Lesion preparation comparison for drug-coated balloon angioplasty: the NATURE study

JRCT ID: jRCTs032230543

Registered date:05/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ichemic heart disease with PCI indication
• Date of first enrollment: 05/01/2024
• Target sample size: 200
• Study type: Interventional

Intervention(s)

1. Randomly assign to either "cutting balloon" or "normal balloon" for lesion preparation procedure
2. Use AgentTM(Paclitaxel Coated-PTCA Balloon Catheter ) for the DCB target de novo lesion of 2.5-4.0mm diameter

Outcome(s)

• Primary Outcome: Achievement rate of DCB use criteria (based on the international DCB consensus group) determined by 1) angiographic results evaluated at core lab and 2) FFR measured during PCI

Secondary Outcome

1. Clinically assessed success rate of DCB use
2. Number, ratio, and survival curve of clinical events
3. Number and ratio of composite events compared between each of the randomized groups
4. Number and ratio of late lumen enlargement 9 months after the index PCI in the patients treated with DCB
5. IVUS findings correlated with 12-month composite endpoints and 9-month late lumen enlargement
6. Correlation between QFR and FFR after the pre-dilatation
7. Number and percentage of AE events in the >3.0mm lesion treated with DCB

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Disease Criteria (either one of followings):
a. Chronic coronary syndrome with at least 90% angiographic stenosis or proven ischemia with
PCI indication
b. Unstable angina without troponin elevation
2. PCI target lesion is appropriate for DCB angioplasty (de novo lesion of 2.5-4.0mm diameter and
no longer than 28mm)
3. Age greater than or equal to 18 years old
4. Signed informed consent form
5. One year availability for follow up hospital visit or calls from the index PCI

Exclude criteria

1. Acute myocardial infarction (including NSTEMI) or subacute myocardial infarction
2. Unstable vital signs
3. Advanced coronary artery diseases inappropriate for PCI treatment (equivalent to SYNTAX score >=33)
4. Renal dysfunction with eGFR below 30ml/min or currently on hemodialysis
5. Expecting periprocedural withdrawal of antiplatelets within 3months after the index PCI
6. Planned additional PCI on the index PCI target vessel
7. Allergic to any PCI related medications, agents, or metals, and no available accepted mitigating measures
8. Current or anticipated pregnancy, or currently breast feeding
9. Currently or likely to be participated in other clinical trials within 12 months after the index PCI
10. Considered by the investigator or any sub-investigator as inappropriate for this study

Related Information

• Primary Sponsor: Kozuma Ken
• Source(s) of Monetary Support: Boston Scientific Japan K.K.