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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-11-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Device, paclitaxel drug-eluting stent

Group Type EXPERIMENTAL

Taxus Libertè™ paclitaxel drug-eluting stent

Intervention Type DEVICE

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

Interventions

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Taxus Libertè™ paclitaxel drug-eluting stent

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

Intervention Type DEVICE

Other Intervention Names

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Taxus Libertè™ (Boston Scientific,Natick,MS)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No