Functional Assessment of the Infart-related Artery With Bioactive and Polymer-free Coronary Stents (The FUNCOMBO Trial)
NCT ID: NCT04202172
Last Updated: 2020-10-26
Study Results
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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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2018-11-05
2020-09-01
Brief Summary
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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.
Detailed Description
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CD34 antibodies are immobilized on the surface of the stent and capture circulating endothelial progenitor cells (EPCs). The captured EPCs are triggered by sheer stress from the circulating blood and other cell signals to differentiate and mature into endothelial cells. COMBO Plus is the only stent with a biological coating that actively repairs the vessel morphology. However, little is known regarding the endothelial function after stent implantation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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BIOFREEDOM
Implantation of Drug-eluting coronary stent without polymer in patients with myocardial infarction.
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
COMBO
Implantation of Bioactive coronary stent in patients with myocardial infarction.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Spanish Society of Cardiology
OTHER
Institut d'Investigació Biomèdica de Bellvitge
OTHER
Responsible Party
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Josep Gomez Lara
Principal Investigator
Principal Investigators
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Josep Gomez Lara, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari de Bellvitge, L´Hospitalet de Llobregat, Spain
Neus Salvatella, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital del Mar, Barcelona, Spain
Salvatore Brugaletta, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic, Barcelona, Spain
Locations
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Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
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References
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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.
Other Identifiers
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AC009/18
Identifier Type: -
Identifier Source: org_study_id