An "All-Comers" Study of the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter Used in Real-World Clinical Practice in Chinese Patients

Chinese Patients Treated With Agent DCB Clinical Trial

Official title:

Agent DCB Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04085445
• Other study ID #: S2460
• Status: Active, not recruiting
• Start date: November 13, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To compile the real-world clinical outcome data for the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter (Agent DCB) used in percutaneous coronary intervention (PCI) in Chinese patients.

Description:

The Agent DCB Registry study will enroll 500 subjects at up to 10 investigational sites in Taiwan, Hong-Kong and Singapore.

If participants decide to participate in this study, participants will first be asked to sign and date this consent form. If participants sign the consent form, participants will go through a baseline/ procedure process. Information about participants and participants' health will be collected and participants will have a limited physical examination.

Participants will need to have the laboratory tests (including myocardial enzyme test before and post the index procedure, pregnancy test before the index procedure) and other assessments to find out if participants meet the requirements to be in the study and to ensure it is safe for participants to have the procedure. These tests and assessments are part of routine care and may be done even if participants do not join the study. If participants have had some of them recently, they may not need to be repeated.

Participants will be expected to follow the scheduled follow-ups which occur at 30 days, 6 and 12 months, and then annually through 3 years post the index procedure for all enrolled subjects. Angiographic follow-up will perform at 9 months post index procedure for all the subjects with small vessel lesions and the first 100 consecutively enrolled subjects with ISR lesions. Enrolled subjects with the failure of advancing Agent DCB across target lesion will be followed through hospital discharge following the initial attempted index procedure.

Participants' participation in the study will be completed after approximately 3 years.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chinese subject at least 18 years of age(or meet age requirements per local law).

• Subject (or legal guardian) who understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.

• Subject who has ischemic symptoms or evidence of myocardial ischemia and is clinically indicated for PCI and will be treated with Agent DCB.

• Subject is willing to comply with all protocol-required follow-up evaluation.

• In women with childbearing potential a negative pregnancy test is mandatory.

• Subject with no known intolerance to paclitaxel and no contraindications to antiplatelet regimen.

Exclusion Criteria:

• Exclusion criteria are not required in the Agent DCB registry study as it is an "all comers" study.

Related Conditions & MeSH terms

• Chinese Patients Treated With Agent DCB

Intervention

Device:
• AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter
To compile the real-world clinical outcome data for the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter (Agent DCB) used in percutaneous coronary intervention (PCI) in Chinese patients.

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong
Singapore	Tan Tock Seng Hospital	Singapore
Taiwan	Hualien Tzu Chi Hospital	Hualien City
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Cheng Hsin General Hospital	Taipei
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Hong Kong,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with 12 months post index procedure	Major adverse cardiac event (MACE) rate, defined as cardiac death, myocardial infarction (MI, Q-wave and non-Q-wave) and target vessel revascularization (TVR),Target lesion revascularization (TLR) and target lesion failure (TLF) rates	12 months