide Wire
- Angiographic evidence of severe (type D-F) dissection prior to insertion of the CSI Peripheral OAS Guide Wire
- Planned use of atherectomy (other than CSI Peripheral OAS), laser, other debulking devices, CTO devices, cutting balloons, scoring balloons, specialty balloons or similar devices in the target limb

Related Information

• Primary Sponsor: Kishimoto Ikuko