Trials / Completed
CompletedNCT00704145
Optical Coherence Tomography Following Paclitaxel Eluting Stent Implantation in Multivessel Coronary Artery Disease
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- A.O. Ospedale Papa Giovanni XXIII · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Taxus Libertè™ paclitaxel drug-eluting stent | device:Taxus Libertè™ (Boston Scientific,Natick,MS)assessed at different time points after implant |
Timeline
- Start date
- 2007-11-01
- Primary completion
- 2009-08-01
- Completion
- 2009-11-01
- First posted
- 2008-06-24
- Last updated
- 2010-02-09
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT00704145. Inclusion in this directory is not an endorsement.