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Functional Assessment of the Infart-related Artery With Bioactive and Polymer-free Coronary Stents (The FUNCOMBO Trial)

NCT04202172 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-10-26

No results posted yet for this study

Summary

A total of 50 patients with ST-elevation myocardial infarction (STEMI) undergoing primary-percutaneous coronary intervention (PPCI) will be randomized to two different coronary stents: BIOFREEDOM vs. COMBO stent.

All patients will undergo to 6-month scheduled coronary angiography to evaluate the endothelial function response of the distal coronary segment and other functional parameters.

Conditions

Interventions

PROCEDURE

Stent implantation in the infart-related artery in patients with ST elevation myocardial infarction

The 6-month scheduled coronary angiography will perform 3 interventions: 1. Endothelial function assessment with intracoronary acetyl-choline infusion. 2. Microcirculatory function assessment with a pressure wire during endovenous adenosine infusion. 3. Stent healing assessment using optical coherence tomography

Sponsors & Collaborators

  • Spanish Society of Cardiology

    collaborator OTHER

  • Institut d'Investigació Biomèdica de Bellvitge

    lead OTHER

Principal Investigators

  • Josep Gomez Lara, MD PhD · Hospital Universitari de Bellvitge, L´Hospitalet de Llobregat, Spain

  • Neus Salvatella, MD · Hospital del Mar, Barcelona, Spain

  • Salvatore Brugaletta, MD PhD · Hospital Clinic, Barcelona, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-05
Primary Completion
2020-03-01
Completion
2020-09-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04202172 on ClinicalTrials.gov