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

A.O. Ospedale Papa Giovanni XXIII30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

Taxus Libertè™ paclitaxel drug-eluting stentDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ospedali Riuniti di Bergamo

Bergamo, Italy

Outcomes

Primary Outcomes

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

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

Time frame: 3-6-9 months

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

Time frame: 3-6-9 months

OCT Neointima thickness overtime

Time frame: 3-6-9 months

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

Time frame: 12 months

Adjudicated MACE rate at 30 days and 12 months

Time frame: 30 days and 12 months

Data from ClinicalTrials.gov

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