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

This study has been completed.
Information provided by:
The Hospital District of Satakunta Identifier:
First received: March 3, 2010
Last updated: May 4, 2011
Last verified: May 2011
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.

Condition Intervention Phase
Acute Coronary Syndrome
Device: OCT
Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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)

Resource links provided by NLM:

Further study details as provided by The Hospital District of Satakunta:

Primary Outcome Measures:
  • Uncovered stent struts [ Time Frame: 6-8 months ]
    OCT number of uncovered stent struts for BAS versus EES.

Secondary Outcome Measures:
  • Cardiac death,MI, stent thrombosis (ST) and TLR. [ Time Frame: 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.

Estimated Enrollment: 40
Study Start Date: December 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patient's receiving BAS
Device: OCT
Optical coherence tomography
Other Name: TITAN-2, Hexacath, France
Patients receiving EES
Device: OCT
Optical coherence tomography
Other Name: Xience-V, Abbott vascular, USA

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.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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
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Please refer to this study by its identifier: NCT01080859

Satakunta Central Hospital
Pori, Finland, 28500
Sponsors and Collaborators
The Hospital District of Satakunta
Principal Investigator: Pasi P Karjalainen, MD, PhD Satakunta Central Hospital, Pori, Finland
Study Chair: Antti Ylitalo, MD, PhD Satakunta Central Hospital, Pori, Finland
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Satakun Hospital District, Satakunta Central Hospital Identifier: NCT01080859     History of Changes
Other Study ID Numbers: SA-004
Study First Received: March 3, 2010
Last Updated: May 4, 2011

Keywords provided by The Hospital District of Satakunta:
acute coronary syndrome

Additional relevant MeSH terms:
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents processed this record on April 28, 2017