CASTLE Study

Phase 4

• Conditions: Coronary artery disease requiring PCI treatment

• Registration Number: JPRN-jRCTs032180084
• Lead Sponsor: akamura Masato

Brief Summary

This study demonstrated that BP-SES is non-inferior to DP-EES in the imaging guided implantation of DES. The previous study showed the superiority of BP-SES. It was considered that the difference in the incidence of myocardial infarction in the target vessel contributed to the result, but the incidence in this study was the same between two groups. (BP-SES 31/722 (4.3%), DP-EES 28/718 (3.9%) p = 0.706)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-17
• Study Completion: 2021-04-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1515

Inclusion Criteria

1. Symptomatic coronary artery disease
2. Subject is acceptable for angiography and willing to comply with all study followup requirements.
3. Subject is 20 years old or older.
4. Subject who requires PCI medically

Exclusion Criteria

1. Subject is unable to provide written informed consent.
2. Contraindication to antithrombotic therapy and/or anticoagulant therapy.
3. Difficulty in adequate pharmacotherapy.
4. Contraindication and/or allergy to contrast medium.
5. Planned cardiac surgery.
6. Subject is participating in another study and the observation period has not completed.
7. In the investigator's or sub-investigator's opinion, subject is deemed inappropriate for participating to study .

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target lesion failure (TLF) post stent replacement

Secondary Outcome Measures

Name	Time	Method
[Efficacy]<br>Device success<br>Lesion success (residual stenosis < 30%)<br>Procedure success<br>[Safety]<br>Myocardial infarction<br>Myocardial infarction and cardiac death<br>Major adverse cardiac events (MACE) and major adverse cardiac and cerebrovascular events (MACCE)<br>Individual TLF components<br>Target vessel failure (TVF) and individual TVF components<br>Stent thrombosis based on ARC definition<br>Bleeding events (Bleeding category based on BARC Classification, Major bleeding and Minor bleeding with reference to TIMI Classification)