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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Coronary Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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BAS

Patient's receiving BAS

OCT

Intervention Type DEVICE

Optical coherence tomography

EES

Patients receiving EES

OCT

Intervention Type DEVICE

Optical coherence tomography

Interventions

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OCT

Optical coherence tomography

Intervention Type DEVICE

OCT

Optical coherence tomography

Intervention Type DEVICE

Other Intervention Names

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TITAN-2, Hexacath, France Xience-V, Abbott vascular, USA

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No