Ospedali Riuniti di Bergamo
Bergamo, 24100, Italy
NCT Number: NCT00704145
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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Notify Me18 year and older
All sexes
Interventional
Phase 4
Bergamo, 24100, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
device:Taxus Libertè™ (Boston Scientific,Natick,MS)assessed at different time points after implant
Other names: Taxus Libertè™ (Boston Scientific,Natick,MS)
Time frame: 3-6-9 months
Time frame: 3-6-9 months
Time frame: 3-6-9 months
Time frame: 3-6-9 months
Time frame: 12 months
Time frame: 30 days and 12 months
A.O. Ospedale Papa Giovanni XXIII
Other
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
Acronym: OCTAXUS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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