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

Primary Purpose

Endothelial Dysfunction, Coronary Microvascular Disease, Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Stent implantation in the infart-related artery in patients with ST elevation myocardial infarction
Sponsored by
Institut d'Investigació Biomèdica de Bellvitge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endothelial Dysfunction focused on measuring endothelial function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Universitari de Bellvitge

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

BIOFREEDOM

COMBO

Arm Description

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

Implantation of Bioactive coronary stent in patients with myocardial infarction.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Index of microcirculatory resistance
To compare the index of microcirculatory resistance (IMR) between the culprit arteries treated with COMBO vs. BIOFREEDOM in STEMI patients.
Coronary flow reserve
To compare the coronary flow reserve (CFR) between the culprit arteries treated with COMBO vs. BIOFREEDOM in STEMI patients

Full Information

First Posted
October 28, 2018
Last Updated
October 23, 2020
Sponsor
Institut d'Investigació Biomèdica de Bellvitge
Collaborators
Spanish Society of Cardiology
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1. Study Identification

Unique Protocol Identification Number
NCT04202172
Brief Title
Functional Assessment of the Infart-related Artery With Bioactive and Polymer-free Coronary Stents (The FUNCOMBO Trial)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut d'Investigació Biomèdica de Bellvitge
Collaborators
Spanish Society of Cardiology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Dysfunction, Coronary Microvascular Disease, Myocardial Infarction
Keywords
endothelial function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIOFREEDOM
Arm Type
Active Comparator
Arm Description
Implantation of Drug-eluting coronary stent without polymer in patients with myocardial infarction.
Arm Title
COMBO
Arm Type
Experimental
Arm Description
Implantation of Bioactive coronary stent in patients with myocardial infarction.
Intervention Type
Procedure
Intervention Name(s)
Stent implantation in the infart-related artery in patients with ST elevation myocardial infarction
Other Intervention Name(s)
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
Intervention Description
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
Primary Outcome Measure Information:
Title
Endothelial function of the distal coronary segment of patients with myocardial infarction treated with two types of drug-eluting stents
Description
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.
Time Frame
At 6 months of the stent implantation
Secondary Outcome Measure Information:
Title
Index of microcirculatory resistance
Description
To compare the index of microcirculatory resistance (IMR) between the culprit arteries treated with COMBO vs. BIOFREEDOM in STEMI patients.
Time Frame
At 6 months of the stent implantation
Title
Coronary flow reserve
Description
To compare the coronary flow reserve (CFR) between the culprit arteries treated with COMBO vs. BIOFREEDOM in STEMI patients
Time Frame
At 6 months of the stent implantation
Other Pre-specified Outcome Measures:
Title
Fractional flow reserve
Description
To compare the fractional flow reserve (FFR) between the culprit arteries treated with COMBO vs. BIOFREEDOM in STEMI patients
Time Frame
At 6 months of the stent implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Gomez Lara, MD PhD
Organizational Affiliation
Hospital Universitari de Bellvitge, L´Hospitalet de Llobregat, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neus Salvatella, MD
Organizational Affiliation
Hospital del Mar, Barcelona, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Salvatore Brugaletta, MD PhD
Organizational Affiliation
Hospital Clinic, Barcelona, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33640311
Citation
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.
Results Reference
derived

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

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