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A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS® ElementTM Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions


Phase 1
18 Years
80 Years
Not Enrolling
Both
Coronary Heart Disease

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Trial Information

A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS® ElementTM Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions


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 months recruitment period.

Paclitaxel is the active ingredient in Taxol®, a drug originally developed to treat cancer.
The addition of the paclitaxel coating to the stent could improve the performance of the
stent by preventing the re-narrowing of the treated coronary artery. This re-narrowing is
called restenosis. Restenosis can occur after balloon angioplasty or the placement of a
stent and is the result of too much cell growth at the treatment site in the coronary
artery.

The TAXUS Element stent is an investigational device. The term investigational means that
the stent is not currently approved for commercial use by the FDA or other regulatory
agencies worldwide. The TAXUS Express 2 stent is also a coronary stent made with the same
drug coating as the Element stent. It is approved for commercial use by the FDA and other
regulatory agencies worldwide, with the exception of the 4.0 mm size, which is not yet
approved by the FDA. However, the 4.0 mm size was studied for safety and performance in a
clinical trial and the results of that trial have been submitted to FDA to support approval.
FDA has agreed that the 4.0 mm size may be used in this trial.

Paclitaxel was selected as the drug to coat the stent because it is known to prevent the
uncontrolled cell growth that contributes to the narrowing of artery, by interfering with
the ability of cells to divide and multiply. Because of these properties, it has been used
as a drug for the treatment of various types of cancer. Cancer patients are given paclitaxel
as a solution into the vein. For this study, paclitaxel will be administered locally to the
wall of coronary artery as a coating on the stent. Cancer patients receive a dose of
paclitaxel approximately 1100 - 1400 times greater than the dose used in the coating of the
stent. It is highly unlikely that levels of paclitaxel in the blood would be measurable or
have effects anywhere beyond the heart.


Inclusion Criteria:



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 Criteria:

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)

Type of Study:

Interventional

Study Design:

N/A

Authority:

Singapore: Domain Specific Review Boards

Study ID:

Taxus Perseus

NCT ID:

NCT00693979

Start Date:

Completion Date:

Related Keywords:

  • Coronary Heart Disease
  • Coronary Artery Disease
  • Myocardial Ischemia
  • Coronary Disease
  • Heart Diseases

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