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

Not Applicable

Recruiting

• Conditions: ischemic heart disease

• Registration Number: JPRN-jRCT2052220154
• Lead Sponsor: akazawa Gaku

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Other
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Procedural success<br>Angiographic evaluation<br>OCT and IVUS evaluation