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

May 4, 2011 updated by: The Hospital District of Satakunta

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Pori, Finland, 28500
        • Satakunta Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BAS
Patient's receiving BAS
Device: OCT
Optical coherence tomography
Other Names:
  • Xience-V, Abbott vascular, USA
EES
Patients receiving EES
Device: OCT
Optical coherence tomography
Other Names:
  • Xience-V, Abbott vascular, USA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1, 6, 12 and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital District of Satakunta

Investigators

  • Principal Investigator: Pasi P Karjalainen, MD, PhD, Satakunta Central Hospital, Pori, Finland
  • Study Chair: Antti Ylitalo, MD, PhD, Satakunta Central Hospital, Pori, Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

March 3, 2010

First Submitted That Met QC Criteria

March 3, 2010

First Posted (Estimate)

March 4, 2010

Study Record Updates

Last Update Posted (Estimate)

May 5, 2011

Last Update Submitted That Met QC Criteria

May 4, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SA-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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