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

Myocardial Infarction Clinical Trial

— FUNCOMBO  

Official title:

Six-month Endothelial and Microcirculatory Function of the Bioactive Sirolimus-eluting Combo Stent Versus the Polymer-free Biolimus-eluting Biofreedom Stent in Patients With ST-segment Elevation Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04202172
• Other study ID #: AC009/18
• Status: Completed
• Phase: Phase 4
• Start date: November 5, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: October 2020
• Source: Institut d'Investigació Biomèdica de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The bioengineered COMBO stent (Orbus Neich, Fort Lauderdale, Florida, United States) has a dual-therapy strategy, which combines a sirolimus-eluting coating with an anti-CD34 antibody layer to promote vessel healing. Sirolimus release (5 μg/mm) is completed in 30 days, and the biodegradable polymer disappears within 90 days.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Coronary Microvascular Disease
• Endothelial Dysfunction
• Infarction
• Microvascular Angina
• Myocardial Infarction

Intervention

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: Endothelial function assessment with intracoronary acetyl-choline infusion. Microcirculatory function assessment with a pressure wire during endovenous adenosine infusion. Stent healing assessment using optical coherence tomography

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	L'Hospitalet De Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Bellvitge	Sociedad Española de Cardiología

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fractional flow reserve	To compare the fractional flow reserve (FFR) between the culprit arteries treated with COMBO vs. BIOFREEDOM in STEMI patients	At 6 months of the stent implantation
Primary	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	Index of microcirculatory resistance	To compare the index of microcirculatory resistance (IMR) between the culprit arteries treated with COMBO vs. BIOFREEDOM in STEMI patients.	At 6 months of the stent implantation
Secondary	Coronary flow reserve	To compare the coronary flow reserve (CFR) between the culprit arteries treated with COMBO vs. BIOFREEDOM in STEMI patients	At 6 months of the stent implantation