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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01080859

Acronym

BASE-OCT

Enrollment

Registered

2010-03-04

Start date

2009-12-31

Completion date

2011-05-31

Last updated

2011-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

titanium, everolimus, oct, acute coronary syndrome, stent, pci, stenting

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.

Interventions

DEVICEOCT

Optical coherence tomography

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Uncovered stent struts	6-8 months	OCT number of uncovered stent struts for BAS versus EES.

Secondary

Measure	Time frame	Description
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.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026