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| Sponsor: | Boston Scientific Corporation |
|---|---|
| Collaborator: |
Labcoat, Ltd. |
| Information provided by: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT00776204 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Coronary Artery Disease |
Device: JACTAX Drug eluting stent Device: JACTAX LD drug eluting stent Device: Taxus Libertè |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Optical Coherence Tomography Drug Eluting Stent Investigation(OCTDESI) |
| Enrollment: | 60 |
| Study Start Date: | May 2008 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Drug Eluting Stent
|
Device: JACTAX Drug eluting stent
Jactax stent placed in coronary artery
Other Name: JACTAX Drug eluting stent (Labcoat Ltd, Galway, Ireland)
|
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Active Comparator: 2
Drug Eluting Stent
|
Device: JACTAX LD drug eluting stent
JACTAX LD stent placed in coronary artery
Other Name: JACTAX LD Drug eluting stent (Labcoat Ltd, Galway, Ireland)
|
|
Active Comparator: 3
Drug Eluting Stent
|
Device: Taxus Libertè
Taxus Libertè stent placed in coronary artery
Other Name: Taxus Libertè (Boston Scientific, Natick, MA)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
General Inclusion Criteria
Angiographic Inclusion Criteria
Exclusion Criteria:
General Exclusion Criteria
Angiographic Exclusion Criteria
Contacts and Locations| Italy | |
| Ospedali Riuniti di Bergamo | |
| Bergamo, Italy, 24128 | |
| Principal Investigator: | Giulio Guagliumi, MD | Cardiovascular Department Ospedali Riuniti di Bergamo |
More Information
| Responsible Party: | Alison Osattin, Program Manager, Boston Scientific |
| ClinicalTrials.gov Identifier: | NCT00776204 History of Changes |
| Other Study ID Numbers: | LBCT-H03-07 |
| Study First Received: | October 20, 2008 |
| Last Updated: | April 19, 2011 |
| Health Authority: | Italy: Ethics Committee; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
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Coronary Artery Disease Drug eluting stent Percutaneous Coronary Interventions Optical Coherence Tomography |
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Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |