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Completed

NCT Number: NCT01080872

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

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.

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Key information

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Satakunta Central Hospital, Pori, Finland

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CFR

Device

CFR will be assessed using transthoracic echocardiography with adenosine infusion.

Other names: Xience-V stent, Abbott vascular, USA

Primary outcomes

  1. Coronary flow reserve (CFR)

    Time frame: 6-8 months after stent implantation

    CFR at 6-8 months after stent implantation

Secondary outcomes

  1. Coronary flow velocity

    Time frame: at baseline and during adenosine-induced hyperemia

  2. Association of CFR to unendotheliazed stent struts and stent malapposition

    Time frame: 6-8 months

Sponsors and collaborators

Lead sponsor

The Hospital District of Satakunta

Other

Registry information

Acronym: BASE-CFR

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 4, 2010
Registry last updated
May 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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