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

NCT04202172 | Completed Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: AC009/18
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Endothelial Dysfunction; Coronary Microvascular Disease; Myocardial Infarction

Keywords

endothelial function

Outcome Measures

Primary Outcomes (1)

• Endothelial function of the distal coronary segment of patients with myocardial infarction treated with two types of drug-eluting stents

  To compare the mean lumen diameter changes to intracoronary acetyl-choline infusion of the distal coronary segment by quantitative coronary angiography between the COMBO stent vs. the BIOFREEDOM stent in STEMI patients. Endothelial dysfunction is defined as \>4% vasoconstriction to intracoronary acetylcholine compared to the 6-month baseline mean lumen diameter of the matched segment.

  At 6 months of the stent implantation

Secondary Outcomes (2)

• Index of microcirculatory resistance

  At 6 months of the stent implantation

• Coronary flow reserve

  At 6 months of the stent implantation

Other Outcomes (1)

• Fractional flow reserve

  At 6 months of the stent implantation

Study Arms (2)

BIOFREEDOM

ACTIVE COMPARATOR

Implantation of Drug-eluting coronary stent without polymer in patients with myocardial infarction.

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

COMBO

EXPERIMENTAL

Implantation of Bioactive coronary stent in patients with myocardial infarction.

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

Interventions

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

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

Also known as: All patients will undergo to 6-month coronary angiography after stent implantation in order to assess the endothelial and microvascular function of the infarct related artery

BIOFREEDOM; COMBO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• STEMI \< 12 hours undergoing primary PCI.
• ST-segment elevation of \> 1mm in \> 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of \>1mm in \>2 contiguous anterior leads.
• Presence of at least one acute infarct artery target vessel with one or more de-novo coronary artery stenosis in a native coronary artery within 2.75 - 3.75 mm reference vessel diameter and \< 24 mm length (visually estimated).

You may not qualify if:

• Inability to provide informed consent
• Female of childbearing potential (age \<50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy
• Known intolerance to aspirin, heparin, PLLA, everolimus, contrast material
• Cardiogenic Shock
• Unprotected left main coronary artery stenosis
• Distal occlusion of target vessel
• Acute myocardial infarction secondary to stent thrombosis
• Mechanical complications of acute myocardial infarction
• Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal imaging or excessive risk of complication in the follow-up procedure
• Active bleeding or coagulopathy or patients at chronic anticoagulation therapy
• Chronic renal dysfunction with creatinine clearance \< 45 ml/minm2
• Subject is currently participating in another clinical trial that has not yet completed its primary endpoint

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Bellvitge: lead
• Spanish Society of Cardiology: collaborator

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (1)

• Gomez-Lara J, Oyarzabal L, Brugaletta S, Salvatella N, Romaguera R, Roura G, Fuentes L, Perez Fuentes P, Ortega-Paz L, Ferreiro JL, Teruel L, Gracida M, Vaquerizo B, Sabate M, Comin-Colet J, Gomez-Hospital JA. Coronary endothelial and microvascular function distal to polymer-free and endothelial cell-capturing drug-eluting stents. The randomized FUNCOMBO trial. Rev Esp Cardiol (Engl Ed). 2021 Dec;74(12):1013-1022. doi: 10.1016/j.rec.2021.01.007. Epub 2021 Feb 24. English, Spanish.

  PMID: 33640311 DERIVED

MeSH Terms

Conditions

Microvascular Angina; Myocardial Infarction

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Josep Gomez Lara, MD PhD

  Hospital Universitari de Bellvitge, L´Hospitalet de Llobregat, Spain

  PRINCIPAL INVESTIGATOR

• Neus Salvatella, MD

  Hospital del Mar, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

• Salvatore Brugaletta, MD PhD

  Hospital Clinic, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2018
• First Posted: December 17, 2019
• Study Start: November 5, 2018
• Primary Completion: March 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)