Coronary Flow Reserve in Patients With Bio-active Stent or Everolimus-eluting Stent Implanted in Acute Coronary Syndrome

The Hospital District of Satakunta40 enrolled

Overview

The aim of the trial is to assess coronary artery reactivity using adenosine-induced coronary flow reserve (CFR) by transthoracic echocardiography in patients with Bio-active stent (BAS) and Everolimus-eluting stent (EES) distal to the original culprit lesion at 6-8 months.

Objective: The aim of the trial is to assess coronary artery reactivity using adenosine-induced coronary flow reserve (CFR) by transthoracic echocardiography in patients with Bio-active stent (BAS) and Everolimus-eluting stent (EES) distal to the original culprit lesion at 6-8 months. Design: BASE-CFR is a substudy of the larger randomized multicenter BASE-ACS trial comparing bio-active Titan stent to everolimus-eluting stent in patients with acute coronary syndrome. CFR assessment will be performed at 6-8 months after stent implantation at the same time with OCT assessment. In-stent restenosis will be ruled out using OCT. Primary endpoint: CFR at 6-8 months after stent implantation. Secondary endpoint: Coronary flow velocity at baseline and during adenosine-induced hyperemia 6-8 months after stent implantation.. Association of CFR to unendotheliazed stent struts and stent malapposition. Enrollment: 40 patients (20 receiving BAS and 20 receiving EES). Clinical site: Satakunta Central Hospital, Finland Turku University Hospital, Finland

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acute Coronary Syndrome

Interventions

CFRDEVICE

CFR will be assessed using transthoracic echocardiography with adenosine infusion.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient is enrolled to the BASE-ACS trial. Treated culprit lesion is in the proximal or middle LAD * Patient or the patient's legal representative has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Ethics Committee of the respective clinical site Exclusion Criteria: * Diabetes mellitus * Treated stent position other than LAD proximal or middle. * EF\<30% * Bifurcation lesions * Renal impairment (creatinine \>120 mmol/L) * No suitable anatomy for OCT scan or CFR measurement

Locations (2)

Satakunta Central Hospital

Pori, Finland

Turku University Hospital

Turku, Finland

Outcomes

Primary Outcomes

Coronary flow reserve (CFR)

CFR at 6-8 months after stent implantation

Time frame: 6-8 months after stent implantation

Secondary Outcomes

Coronary flow velocity

Time frame: at baseline and during adenosine-induced hyperemia

Association of CFR to unendotheliazed stent struts and stent malapposition

Time frame: 6-8 months

Data from ClinicalTrials.gov

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