Kaitoh Atherectomy FIH

Launched by TERUMO MEDICAL CORPORATION · May 23, 2023

Keywords

ClinConnect Summary

The Kaitoh Atherectomy FIH clinical trial is studying a new treatment called the Kaitoh Atherectomy System for people with Peripheral Arterial Disease, which affects blood flow in the legs. This trial aims to determine how safe and effective this device is for treating certain blockages in the peripheral arteries. It is currently recruiting participants aged 18 and older, but most participants will be between 65 and 74 years old. To join, individuals must have specific symptoms (classified as Rutherford Classification 3-5) and be willing to follow up with the study team at 30 and 180 days after the procedure.

Participants in this study can expect to undergo a procedure using this new device while receiving regular check-ups to monitor their progress. However, some people may not be eligible, such as those who are pregnant, have a serious illness, or have had recent surgery on the affected area. This study is important because it could lead to new options for treating blockages in the arteries, helping improve blood flow and overall health for those affected by this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years old
• • Rutherford Classification: 3-5 in target limb; Rutherford Classification 3 subjects may be enrolled but will be capped to a limit of 20% of the total enrollment (no more than two Rutherford Class 3 subjects may be enrolled into the study).
• • Able and willing to provide informed consent, and comply with follow-up visits at both 30 days and 180 days (6 months)
• • Able to comply with antiplatelet therapy as required
• • Reference Vessel Diameter is ≥2.0 mm and ≤4.0 mm
• • Target lesion length is ≤150 mm
• • De novo or restenotic target lesion(s) (except for in-stent restenotic lesion) with stenosis ≥70%, by visual estimation, in a single limb in a single native vessel
• • Inflow artery is patent, free from significant lesion stenosis (≥50% stenosis is considered significant) as visually confirmed by angiography. Note: Successful inflow artery treatment is allowed during the index procedure. Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤50% without major vascular complications (absence of flow limiting dissection, embolic event)
• • Guidewire has successfully crossed the target lesion(s) within the true lumen
• Exclusion Criteria:
• • Females who are pregnant or lactating
• • Pre-existing illness with life expectancy \<1 year
• • Known or suspected systemic infection
• • Significant gastrointestinal bleeding or any coagulopathy that would preclude the use of anti-platelet therapy
• • Subjects with a diagnosis of osteomyelitis and are currently on IV antibiotic therapy
• • Endovascular or surgical procedure performed on the target lesion within 3 months of the index procedure
• • Subjects who in the opinion of the Investigator have underlying kidney disease and may be at risk for contrast-induced acute kidney injury (AKI)
• • Subjects who in the opinion of the Investigator have uncontrolled diabetes
• • Allergic to iodine/radiopaque contrast that in the opinion of the Investigator cannot be adequately pre-treated
• • History of Coronary Artery Bypass Graft (CABG), unstable angina pectoris, or myocardial infarction within 30 days and/or hemorrhagic stroke within 90 days
• • Subjects scheduled to undergo a planned major amputation of the lower limb above the ankle on the target limb
• • Allergic to any of the components of the atherectomy device system
• • Intraprocedural complications prior to use of the investigational device
• • Subjects with a positive COVID-19 test within the last 60 days and/or is symptomatic, at the Investigator's discretion
• • Subject with other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre - and post-treatment
• • Presence of flow-limiting stenosis (\>50% diameter reduction) or occlusion of inflow vessels that was not successfully treated (\<50% residual stenosis without flow limiting dissection) before the study intervention/prior to the point of enrollment
• • No obvious angiographic evidence of flow to the foot following inflow treatment
• • Co-existing aneurysmal disease requiring treatment
• • Presence of vessel dissection at the target lesion requiring stent placement
• • Clinical/angiographic evidence of distal embolization or acute thrombus
• • Severe calcification that is measured \>10mm in length and circumferential
• • Prior stent placement in the target lesion