Acute Coronary SyndromeBASE-OCTNCT01080859
Vessel Wall Response of the Bio-Active-stent and Everolimus-Eluting Stent Assessed By Optical Coherence Tomography
An observational study of Acute Coronary Syndrome, run by The Hospital District of Satakunta at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- OCT
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2009to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with acute coronary syndrome and who were treated either BAS or EES during the index PCI.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Ostial lesion
- Tortuosity anatomy
- Very distal lesion
- Vessel size > 3.75 mm
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- OCT
- Keywords
- titanium, everolimus, oct, acute coronary syndrome, stent, pci, stenting
- Medical subject headings
- Acute Coronary Syndrome, Ornithine Carbamoyltransferase Deficiency Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTDevice
Also called TITAN-2, Hexacath, France
Optical coherence tomography
OCTDevice
Also called Xience-V, Abbott vascular, USA
Optical coherence tomography
| Study group | Role | What they receive |
|---|---|---|
| BAS | Patient's receiving BAS Receives: Device: OCT | |
| EES | Patients receiving EES Receives: Device: OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncovered stent struts
OCT number of uncovered stent struts for BAS versus EES.
Measured: 6-8 months
Secondary outcomes (1)
Cardiac death,MI, stent thrombosis (ST) and TLR.
Device oriented composite endpoint, defined as cardiac death,MI, stent thrombosis (ST) and TLR at at 1, 6, 12 and 18 months.
Measured: 1, 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startDec 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital District of Satakunta
- Sponsor type
- University, hospital or other
- Investigators
- Pasi P Karjalainen, MD, PhD, Principal investigator, Pori Central HospitalAntti Ylitalo, MD, PhD, Study chair, Pori Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080859
- Sponsor's protocol ID
- SA-004
- Acronym
- BASE-OCT
- Status last verified
- May 2011
- First submitted
- 3 Mar 2010
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23996244
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01080859
- Acronym / sponsor ID
- BASE-OCT / SA-004
- Conditions
- Acute Coronary Syndrome
- Keywords
- titanium, everolimus, oct, acute coronary syndrome, stent, pci, stenting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Hospital District of SatakuntaUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 4 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAS | – | Device: OCTPatient's receiving BAS |
| EES | – | Device: OCTPatients receiving EES |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with acute coronary syndrome and who were treated either BAS or EES during the index PCI.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- Lesions in coronary artery bypass grafts
- Left main disease
- Killip class III-IV
- Allergy to aspirin / thienopyridine
- Patient in anticoagulation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCTAlso: TITAN-2, Hexacath, FranceOptical coherence tomography | Device | BAS |
| OCTAlso: Xience-V, Abbott vascular, USAOptical coherence tomography | Device | EES |
Primary outcome
Uncovered stent struts
Time frame: 6-8 months
OCT number of uncovered stent struts for BAS versus EES.
1 secondary outcome
Cardiac death,MI, stent thrombosis (ST) and TLR.
Time frame: 1, 6, 12 and 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2011.
- Derived from this study: PubMed 23996244Karjalainen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pasi P Karjalainen, MD, PhD principal investigator
Pori Central Hospital
Antti Ylitalo, MD, PhD study chair
Pori Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by The Hospital District of Satakunta at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncovered stent struts (time frame: 6-8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01080859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2011.