NCT00776204

The Optical Coherence Tomography Drug Eluting Stent Investigation

The Optical Coherence Tomography Drug Eluting Stent Investigation(OCTDESI)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the completeness of struts coverage and vessel wall response to the new generation JACTAX drug-eluting stent vs Taxus stent in de novo coronary artery lesions at 6 months post index procedure. To investigate the completeness of the coverage as well as the number of uncovered stent struts per section, high resolution (\~ 10-15 µm axial) intracoronary Optical Coherence Tomography (OCT) will be used.

Detailed description

The risk of late stent thrombosis represents a major concern for patients treated with first generation drug-eluting stents (DES). Delayed healing and poor endothelialization are common findings in vessels treated with DES and are probably related to the amount of drug and polymer applied to a DES. There is evidence to suggest that polymer applications may influence the processes of inflammation and vessel healing. The JACTAX family of DES have been designed to provide a maximum amount of drug delivered directly to coronary vessel tissue while excluding polymer and drug from contact within the vessel lumen. The JACTAX stents are comprised of a currently marketed bare metal stent (Libertè™) coated exclusively on the ablumenal stent surface with a carrier containing a bioerodable polymer, Polylactide and paclitaxel. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response (strut malapposition, neointima disomogeneities in texture) to the JACTAX stents vs Taxus Libertè in de novo coronary artery lesions at 6 months post index procedure. Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at 6 months follow-up. Intravascular ultrasound (IVUS) will be performed as per normal practice at any index procedures and at 6 months follow-up.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	JACTAX Drug eluting stent	Jactax stent placed in coronary artery
DEVICE	JACTAX LD drug eluting stent	JACTAX LD stent placed in coronary artery
DEVICE	Taxus Libertè	Taxus Libertè stent placed in coronary artery

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-07-01
• Completion: 2011-02-01
• First posted: 2008-10-21
• Last updated: 2017-03-01

Locations

1 site across 1 country: Italy