Drug-coated balloon (Sequent Please Neo) vs drug-eluting stent treatment for acute ST-elevation myocardial infarction: a randomised trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16341009

Enrollment

700

Registered

2025-07-15

Start date

2025-10-13

Completion date

Unknown

Last updated

2026-08-31

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

Conditions

Acute ST-elevation myocardial infarction Circulatory System

Interventions

The study is an investigator-initiated, prospective, open-label, randomised, non-inferiority study. The study will be conducted across multiple primary angioplasty (heart attack) centres within the U

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: This trial presents an all-comers design allowing broad inclusion and few exclusion criteria. Specifically, patients can be included if suffering from STEMI, which requires emergent percutaneous coronary intervention (PCI) via the primary angioplasty service. To meet the criteria of a STEMI, patients need to have: 1. Symptoms of myocardial ischemia lasting for =30 min 2. Definite ECG changes indicating STEMI: ST elevation of >0.1 mV in two contiguous limb leads or =0.2 mV in two contiguous precordial leads

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 06/01/2026: 1. Previous CABG Previous exclusion criteria: 1. Prior PCI of the target vessel 2. Previous CABG 3. Recent (<2 months) history of significant bleeding 4. Cardiac arrest requiring intubation before PPCI 5. Known allergy or contraindication for aspirin, clopidogrel, prasugrel, fondaparinux and/or heparin 6. Life expectancy less than 12 months

Design outcomes

Primary

Measure	Time frame
Target vessel failure measured using a composition of cardiac death, target vessel revascularisation and target vessel myocardial infarction at 1 year	—

Secondary

Measure	Time frame
1. Pre-discharge LV function, measured using a transthoracic echo at pre-discharge 2. Length of stay, measured using hospital admission duration 3. Bleeding measured using the BARC scale during inpatient admission and follow-up 4. Non-cardiac death, measured using the death certificate and determining non-cardiac death during inpatient admission 5. Acute and subacute vessel closure/stent thrombosis, measured using an angiogram during the inpatient admission 6. Contrast and radiation dose, measured during the procedure 7. Procedural time, measured during the procedure Measured at follow-up at 30 days, 1 year, 3 years and 5 years: 1. Target vessel failure and presence of reintervention, measured using a composition of cardiac death, target vessel revascularisation and target vessel myocardial infarction during follow-up 2. All-cause mortality measured using COD information on a death certificate 3. Non-cardiac mortality measured using COD information on a death certificate 4. Revascularisation of the non-target vessel measured using an angiogram and PCI to the non-target vessel 5. Net-clinical benefit: freedom from target vessel failure and bleeding measured using the BARC 3-5 bleeding scale	—

Measure

Time frame

1. Pre-discharge LV function, measured using a transthoracic echo at pre-discharge 2. Length of stay, measured using hospital admission duration 3. Bleeding measured using the BARC scale during inpatient admission and follow-up 4. Non-cardiac death, measured using the death certificate and determining non-cardiac death during inpatient admission 5. Acute and subacute vessel closure/stent thrombosis, measured using an angiogram during the inpatient admission 6. Contrast and radiation dose, measured during the procedure 7. Procedural time, measured during the procedure Measured at follow-up at 30 days, 1 year, 3 years and 5 years: 1. Target vessel failure and presence of reintervention, measured using a composition of cardiac death, target vessel revascularisation and target vessel myocardial infarction during follow-up 2. All-cause mortality measured using COD information on a death certificate 3. Non-cardiac mortality measured using COD information on a death certificate 4. Revascularisation of the non-target vessel measured using an angiogram and PCI to the non-target vessel 5. Net-clinical benefit: freedom from target vessel failure and bleeding measured using the BARC 3-5 bleeding scale

—

Countries

England, Scotland, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Sep 19, 2026