NCT04202172

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Institut d'Investigació Biomèdica de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Endothelial Dysfunction
• Coronary Microvascular Disease
• Myocardial Infarction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-11-05
• Primary completion: 2020-03-01
• Completion: 2020-09-01
• First posted: 2019-12-17
• Last updated: 2020-10-26

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated drug study
• FDA-regulated device study