Endothelial DysfunctionPhase 4FUNCOMBONCT04202172

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

A Phase 4 study testing Stent implantation in the infart-related artery in patients with ST elevation myocardial infarction in people with Endothelial Dysfunction and Coronary Microvascular Disease, run by Institut d'Investigació Biomèdica de Bellvitge at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Endothelial Dysfunction, Coronary Microvascular Disease, Myocardial Infarction
What is being tested?: Stent implantation in the infart-related artery in patients with ST elevation myocardial infarction
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteSpain
Study dates: 5 Nov 2018to 1 Sep 2020
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907

Other trials in Spain

About this study

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

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.

Read the 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
Being tested: Stent implantation in the infart-related artery in patients with ST elevation myocardial infarction
Keywords: endothelial function
Medical subject headings: Microvascular Angina, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stent implantation in the infart-related artery in patients with ST elevation myocardial infarctionProcedure or surgery
Also called 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
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

Study groups in NCT04202172
Study group	Role	What they receive
BIOFREEDOM	Active comparator	Implantation of Drug-eluting coronary stent without polymer in patients with myocardial infarction. Receives: Procedure: Stent implantation in the infart-related artery in patients with ST elevation myocardial infarction
COMBO	Experimental	Implantation of Bioactive coronary stent in patients with myocardial infarction. Receives: Procedure: Stent implantation in the infart-related artery in patients with ST elevation myocardial infarction

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At 6 months of the stent implantation

Secondary outcomes (2)

Index of microcirculatory resistance
To compare the index of microcirculatory resistance (IMR) between the culprit arteries treated with COMBO vs. BIOFREEDOM in STEMI patients.
Measured: At 6 months of the stent implantation
Coronary flow reserve
To compare the coronary flow reserve (CFR) between the culprit arteries treated with COMBO vs. BIOFREEDOM in STEMI patients
Measured: At 6 months of the stent implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 20181 Sep 2020

First posted17 Dec 2019
Study start5 Nov 2018
Primary completion1 Mar 2020
Study completion1 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04202172
Sponsor's protocol ID: AC009/18
Acronym: FUNCOMBO
Status last verified: Oct 2020
First submitted: 28 Oct 2018
Last updated: 26 Oct 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 33640311

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04202172
Acronym / sponsor ID: FUNCOMBO / AC009/18
Conditions: Endothelial Dysfunction, Coronary Microvascular Disease, Myocardial Infarction
Keywords: endothelial function
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Institut d'Investigació Biomèdica de BellvitgeUniversity, hospital or other
Collaborators: Spanish Society of Cardiology
Study start: 5 Nov 2018 (actual)
Primary completion: 1 Mar 2020 (actual)
Study completion: 1 Sep 2020 (actual)
First posted: 17 Dec 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
BIOFREEDOM	Active comparator	Procedure: Stent implantation in the infart-related artery in patients with ST elevation myocardial infarctionImplantation of Drug-eluting coronary stent without polymer in patients with myocardial infarction.
COMBO	Experimental	Procedure: Stent implantation in the infart-related artery in patients with ST elevation myocardial infarctionImplantation of Bioactive coronary stent in patients with myocardial infarction.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Stent implantation in the infart-related artery in patients with ST elevation myocardial infarctionAlso: 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 arteryThe 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	Procedure or surgery	BIOFREEDOM, COMBO

Primary outcome

Endothelial function of the distal coronary segment of patients with myocardial infarction treated with two types of drug-eluting stents
Time frame: At 6 months of the stent implantation
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.

2 secondary outcomes

Index of microcirculatory resistance
Time frame: At 6 months of the stent implantation
Coronary flow reserve
Time frame: At 6 months of the stent implantation

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
Derived from this study: PubMed 33640311Gomez-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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Josep Gomez Lara, MD PhD principal investigator

Hospital Universitari de Bellvitge, L´Hospitalet de Llobregat, Spain

Neus Salvatella, MD principal investigator

Hospital del Mar, Barcelona, Spain

Salvatore Brugaletta, MD PhD principal investigator

Hospital Clinic, Barcelona, Spain

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endothelial function of the distal coronary segment of patients with myocardial infarction treated with two types of drug-eluting stents (time frame: At 6 months of the stent implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04202172, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.