NCT01080872

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: The Hospital District of Satakunta · Academic / Other
• Sex: All
• Age: 30 Years – 90 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DEVICE	CFR	CFR will be assessed using transthoracic echocardiography with adenosine infusion.

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2010-03-04
• Last updated: 2011-05-05

Locations

2 sites across 1 country: Finland