Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-11

Study Completion Date

2035-09-30

Brief Summary

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The objective is to compare a reduced stent strategy based on drug-coated balloon (DCB) percutaneous coronary intervention (PCI) with conventional drug-eluting stent (DES) coronary revascularization in patients presenting with ST-segment myocardial infarction (STEMI).

Randomization will be performed after successful culprit-lesion guidewire crossing and flow restoration. Random allocation in a 1:1 fashion to one of the following strategies:

* Study group: reduced stent PCI strategy (DCB-based)
* Control group: conventional PCI strategy (DES-based).

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Detailed Description

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Conditions

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ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DCB-based

Reduced stent PCI strategy: Culprit lesion revascularization with DCB will be performed after coronary predilation if residual stenosis ≤30%, lack of dissections \>type B and TIMI 3 flow. If the aforementioned culprit-lesion characteristics are not achieved after DCB-PCI, a DES will be implanted.

Group Type EXPERIMENTAL

Primary PCI

Intervention Type DEVICE

Coronary percutaneous revascularization

DES-based

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Primary PCI

Coronary percutaneous revascularization

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- Patients presenting with STEMI and indication to undergo pPCI.

Exclusion Criteria

* Life expectancy \<1 year due 1 to non-cardiac disease.
* Inability to provide informed consent.
* Cardiogenic shock.
* Left ventricular ejection fraction \<15%.
* Left main disease.
* Stent thrombosis
* Patients with prior bypass graft lesions requiring PCI (culprit or non culprit lesions).
* Patients with chronic total occlusions.
* Untreatable coronary disease.
* Non-identified culprit lesion.
* Known allergy to aspirin, ticagrelor, prasugrel, clopidogrel, paclitaxel or sirolimus.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jorge Sanz Sanchez

Interventional cardiologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jorge Sanz Sánchez, PI

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Fe

Ignacio J Amat Santos, PI

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Valladolid

Locations

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Hospital Universitario Y Politecnico La Fe

Valencia, Valencia, Spain

Site Status RECRUITING