ALLIANCE II Registry

Real world registry of drug coated balloon for coronary artery disease II

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1032250154

Enrollment

900

Registered

2025-06-10

Start date

2025-06-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease/ischemic heart disease

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: -Patients must be 18 years of age or older. -Patients must have given written consent to participate in this study. -Patients are eligible for DCB therapy. -Patients must be at high risk of bleeding according to their attending physician's judgment, and for whom long-term DAPT is not recommended.

Exclusion criteria

Exclusion criteria: -Patients who are ineligible for DCB treatment. -Patients who are participating in other clinical trials or randomized controlled trials (RCTs) using DCBs and therefore find it difficult to participate in this study. -The target lesion is a restenotic lesion after stent placement. -Patients who are judged to require continuous DAPT due to DES placement, etc. -Patients who are scheduled to undergo staged PCI with DES placement after DCB treatment while participating in this study. - Patients who are participating in the ALLIANCE Registry (a real-world registry to evaluate the safety and efficacy of drug-coated balloons (DCBs) for coronary artery disease).

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is the incidence of Net Adverse Clinical Events (NACE) (a composite endpoint of ischemic events (TLF) and bleeding events (BARC 2, 3, or 5)) within 12 months after the procedure. TLF is defined as cardiac death, target vessel-related myocardial infarction (Q waves and non-Q waves), or clinically-driven target lesion revascularization (TLR).	—

Secondary

Measure	Time frame
The incidence of the following clinical endpoints will be evaluated at the time of discharge and at 1, 6, and 12 months after the procedure. -Bleeding according to each type of BARC bleeding criteria -TLF: cardiac death, target vessel-related myocardial infarction (Q waves and non-Q waves), or clinically-driven TLR -Target vessel revascularization (TVR) -Target lesion revascularization (TLR) -Major adverse cardiac events (MACE): cardiac death, non-fatal MI, or TVR -MI (Q waves and non-Q waves) -Cardiac death -Non-cardiac death -All-cause mortality -Vascular death -Target lesion-related thrombus	—

Measure

Time frame

The incidence of the following clinical endpoints will be evaluated at the time of discharge and at 1, 6, and 12 months after the procedure. -Bleeding according to each type of BARC bleeding criteria -TLF: cardiac death, target vessel-related myocardial infarction (Q waves and non-Q waves), or clinically-driven TLR -Target vessel revascularization (TVR) -Target lesion revascularization (TLR) -Major adverse cardiac events (MACE): cardiac death, non-fatal MI, or TVR -MI (Q waves and non-Q waves) -Cardiac death -Non-cardiac death -All-cause mortality -Vascular death -Target lesion-related thrombus

—

Contacts

Public ContactNakamura Masato

Toho University Faculty of Medicine

masato@oha.toho-u.ac.jp+81-3-3762-4151

Outcome results