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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Taxus Libertè™ paclitaxel drug-eluting stent

• Registration Number: NCT00704145
• Lead Sponsor: A.O. Ospedale Papa Giovanni XXIII

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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-06-20
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-24
• Primary Completion: 2009-08
• Study Completion: 2009-11
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-05
• Last Update Posted: 2010-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Taxus Libertè™ paclitaxel drug-eluting stent	Device, paclitaxel drug-eluting stent

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
% Incomplete apposition at different point of FU (3-6-9 months)	3-6-9 months
Proportion of neointima disomogeneity around struts 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

Trial Locations

Locations (1)

Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, Italy