Confirmatory Study of KCB01 in PCI-eligible patients with coronary stenotic lesions that are difficult to expand with conventional POBA

JRCT ID: jRCT2032220438

Registered date:04/11/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Coronary Heart Disease
• Date of first enrollment: 10/11/2022
• Target sample size: 70
• Study type: Interventional
• Intervention(s): Expand KCB01 (Balloon expandable angioplasty catheters for coronary vessels) to the appropriate pressure for the lesion site.

Outcome(s)

• Primary Outcome: Success rate of manual techniques

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Japanese patients aged 20 years or older
(2) Patients with lesions that physicians consider difficult to dilate with conventional POBA and are eligible for PCI
(3) Patients with a confirmed diagnosis of class II or higher by CCS classification
(4) Patients with target lesion diameter between 2.0 mm and 4.0 mm (visual evaluation)
(5) Target lesion length is 38 mm or less (visual evaluation)
(6) Patients with target lesion diameter stenosis greater than 75% (visual evaluation)
(7) Patients with a 0.014-inch guidewire passing through the target lesion
(8) Patients in whom indentation of the target lesion could not be obtained by dilating the target lesion at the nominal pressure of a normal POBA (visual evaluation)
(9) Patients who have been fully informed about the investigational device and the purpose and details of the study, who voluntarily volunteer to participate in the study, and whose written consent to participate in the study has been obtained.

Exclude criteria

(1) Patients with cardiogenic shock
(2) Patients after cardiopulmonary resuscitation
(3) Patients with a left ventricular ejection fraction (LVEF) of less than 40% within 30 days prior to the investigational procedure
(4) Patients with New York Heart Association (NYHA) Class III or IV heart failure
(5) Patients who have undergone PCI within 30 days prior to the study procedure or are scheduled to undergo PCI within 30 days after the study procedure
(6) Patients with evidence of acute myocardial infarction (STEMI or non-STEMI) within 30 days prior to the study procedure (CK value more than twice the institutional reference value or CK-MB elevation above the upper limit of the institutional reference value)
(7) Patients who have experienced a stroke or transient ischemic attack (TIA) within 6 months prior to the investigational procedure
(8) Patients who are not eligible for emergency CABG
(9) Patients with known contraindications or hypersensitivity reactions to aspirin, heparin, clopidogrel, ticlopidine, prasugrel, and ticagrelor
(10) Patients with a platelet count less than 100000
(11) Patients with a history or complication of peptic ulcer or gastrointestinal bleeding within 6 months prior to the investigational procedure
(12) Patients with diabetes mellitus and poor drug control
(13) Patients who are allergic to contrast media and cannot adequately respond to premedication
(14) Pregnant or lactating patients at the time of obtaining consent
(15) Patients with a medical condition with a life expectancy of less than 12 months
(16) Patients participating in other clinical trials at the time of consent
(17) Patients with unprotected left main coronary artery lesions (stenosis upper 50%) (visual evaluation)
(18) Patients whose target lesion is in a vessel that can only be reached through the saphenous vein or arterial bypass graft (including within an arterial bypass graft)
(19) Patients whose target lesion is located in or distal to a vessel with a bend of greater than 45 degrees in the target lesion (visual evaluation)
(20) Patients with excessive tortuosity (defined as the presence of two or more bends greater than 90 degrees or three or more bends greater than 75 degrees) in the target vessel (visual evaluation)
(21) Patients with thrombus or ulceration (by angiography or intravascular imaging) in the target vessel
(22) Patients with angiographic evidence of severe dissection (defined as type D or greater dissection in the NHLBI classification) in the target vessel after POBA dilation
(23) Patients whom the investigator or subinvestigator determines to be inappropriate to participate in the clinical trial

Related Information

• Primary Sponsor: Nakamura Masato