Vessel Wall Response of the Bio-Active-stent and Everolimus-Eluting Stent Assessed By Optical Coherence Tomography

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Device: OCT

• Registration Number: NCT01080859
• Lead Sponsor: The Hospital District of Satakunta

Brief Summary

The purpose of the trial is to evaluate the completeness of struts coverage and vessel wall response (strut malapposition, neoin-timal formation) to the bio-active-stent (BAS) versus ever-olimus-eluting stent (EES) implanted for the treatment of the culprit lesion in acute coronary syndrome.

Detailed Description

A prospective, randomized and controlled study comparing the coverage of the BAS and EES implanted in acute coronary syndrome.

Clinical follow-up at 1, 6, 12 and 18 months. OCT analysis at the time of the 6 to 8 months follow-up.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-03-03
• Study First Submitted QC: 2010-03-03
• Study First Posted: 2010-03-04
• Status Verified: 2011-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Last Update Submitted: 2011-05-04
• Last Update Posted: 2011-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patient is ≥ 18 years old;
• The patient is presenting with acute coronary syndrome, and according to hospital routine practice, eligible for percutaneous coronary intervention;
• 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

• Lesions in coronary artery bypass grafts
• Left main disease
• Killip class III-IV
• Allergy to aspirin / thienopyridine
• Patient in anticoagulation therapy
• No suitable anatomy for OCT scan
• Ostial lesion
• Tortuosity anatomy
• Very distal lesion
• Vessel size > 3.75 mm

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BAS	OCT	Patient's receiving BAS
EES	OCT	Patients receiving EES

Primary Outcome Measures

Name	Time	Method
Uncovered stent struts	6-8 months	OCT number of uncovered stent struts for BAS versus EES.

Secondary Outcome Measures

Name	Time	Method
Cardiac death,MI, stent thrombosis (ST) and TLR.	1, 6, 12 and 18 months	Device oriented composite endpoint, defined as cardiac death,MI, stent thrombosis (ST) and TLR at at 1, 6, 12 and 18 months.

Trial Locations

Locations (1)

Satakunta Central Hospital; 🇫🇮 Pori, Finland