The ALL-RISE Study

JRCT ID: jRCTs052240048

Registered date:30/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic coronary syndromes and non-ST elevation acute coronary syndromes who have a coronary lesion
• Date of first enrollment: 19/06/2024
• Target sample size: 350
• Countries of recruitment: United States,Japan,Israel,Japan,Europe,Japan
• Study type: Interventional
• Intervention(s): Measure the FFR value with the Cathworks FFRangioR or pressure wire guide, and perform PCI or drug therapy.

Outcome(s)

• Primary Outcome: MACE in each group within 1-year after procedure

Secondary Outcome

Efficacy endpoints
1. The following clinical outcomes at 1 year:
a. Individual components of the primary endpoint
b. Definite or probable stent thrombosis
2. Peri-procedural complications at 30 days including:
a. Angiographic complication in the study vessel (e.g. dissection during physiologic assessment or during PCI)
b. Stroke
c. Major bleeding
d. Acute kidney injury (AKI)
3. Patient-reported health status measures (SAQ-7 and EQ-5D-5L)
4. Procedural resource utilization including procedure time, contrast volume, radiation dose, additional drugs and devices utilized, and cost of all healthcare resources associated with the index procedure and index hospitalization
5. Cumulative healthcare-related costs (cost per MACE avoided and cost per quality-adjusted year of life gained)
6. Usability
7. Time to onset of MACE or individual components of MACE
Safety endpoints
1.Presence or absence of any disease occurred
2.Presence or absence of any failure occurred

Key inclusion & exclusion criteria

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

Include criteria

1. Patients presenting with CCS or NSTEACS
2. Patients with eligible lesions (50-90% stenosis) deemed appropriate for physiological assessment of both pressure wire and Cathworks FFRangioR
3. Adult patients (aged 18 years and over)
4.Patients who are able to obtain written informed consent of their own free will of the patient to participate in this clinical studies

Exclude criteria

1. Patients with ST-elevation myocardial infarction (STEMI) within 72 hours prior to enrolment
2. Patients who have previously undergone coronary artery bypass graft surgery (CABG) on the target vessel and are open
3. Patients for whom CABG may be performed based on coronary physiological assessment (but not if PCI is also indicated)
4. Patients whose target vessel perfuses an apparently nonviable myocardial territory, e.g. due to a previous penetrating myocardial infarction
5. Patients with severe valvular heart disease in the mitral or aortic valves
6. LVEF <= 30%
7. Pregnant or lactating patients
8. Patients whose life expectancy is estimated by a physician to be less than 1 year
9. Patients enrolled in other clinical trials or clinical studies involving interventions

Related Information

• Primary Sponsor: Otake Hiromasa
• Source(s) of Monetary Support: CathWorks Japan GK