Status:
COMPLETED
The Optical Coherence Tomography Drug Eluting Stent Investigation
Lead Sponsor:
Boston Scientific Corporation
Collaborating Sponsors:
Labcoat, Ltd.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 lesion...
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 ve...
Eligibility Criteria
Inclusion
- General Inclusion Criteria
- 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.
- Angiographic Inclusion Criteria
- 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.
Exclusion
- General Exclusion Criteria
- 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 contraindicated to ASA (successful prior desensitization to ASA is not an exclusion), clopidogrel, or ticlopidine
- 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)
- 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
- Patient that in the opinion of the investigator is not clinically appropriate for OCT evaluation.
- Angiographic Exclusion Criteria
- Evidence of thrombus of the study vessel, based on angiography or IVUS
- Study lesion is totally occluded (TIMI flow ≤ 1) either at baseline or before pre-dilatation
- Study lesion, or the study vessel proximal to the study lesion is moderately or severely calcified, by visual estimate
- Study lesion is ostial in location (within 3.0 mm of vessel origin)
- 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
- Study lesion involves a bifurcation with a diseased (\>50% stenotic) branch vessel \> 2.0 mm in diameter
- Left main coronary artery disease (stenosis \>50%) whether protected or unprotected
- Target lesion length \> 25 mm, based on visual estimate by operator
- Target vessel diameter \> 3.5 mm, based on visual estimate by operator
- Target vessel diameter \< 2.75 mm based on visual estimate by operator
- Pre-treatment of the target lesion (excluding predilation) with another interventional device.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00776204
Start Date
May 1 2008
End Date
February 1 2011
Last Update
March 1 2017
Active Locations (1)
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1
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24128