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The Optical Coherence Tomography Drug Eluting Stent Investigation (OCTDESI)
This study has been completed.

First Received on October 20, 2008.   Last Updated on April 19, 2011   History of Changes
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)

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Proportion of stent struts uncovered and/or malapposed at OCT [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Major Adverse Cardiac Events (MACE) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis [ Time Frame: 12 and 24 months ] [ Designated as safety issue: Yes ]
  • Target Lesion Revascularization [ Time Frame: 12 and 24 months ] [ Designated as safety issue: Yes ]
  • Procedural success [ Time Frame: through discharge ] [ Designated as safety issue: Yes ]
  • QCA parameters: mean lumen diameter, acute gain, late loss and binary restenosis (≥ 50% diameter stenosis) rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • IVUS parameters: neointimal area volume, stent and area volumes, stent apposition, and percent net volume obstruction [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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)
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

General Inclusion Criteria

  1. Patient is ≥ 18 years of age
  2. Patient is eligible for percutaneous coronary intervention (PCI)
  3. Patient demonstrates a left ventricular ejection fraction (LVEF) of ≥ 25%
  4. Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written Informed Consent to this effect.

Angiographic Inclusion Criteria

  1. Target lesion is de novo native coronary artery lesion (i.e., a coronary lesion not previously treated) ≤ 25 mm that can be treated with a single JACTAX, JACTAX LD or TAXUS stent
  2. A second lesion in a second vessel may be treated with one (1) TAXUS™ Libertè™ DES or a bare metal stent.

Exclusion Criteria:

General Exclusion Criteria

  1. The patient has a life expectancy of less than 24 months due to another medical condition
  2. Patient has a history of hypersensitivity to paclitaxel or structurally related compounds
  3. Patient exhibits cardiogenic shock (systolic pressure < 80mm Hg and PCWP > 20mm Hg or cardiac index <1.8 liters/minute/m2 or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure>80 mm Hg) for any time within 24 hours prior to index procedure
  4. Patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine > 2.0 mg/dl or177 µmol/l)
  5. Planned cardiac surgery procedure ≤ 6 months post-index procedure
  6. Patient demonstrates evidence of a acute myocardial infarction (eg. STEMI or enzyme elevation CK > 2X local laboratory's ULN unless CK-MB is < 2X ULN) 7) Cerebrovascular accident (CVA) including stroke or TIA within previous 3 months
  7. Patient demonstrates evidence of leukopenia (leukocyte count < 3.5 X 109/liter)
  8. Patient demonstrates evidence of thrombocytopenia (platelet count < 100,000/mm3) or thrombocytosis (>750,000/mm3)
  9. Patient is contraindicated to ASA (successful prior desensitization to ASA is not an exclusion), clopidogrel, or ticlopidine
  10. Patient is currently on warfarin, or possibility of treatment with warfarin during the following 6 months post index procedure
  11. Patient has been treated with paclitaxel or other chemotherapeutic agents within 12-months prior to planned index procedure
  12. Anticipated treatment with paclitaxel or oral rapamycin during any period in the 6-months after the index procedure
  13. Patient has received a drug eluting stent within 12-months prior to planned index procedure
  14. Previous or planned treatment with intravascular brachytherapy in target vessel
  15. Known allergy to stainless steel
  16. Female or male with known intention to procreate within 3 months after the index procedure (due to the exposure to paclitaxel and unknown affect it may have on the fetus)
  17. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 9 months post index procedure
  18. Patient that in the opinion of the investigator is not clinically appropriate for OCT evaluation.

Angiographic Exclusion Criteria

  1. Evidence of thrombus of the study vessel, based on angiography or IVUS
  2. Study lesion is totally occluded (TIMI flow ≤ 1) either at baseline or before pre-dilatation
  3. Study lesion, or the study vessel proximal to the study lesion is moderately or severely calcified, by visual estimate
  4. Study lesion is ostial in location (within 3.0 mm of vessel origin)
  5. Study lesion involving arterial segments with highly tortuous anatomy or where lesion is located within or distal to a >60 degree bend in the vessel
  6. Study lesion involves a bifurcation with a diseased (>50% stenotic) branch vessel > 2.0 mm in diameter
  7. Left main coronary artery disease (stenosis >50%) whether protected or unprotected
  8. Target lesion length > 25 mm, based on visual estimate by operator
  9. Target vessel diameter > 3.5 mm, based on visual estimate by operator
  10. Target vessel diameter < 2.75 mm based on visual estimate by operator
  11. Pre-treatment of the target lesion (excluding predilation) with another interventional device.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776204

Locations
Italy
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24128
Sponsors and Collaborators
Boston Scientific Corporation
Labcoat, Ltd.
Investigators
Principal Investigator: Giulio Guagliumi, MD Cardiovascular Department Ospedali Riuniti di Bergamo
  More Information

Publications:
Lüscher TF, Steffel J, Eberli FR, Joner M, Nakazawa G, Tanner FC, Virmani R. Drug-eluting stent and coronary thrombosis: biological mechanisms and clinical implications. Circulation. 2007 Feb 27;115(8):1051-8. Review.
Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. Epub 2007 Apr 16.
Kang WC, Han SH, Choi KR, Ahn TH, Shin EK. Acute myocardial infarction caused by late stent thrombosis after deployment of a paclitaxel-eluting stent. J Invasive Cardiol. 2005 Jul;17(7):378-80. No abstract available.
Virmani R, Liistro F, Stankovic G, Di Mario C, Montorfano M, Farb A, Kolodgie FD, Colombo A. Mechanism of late in-stent restenosis after implantation of a paclitaxel derivate-eluting polymer stent system in humans. Circulation. 2002 Nov 19;106(21):2649-51.
Carter AJ, Aggarwal M, Kopia GA, Tio F, Tsao PS, Kolata R, Yeung AC, Llanos G, Dooley J, Falotico R. Long-term effects of polymer-based, slow-release, sirolimus-eluting stents in a porcine coronary model. Cardiovasc Res. 2004 Sep 1;63(4):617-24.
Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004 Feb 17;109(6):701-5. Epub 2004 Jan 26.
Matsumoto D, Shite J, Shinke T, Otake H, Tanino Y, Ogasawara D, Sawada T, Paredes OL, Hirata K, Yokoyama M. Neointimal coverage of sirolimus-eluting stents at 6-month follow-up: evaluated by optical coherence tomography. Eur Heart J. 2007 Apr;28(8):961-7. Epub 2006 Nov 29.
Guagliumi G, Sirbu V. Optical coherence tomography: high resolution intravascular imaging to evaluate vascular healing after coronary stenting. Catheter Cardiovasc Interv. 2008 Aug 1;72(2):237-47. Review.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

Keywords provided by Boston Scientific Corporation:
Coronary Artery Disease
Drug eluting stent
Percutaneous Coronary Interventions
Optical Coherence Tomography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012