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

Institut d'Investigació Biomèdica de Bellvitge

Status and phase

Completed

Phase 4

Conditions

Coronary Microvascular Disease

Endothelial Dysfunction

Myocardial Infarction

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04202172

AC009/18

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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