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

A.O. Ospedale Papa Giovanni XXIII

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: Taxus Libertè™ paclitaxel drug-eluting stent

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00704145

1087/2007

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

A

Experimental group

Description:

Device, paclitaxel drug-eluting stent

Treatment:

Device: Taxus Libertè™ paclitaxel drug-eluting stent