Calcified occlusive atherosclerotic lesion in the superficial femoral artery (SFA) and/or popliteal
Conditions
Interventions
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.
Sponsors
Hanada Kozo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 =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
Exclusion criteria
Exclusion 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 =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 Periph
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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] | — |
Contacts
Public ContactKozo Hanada
Abbott Medical Japan LLC
Outcome results
None listed