Myocardial Infarction Clinical Trial
— FUNCOMBOOfficial 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
Verified date | October 2020 |
Source | Institut d'Investigació Biomèdica de Bellvitge |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitari de Bellvitge | L'Hospitalet De Llobregat | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Institut d'Investigació Biomèdica de Bellvitge | Sociedad Española de Cardiología |
Spain,
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 |
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