Clinical trial NCT01080859: Vessel Wall Response of the Bio-Active-stent and Everolimus-Eluting Stent Assessed By Optical Coherence Tomography
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: titanium
everolimus
oct
acute coronary syndrome
stent
pci
stenting
Lead sponsor: The Hospital District of Satakunta
Sponsor class: OTHER
First posted: 2010-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with acute coronary syndrome and who were treated either BAS or EES during the index PCI.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Uncovered stent struts
timeFrame: 6-8 months
Secondary outcomes:
measure: Cardiac death,MI, stent thrombosis (ST) and TLR.
timeFrame: 1, 6, 12 and 18 months
Other outcomes:
Locations:
city: Pori
country: Finland
facility: Satakunta Central Hospital
Study officials:
affiliation: Satakunta Central Hospital, Pori, Finland
name: Pasi P Karjalainen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Satakunta Central Hospital, Pori, Finland
name: Antti Ylitalo, MD, PhD
role: STUDY_CHAIR
References:
citation: Karjalainen P, Kiviniemi TO, Lehtinen T, Nammas W, Ylitalo A, Saraste A, Mikkelsson J, Pietila M, Biancari F, Airaksinen JK. Neointimal coverage and vasodilator response to titanium-nitride-oxide-coated bioactive stents and everolimus-eluting stents in patients with acute coronary syndrome: insights from the BASE-ACS trial. Int J Cardiovasc Imaging. 2013 Dec;29(8):1693-703. doi: 10.1007/s10554-013-0285-8. Epub 2013 Aug 31.