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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00704145

Acronym

OCTAXUS

Enrollment

Registered

2008-06-24

Start date

2007-11-30

Completion date

2009-11-30

Last updated

2010-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Drug Eluting Stents, Percutaneous Coronary Interventions, Optical Coherence Tomography

Brief summary

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

Detailed description

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.

Interventions

DEVICETaxus Libertè™ paclitaxel drug-eluting stent

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Multivessel coronary artery disease (two or 3 VD) to be treated at 2 sequences (staged procedures) with paclitaxel-polymer eluting stents 2. Native coronary artery disease with \>= 75% diameter stenosis 3. Vessel size in between 2.5 and 3.5 mm. 4. Written informed consent signed

Exclusion criteria

1. No suitable anatomy for OCT scan: (truly ostial , tortuous anatomy, very distal lesions or vessels larger than 3.75 in reference diameter). 2. significant left main coronary artery disease, 3. lesions in bypass grafts, 4. acute myocardial infarction, 5. poor cardiac function as defined by left ventricular ejection fraction ≤ 30%. 6. allergy to aspirin and or clopidogrel/ticlopidine, 7. Renal failure with creatinine value \> 2.5 mg/dl

Design outcomes

Primary

Measure	Time frame
Proportion of uncovered and/or malapposed Taxus Libertè struts at different time point after the implant, as measured by OCT	3-6-9 months

Secondary

Measure	Time frame
Proportion of neointima disomogeneity around struts at different point of FU (3-6-9 months)	3-6-9 months
% Incomplete apposition at different point of FU (3-6-9 months)	3-6-9 months
OCT Neointima thickness overtime	3-6-9 months
Ischemia Driven Target Vessel Failure (ID-TVF) rate at 12 months	12 months
Adjudicated MACE rate at 30 days and 12 months	30 days and 12 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026