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

Sponsor

The Hospital District of Satakunta (Other)

Overall Status

Completed

CT.gov ID

NCT01080859

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Device: OCT Device: OCT

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 Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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)

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
BAS Patient's receiving BAS	Device: OCT Optical coherence tomography Other Names: TITAN-2, Hexacath, France
EES Patients receiving EES	Device: OCT Optical coherence tomography Other Names: Xience-V, Abbott vascular, USA

Arm

Intervention/Treatment

BAS

Patient's receiving BAS

Device: OCT

Optical coherence tomography

Other Names:

TITAN-2, Hexacath, France

EES

Patients receiving EES

Device: OCT

Optical coherence tomography

Other Names:

Xience-V, Abbott vascular, USA

Outcome Measures

Primary Outcome Measures

Uncovered stent struts [6-8 months]
OCT number of uncovered stent struts for BAS versus EES.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Satakunta Central Hospital	Pori		Finland	28500

Sponsors and Collaborators

The Hospital District of Satakunta

Investigators

Principal Investigator: Pasi P Karjalainen, MD, PhD, Satakunta Central Hospital, Pori, Finland
Study Chair: Antti Ylitalo, MD, PhD, Satakunta Central Hospital, Pori, Finland