Vessel Wall Response of the Bio-Active-stent and Everolimus-Eluting Stent Assessed By Optical Coherence Tomography
BASE-OCT
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)
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 3, 2010
CompletedFirst Posted
Study publicly available on registry
March 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedMay 5, 2011
May 1, 2011
1.4 years
March 3, 2010
May 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Uncovered stent struts
OCT number of uncovered stent struts for BAS versus EES.
6-8 months
Secondary Outcomes (1)
Cardiac death,MI, stent thrombosis (ST) and TLR.
1, 6, 12 and 18 months
Study Arms (2)
BAS
Patient's receiving BAS
EES
Patients receiving EES
Interventions
Eligibility Criteria
Patients presenting with acute coronary syndrome and who were treated either BAS or EES during the index PCI.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Satakunta Central Hospital
Pori, 28500, Finland
Related Publications (1)
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.
PMID: 23996244DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pasi P Karjalainen, MD, PhD
Satakunta Central Hospital, Pori, Finland
- STUDY CHAIR
Antti Ylitalo, MD, PhD
Satakunta Central Hospital, Pori, Finland
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 3, 2010
First Posted
March 4, 2010
Study Start
December 1, 2009
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
May 5, 2011
Record last verified: 2011-05