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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01080872

Acronym

BASE-CFR

Enrollment

Registered

2010-03-04

Start date

2009-12-31

Completion date

2011-05-31

Last updated

2011-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

acute coronary syndrome, coronary flow reserve, OCT, healing, drug eluting stent

Brief summary

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.

Detailed description

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

Interventions

DEVICECFR

CFR will be assessed using transthoracic echocardiography with adenosine infusion.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Coronary flow reserve (CFR)	6-8 months after stent implantation	CFR at 6-8 months after stent implantation

Secondary

Measure	Time frame
Coronary flow velocity	at baseline and during adenosine-induced hyperemia
Association of CFR to unendotheliazed stent struts and stent malapposition	6-8 months

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026