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

Acute Coronary Syndrome Clinical Trial

— BASE-OCT  

Official title:

Early Coverage and Vessel Wall Response of the Bio-Active-stent and Everolimus-Eluting Stent Implanted in Acute Coronary Syndrome Assessed By Optical Coherence Tomography (BASE-OCT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080859
• Other study ID #: SA-004
• Status: Completed
• Phase: Phase 3
• First received: March 3, 2010
• Last updated: May 4, 2011
• Start date: December 2009
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: The Hospital District of Satakunta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Device:
• OCT
Optical coherence tomography
• OCT
Optical coherence tomography

Locations

Country	Name	City	State
Finland	Satakunta Central Hospital	Pori

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital District of Satakunta

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncovered stent struts	OCT number of uncovered stent struts for BAS versus EES.	6-8 months	Yes
Secondary	Cardiac death,MI, stent thrombosis (ST) and TLR.	Device oriented composite endpoint, defined as cardiac death,MI, stent thrombosis (ST) and TLR at at 1, 6, 12 and 18 months.	1, 6, 12 and 18 months	Yes