The Optical Coherence Tomography Drug Eluting Stent Investigation

NCT00776204 | Completed DMC

• 1 other identifier: LBCT-H03-07
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Drug eluting stent; Percutaneous Coronary Interventions; Optical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

• Proportion of stent struts uncovered and/or malapposed at OCT

  6 months

Secondary Outcomes (6)

• Major Adverse Cardiac Events (MACE)

  12 and 24 months

• Stent Thrombosis

  12 and 24 months

• Target Lesion Revascularization

  12 and 24 months

• Procedural success

  through discharge

• QCA parameters: mean lumen diameter, acute gain, late loss and binary restenosis (≥ 50% diameter stenosis) rate

  6 months

Study Arms (3)

1

ACTIVE COMPARATOR

Drug Eluting Stent

Device: JACTAX Drug eluting stent

2

ACTIVE COMPARATOR

Drug Eluting Stent

Device: JACTAX LD drug eluting stent

3

ACTIVE COMPARATOR

Drug Eluting Stent

Device: Taxus Libertè

Interventions

JACTAX Drug eluting stent DEVICE

Jactax stent placed in coronary artery

Also known as: JACTAX Drug eluting stent (Labcoat Ltd, Galway, Ireland)

1

JACTAX LD drug eluting stent DEVICE

JACTAX LD stent placed in coronary artery

Also known as: JACTAX LD Drug eluting stent (Labcoat Ltd, Galway, Ireland)

2

Taxus Libertè DEVICE

Taxus Libertè stent placed in coronary artery

Also known as: Taxus Libertè (Boston Scientific, Natick, MA)

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥ 18 years of age
• Patient is eligible for percutaneous coronary intervention (PCI)
• Patient demonstrates a left ventricular ejection fraction (LVEF) of ≥ 25%
• Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written Informed Consent to this effect.
• 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
• A second lesion in a second vessel may be treated with one (1) TAXUS™ Libertè™ DES or a bare metal stent.

You may not qualify if:

• The patient has a life expectancy of less than 24 months due to another medical condition
• Patient has a history of hypersensitivity to paclitaxel or structurally related compounds
• 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
• Patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine \> 2.0 mg/dl or177 µmol/l)
• Planned cardiac surgery procedure ≤ 6 months post-index procedure
• 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
• Patient demonstrates evidence of leukopenia (leukocyte count \< 3.5 X 109/liter)
• Patient demonstrates evidence of thrombocytopenia (platelet count \< 100,000/mm3) or thrombocytosis (\>750,000/mm3)
• Patient is currently on warfarin, or possibility of treatment with warfarin during the following 6 months post index procedure
• Patient has been treated with paclitaxel or other chemotherapeutic agents within 12-months prior to planned index procedure
• Anticipated treatment with paclitaxel or oral rapamycin during any period in the 6-months after the index procedure
• Patient has received a drug eluting stent within 12-months prior to planned index procedure
• Previous or planned treatment with intravascular brachytherapy in target vessel
• Known allergy to stainless steel
• 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)

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• Labcoat, Ltd.: collaborator

Study Sites (1)

Ospedali Riuniti di Bergamo

Bergamo, 24128, Italy

Location

Related Publications (9)

• Luscher 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. doi: 10.1161/CIRCULATIONAHA.106.675934.

  PMID: 17325255 BACKGROUND

• 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. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.

  PMID: 17438147 BACKGROUND

• 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.

  PMID: 16003026 BACKGROUND

• 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. doi: 10.1161/01.cir.0000041632.02514.14.

  PMID: 12438288 BACKGROUND

• 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. doi: 10.1016/j.cardiores.2004.04.029.

  PMID: 15306217 BACKGROUND

• 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. doi: 10.1161/01.CIR.0000116202.41966.D4. Epub 2004 Jan 26.

  PMID: 14744976 BACKGROUND

• 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. doi: 10.1093/eurheartj/ehl413. Epub 2006 Nov 29.

  PMID: 17135281 BACKGROUND

• 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. doi: 10.1002/ccd.21606.

  PMID: 18655155 BACKGROUND

• Guagliumi G, Sirbu V, Musumeci G, Bezerra HG, Aprile A, Kyono H, Fiocca L, Matiashvili A, Lortkipanidze N, Vassileva A, Popma JJ, Allocco DJ, Dawkins KD, Valsecchi O, Costa MA. Strut coverage and vessel wall response to a new-generation paclitaxel-eluting stent with an ultrathin biodegradable abluminal polymer: Optical Coherence Tomography Drug-Eluting Stent Investigation (OCTDESI). Circ Cardiovasc Interv. 2010 Aug;3(4):367-75. doi: 10.1161/CIRCINTERVENTIONS.110.950154. Epub 2010 Jul 20.

  PMID: 20647562 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Giulio Guagliumi, MD

  Cardiovascular Department Ospedali Riuniti di Bergamo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2008
• First Posted: October 21, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: February 1, 2011
• Last Updated: March 1, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)