Exploratory Trial of JFK-01 (Coronary Artery Absorbable Magnesium Alloy Scaffold)

JRCT ID: jRCT2052220154

Registered date:22/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: ischemic heart disease
• Date of first enrollment: 12/01/2023
• Target sample size: 30
• Study type: Other

Outcome(s)

Primary Outcome

Procedural success
Angiographic evaluation
OCT and IVUS evaluation

Key inclusion & exclusion criteria

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

Include criteria

1. De Novo Coronary Lesions
2. One lesion or two lesions in one or two branches that are eligible for PCI
3. Lesions with visual diameter stenosis (AHA stenosis classification) greater than 75% and less than 100%.
4. Lesions with TIMI classification grade 1 or higher blood flow
5. Lesions with a visual control vessel diameter of 3 mm and lesion length of 18 mm or less

Exclude criteria

1. highly calcified lesions for which angioplasty by balloon dilation (POBA, cutting balloon, or scoring balloon) appears to be infeasible
2. any of the following lesions or lesions for which adequate delivery of the device under study is not feasible
(1) Severe bending of the target lesion or near site of the target lesion
(2) severe tortuosity of the target lesion or near site of the target lesion (more than 2 bends of 45 degrees or more exist)
3. left main stem artery lesion
4. Bifurcation lesion in which the side branch is jailed by struts due to the implantation of the device in one of the following cases
(1)lesions containing a side branch with a vessel diameter of 2 mm or greater
(2) lesions requiring pre-dilation of the side branch (including kissing balloon)
(3) lesions requiring a protective guidewire
5. lesion within 3 mm from the entrance of the right coronary artery
6. lesion within 3 mm of the origin of the left anterior descending branch of the coronary artery or the left circumflex branch of the coronary artery
7. bypass graft lesions or lesions distal to the bypass graft anastomosis
8. lesions with thrombus in the target vessel on pre-procedure angiography, IVUS, or OCT

Related Information

• Primary Sponsor: Nakazawa Gaku