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Completed

NCT Number: NCT01080859

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

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.

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Key information

Conditions

Acute Coronary Syndrome Amino Acid Metabolism, Inborn Errors Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Cardiovascular Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Heart Diseases Metabolic Diseases Metabolism, Inborn Errors Myocardial Ischemia Nervous System Diseases Nutritional and Metabolic Diseases Ornithine Carbamoyltransferase Deficiency Disease Urea Cycle Disorders, Inborn Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Satakunta Central Hospital

Pori, 28500, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OCT

Device

Optical coherence tomography

Other names: TITAN-2, Hexacath, France

Primary outcomes

  1. Uncovered stent struts

    Time frame: 6-8 months

    OCT number of uncovered stent struts for BAS versus EES.

Secondary outcomes

  1. 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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

The Hospital District of Satakunta

Other

Registry information

Official study 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)

Acronym: BASE-OCT

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 4, 2010
Registry last updated
May 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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