Ignite Creation Date:
2025-12-17 @ 3:41 PM
Ignite Modification Date:
2025-12-23 @ 7:03 PM
Study NCT ID:
NCT00776204
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2008-10-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Optical Coherence Tomography Drug Eluting Stent Investigation
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
The Optical Coherence Tomography Drug Eluting Stent Investigation(OCTDESI)
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OCTDESI
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: