A randomized controlled study of the Prevail Drug-Coated Balloon in subjects with in-stent restenosis and a single arm prospectively enrolled study of the Prevail Drug-Coated Balloon for de novo lesions in small vessel disease

A randomized controlled study of the Prevail Drug-Coated Balloon in subjects with in-stent restenosis and a single arm prospectively enrolled study of the Prevail Drug-Coated Balloon for de novo lesions in small vessel disease - Prevail Global

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2032240716

Enrollment

Registered

2025-03-05

Start date

2025-03-10

Completion date

Unknown

Last updated

2025-07-18

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

Conditions

In-stent restenosis (ISR) and de novo lesions in small vessel diseas

Interventions

PCI using DCB (ISR:MDT-0124 DCB/Agent DCB, DNSV: MDT-0124 DCB)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subject has documented stable or unstable angina, positive functional test, or non-ST elevation myocardial infarction which, in the judgment of the operator, is attributable to disease in a small coronary vessel or in-stent restenosis, and the subject is deemed an appropriate candidate for PCI in accordance with the applicable guidelines on percutaneous coronary intervention.

Exclusion criteria

Exclusion criteria: - Acute Myocardial Infarction within the previous 72 hours (NSTEMI allowed, provided enzymes trending down or are within normal limits) - Target vessel with presence of thrombus - ISR Cohort only: Planned treatment of 3+ layer ISR lesion

Design outcomes

Primary

Measure	Time frame
Target lesion failure (TLF), defined as a composite of cardiac death, target vessel MI, or clinically-driven target lesion revascularization (cd-TLR), at 12 months post procedure ISR Cohort Primary Analysis: - The TLF rate of the Prevail DCB arm at 12 months post procedure compared to the Agent DCB arm for non-inferiority DNSV Cohort Primary Analysis: - The TLF rate of the Prevail DCB arm at 12 months post procedure compared to a DES historical control	—

Measure

Time frame

Target lesion failure (TLF), defined as a composite of cardiac death, target vessel MI, or clinically-driven target lesion revascularization (cd-TLR), at 12 months post procedure ISR Cohort Primary Analysis: - The TLF rate of the Prevail DCB arm at 12 months post procedure compared to the Agent DCB arm for non-inferiority DNSV Cohort Primary Analysis: - The TLF rate of the Prevail DCB arm at 12 months post procedure compared to a DES historical control

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Secondary

Measure	Time frame
The following to be assessed at hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months unless otherwise specified. - Acute success (device, lesion, and procedure) through hospital discharge only - All deaths - Cardiac death - All myocardial infarction (MI), including target vessel myocardial infarction (TVMI) - Clinically-driven target lesion revascularization (cd-TLR) defined as repeat PCI or CABG to the target lesion - Clinically-driven target vessel revascularization (cd-TVR) defined as repeat PCI or CABG to the target vessel - Major adverse cardiac event (MACE) defined as composite of death, MI, or repeat cd-TLR - Target lesion failure (TLF) defined as composite of cardiac death, TVMI, or cd-TLR - Target vessel failure (TVF) defined as composite of cardiac death, TVMI, or cd-TVR - Target lesion thrombosis (TLT) (definite or probable) according to Academic Research Consortium (ARC) definition NOTE: Spontaneous myocardial infarctions will be assessed by the Fourth Universal Definition of Myocardial Infarction; peri-procedural myocardial infarctions will be assessed by the SCAI definition and will utilize CK-MB results processed by a central laboratory for adjudication purposes.	—

Measure

Time frame

The following to be assessed at hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months unless otherwise specified. - Acute success (device, lesion, and procedure) through hospital discharge only - All deaths - Cardiac death - All myocardial infarction (MI), including target vessel myocardial infarction (TVMI) - Clinically-driven target lesion revascularization (cd-TLR) defined as repeat PCI or CABG to the target lesion - Clinically-driven target vessel revascularization (cd-TVR) defined as repeat PCI or CABG to the target vessel - Major adverse cardiac event (MACE) defined as composite of death, MI, or repeat cd-TLR - Target lesion failure (TLF) defined as composite of cardiac death, TVMI, or cd-TLR - Target vessel failure (TVF) defined as composite of cardiac death, TVMI, or cd-TVR - Target lesion thrombosis (TLT) (definite or probable) according to Academic Research Consortium (ARC) definition NOTE: Spontaneous myocardial infarctions will be assessed by the Fourth Universal Definition of Myocardial Infarction; peri-procedural myocardial infarctions will be assessed by the SCAI definition and will utilize CK-MB results processed by a central laboratory for adjudication purposes.

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Countries

France, Germany, Hong Kong, Ireland, Japan, Korea, Singapore, United Kingdom, United States

Contacts

Public ContactTakashi Hamajima

Medtronic Japan

takashi.hamajima@medtronic.com+81-70-1356-0767

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026