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Status:

UNKNOWN

A Prospective Evaluation in a Randomized Trial of TAXUS in the Treatment of De Novo Coronary Artey Lesions

Lead Sponsor:

National University Hospital, Singapore

Collaborating Sponsors:

Boston Scientific Corporation

Conditions:

Coronary Heart Disease

Eligibility:

All Genders

18-80 years

Phase:

PHASE1

Brief Summary

This study is to compare the safety and performance of two stents coated with the same drug (the TAXUS Element Paclitaxel-Eluting Coronary Stent System and the TAXUS Express2 Paclitaxel-Eluting Corona...

Detailed Description

Approximately 1264 subjects at a maximum of 100 clinical sites will be part of this study. This study will recruit approximately 30 subjects from NHC \& NUH (12 from NUH) over a period of 6 to 9 month...

Eligibility Criteria

Inclusion

  • Clinical Inclusion Criteria
  • Subject is ≥ 18 years old and ≤ 80 years old
  • Eligible for percutaneous coronary intervention (PCI)
  • Documented stable angina pectoris (Canadian Cardiovascular Society \[CCS\] Classification 1, 2, 3, or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia
  • Acceptable candidate for coronary artery bypass grafting (CABG)
  • Left ventricular ejection fraction (LVEF) is \> 30%
  • Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
  • Subject willing to comply with all specified follow-up evaluations
  • Angiographic Inclusion Criteria (visual estimate)
  • Target lesion located in native coronary artery
  • Target lesion must be de novo
  • Target lesion diameter stenosis \> 50%
  • Reference vessel diameter (RVD) \> 2.75mm to \< 4.0mm
  • Cumulative target lesion length \< 28 mm (area to be treated must be completely coverable by one study stent)
  • Target lesion is successfully pre-dilated. Subjects are enrolled after successful balloon catheter pre-dilation of the target lesion and assignment to treatment arm by IVRS.
  • One non-target lesion may be treated in a non-target vessel
  • Non-target lesion in non-target vessel must be treated with a commercially available TAXUS stent if use of drug-eluting stent required.
  • Treatment must be deemed a clinical angiographic success, without requiring use of unplanned additional stent(s).
  • Treatment must be completed prior to treatment of target lesion.

Exclusion

  • Clinical Exclusion Criteria
  • Contraindication to ASA, or to both clopidogrel and ticlopidine
  • Known hypersensitivity to paclitaxel
  • Known allergy to stainless steel
  • Known allergy to platinum
  • Previous treatment of the target vessel with any anti-restenotic drug-coated or drug-eluting coronary stent
  • Previous treatment of the target vessel with a bare metal stent (BMS) within 9 months of the index procedure
  • Previous treatment of any non-target vessel with any anti-restenotic drug-coated or drug-eluting coronary stent within 9 months of the index procedure
  • Previous treatment with intravascular brachytherapy in the target vessel
  • Planned PCI or CABG post-index procedure
  • Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon or transluminal extraction catheter immediately prior to stent placement
  • Myocardial infarction (MI) within 72 hours prior to the index procedure as defined per protocol definition (see Appendix A)
  • Cerebrovascular accident (CVA) within the past 6 months
  • Cardiogenic shock characterized by systolic pressure \< 80mm Hg and/or central filling pressure \> 20 mm 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 and a cardiac index \> 1.8 liters/minute/m2
  • Acute or chronic renal dysfunction (creatinine \> 2.0 mg/dl or 177 μmol/l)
  • Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure
  • Leukopenia (leukocyte count \< 3.5 x 109/liter)
  • Thrombocytopenia (platelet count \< 100,000/mm3)
  • Thrombocytosis (\> 750,000/mm3)
  • Active peptic ulcer or active gastrointestinal (GI) bleeding
  • Current treatment, or past treatment within 12 months of the index procedure, with paclitaxel or other chemotherapeutic agent(s)
  • Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9 months after the index procedure
  • Male or female with known intention to procreate within 9 months after the index procedure
  • Positive pregnancy test within 7 days before the index procedure, or lactating
  • Life expectancy of less than 24 months due to other medical conditions
  • Co-morbid condition(s) that could limit the subject's ability to comply with study follow-up requirements or impact the scientific integrity of the study
  • Currently participating in another investigational drug or device study
  • Angiographic Exclusion Criteria (visual estimate)
  • Target lesion in left main artery, whether protected or unprotected
  • Target lesion is a chronic total occlusion (TIMI flow \< 1)
  • Target lesion is restenotic
  • Target lesion is located in a saphenous vein graft or mammary artery graft
  • Target lesion is accessed via saphenous vein graft or mammary artery graft
  • Target lesion is \< 5mm from bare metal stent (BMS)
  • Target lesion is \< 5mm from ostium
  • Target lesion is \< 5 mm from a side branch vessel ≥ 1.5 mm in diameter
  • Untreated lesions with ≥ 50% diameter stenosis or thought to impair flow remaining in target vessel
  • Target lesion and/or target vessel proximal to the target lesion is moderately or severely calcified
  • Target lesion and/or target vessel proximal to the target lesion is severely tortuous
  • Target lesion is located within or distal to a \> 60° bend in the vessel
  • Target lesion with angiographic presence of probable or definite thrombus
  • Unprotected left main coronary artery disease
  • Protected left main coronary artery disease with target lesion in LAD or LCx(subject may be enrolled if only lesion is target lesion in RCA)

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00693979

Last Update

June 9 2008

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