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

Phase 4

Recruiting

Conditions: Ichemic heart disease with PCI indication
Ischemic heart disease
D017202

Registration Number: JPRN-jRCTs032230543

Lead Sponsor: Kozuma Ken

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 200

Inclusion 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

Exclusion 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

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