Skip to main content
OpenTrials
Completed

NCT Number: NCT00704145

Optical Coherence Tomography Following Paclitaxel Eluting Stent Implantation in Multivessel Coronary Artery Disease

A prospective Optical Coherence Tomography (OCT) study on the completeness of strut coverage and vessel wall response, at different time points (3-6-9 Months), following TAXUS Liberte stent implantation (staged procedures) in patients with multi vessel native coronary artery lesions

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ospedali Riuniti di Bergamo

Bergamo, 24100, Italy

About this study

Major concerns were addressed to the delayed healing process of drug-eluting stents in off-label indications. To date no studies have detailed the in-vivo completeness of DES coverage at different time points. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response (neointima disomogeneity, acquired late incomplete strut apposition) at different time points following paclitaxel-eluting stent implantation, in patients with multivessel disease treated with staged PCI procedures. Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at different time point. Intravascular ultrasound (IVUS) will be performed as per normal practice at any index procedures and 9 months elective follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Multivessel coronary artery disease (two or 3 VD) to be treated at 2 sequences (staged procedures) with paclitaxel-polymer eluting stents
  • Native coronary artery disease with >= 75% diameter stenosis
  • Vessel size in between 2.5 and 3.5 mm.
  • Written informed consent signed

Exclusion criteria

  • No suitable anatomy for OCT scan: (truly ostial , tortuous anatomy, very distal lesions or vessels larger than 3.75 in reference diameter).
  • significant left main coronary artery disease,
  • lesions in bypass grafts,
  • acute myocardial infarction,
  • poor cardiac function as defined by left ventricular ejection fraction ≤ 30%.
  • allergy to aspirin and or clopidogrel/ticlopidine,
  • Renal failure with creatinine value > 2.5 mg/dl

Treatment and study plan

Taxus Libertè™ paclitaxel drug-eluting stent

Device

device:Taxus Libertè™ (Boston Scientific,Natick,MS)assessed at different time points after implant

Other names: Taxus Libertè™ (Boston Scientific,Natick,MS)

Primary outcomes

  1. Proportion of uncovered and/or malapposed Taxus Libertè struts at different time point after the implant, as measured by OCT

    Time frame: 3-6-9 months

Secondary outcomes

  1. % Incomplete apposition at different point of FU (3-6-9 months)

    Time frame: 3-6-9 months

  2. Proportion of neointima disomogeneity around struts at different point of FU (3-6-9 months)

    Time frame: 3-6-9 months

  3. OCT Neointima thickness overtime

    Time frame: 3-6-9 months

  4. Ischemia Driven Target Vessel Failure (ID-TVF) rate at 12 months

    Time frame: 12 months

  5. Adjudicated MACE rate at 30 days and 12 months

    Time frame: 30 days and 12 months

Sponsors and collaborators

Lead sponsor

A.O. Ospedale Papa Giovanni XXIII

Other

Collaborators

  • Boston Scientific Corporation
  • Case Western Reserve University

Registry information

Official study title

A Prospective Optical Coherence Tomography Study on Completeness of Strut Coverage and Vessel Wall Response at 3-6 and 9 Months Following Paclitaxel Eluting Stent Implantation in Multivessel Coronary Artery Disease

Acronym: OCTAXUS

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jun 24, 2008
Registry last updated
Feb 9, 2010

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.

Published trials that share one or more normalized conditions with this study.