A Randomized, Double-Blind, Controlled Study of the Safety and Performance of the NIRx™ Paclitaxel-Coated Conformer Coronary Stent
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The clinical investigation is an international, prospective, double-blind, randomized safety and efficacy study. The purpose of this study is to evaluate the safety and performance of the NIRx(TM) Paclitaxel-Coated Stent (1.0µg/mm2 of paclitaxel incorporated into slow- and moderate-release formulation of a triblock copolymer carrier system)in patients who present for stenting of de novo lesions of a native coronary artery.
Condition or disease
Coronary Artery Disease
Device: NIRx(TM) Paclitaxel-Coated Conformer Coronary Stent System
The primary objective of this study is to evaluate the safety and performance of coronary artery stenting with the NIRx(TM) Paclitaxel-Coated Stent (1.0µg/mm2 of paclitaxel incorporated into slow- and moderate-release formulation of a triblock copolymer carrier system) for the treatment of de novo lesions in native vessels. Patients in 2 sequential cohorts will be randomised to receive either the NIRx(TM) Paclitaxel-Coated Stent or the uncoated control stent. In cohort 1, the slow-release formulation NIRx(TM) Paclitaxel-Coated Stent will be studied. If the safety profile is acceptable, the moderate-release formulation NIRx(TM) Paclitaxel-Coated Stent will be studied in Cohort 2. In each f the 2 cohorts, 133 patients will be treated with the NIRx(TM) paclitaxel-Coated Stent and 133 with the uncoated control stent (1.1 ratio), for a total of 532 patients in study.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
General Inclusion Criteria:
Patient >= 18 years old.
Eligible for percutaneous transluminal coronary angioplasty (PTCA).
Patient (or legal guardian) understands the study requirements and the stent treatment procedure and provides written Informed Consent before any study-specific tests or procedures are performed.
Willing to comply with all specified follow-up evaluations.
Documented stable angina pectoris (Canadian Cardiovascular Society Classification [CCS] 1, 2, 3, or 4), unstable angina pectoris with documented ischemia (Braunwald Class IB - C, IIB - C, or IIIB - C), or documented silent ischemia.
Acceptable candidate for CABG.
Angiographic Inclusion Criteria:
Target lesion is located within a native coronary vessel.
Target lesion is de novo (i.e., a coronary lesion not previously treated).
Target lesion diameter stenosis >= 50% and <= 99% (visual estimate or on-line QCA).
Target lesion <= 12 mm in length (visual estimate or on-line QCA).
Target vessel >= 3.0 mm and <= 3.5 mm in diameter (visual estimate or on-line QCA).
General Exclusion Criteria:
Known sensitivity to paclitaxel.
Patient has received paclitaxel or other anti-mitogenic agent within 12 months prior to planned enrollment in the study.
Patient has previous stent procedure with any drug-coated or drug-eluting stent device.
Patient has undergone any coronary intervention within 30 days prior to stent placement associated with this protocol.
Patient anticipates planned additional intervention (staged procedure) to any non-target coronary vessel within 45 days after the stent placement associated with this protocol.
MI within 72 hours of planned stent placement.
Left ventricular ejection fraction (LVEF) of < 30%.
Stroke within the past 6 months.
Acute or chronic renal dysfunction (creatinine >1.7 mg/mL or >150 µmol/L).
Acetylsalicylic acid and/or clopidogrel and/or ticlopidine are contraindicated.
Leukopenia (leukocytes <3.5 x 109/liter).
Thrombocytopenia (platelets <100,000/mm3).
Active peptic ulcer or active gastrointestinal (GI) bleeding.
Known allergy to stainless steel.
Previously enrolled in the NIRx(TM) Coronary Stent Clinical Safety and Performance Study.
Currently enrolled in another investigational device or drug study and has not completed the required follow-up period, or has completed all other study-required follow-up less than 30 days prior to enrollment in this study.
Patient is lactating, has a positive pregnancy test within 7 days of planned stent placement, or intends to become pregnant during the study (only applies to female patients of child-bearing potential).
Life expectancy of less than 24 months because of other medical conditions.
Co-morbid condition(s) that could limit the patient's ability to participate in the study or comply with follow-up requirements or co-morbid condition(s) that could impact the scientific integrity of the study.
Angiographic Exclusion Criteria:
Unprotected left main coronary artery disease (or obstruction greater than 50% in the left main coronary artery that is not protected by at least 1 non-obstructed bypass graft to the left anterior descending [LAD] or circumflex artery or a branch thereof).
Target lesion is in a previously stented segment.
Target vessel was treated with directional coronary atherectomy, laser, or transluminal extraction catheter prior to stent placement.
Target lesion is ostial in location (within 3 mm of vessel origin).
Target site of stent placement has side branches >2.0 mm in diameter.
Target lesion is severely calcified (by visual estimate)
Target vessel has closed abruptly or is threatening closure.
Target lesion is located within or immediately distal to a >60° bend in the vessel.
Target vessel has diffuse disease requiring more than one 15 mm stent for full lesion coverage.
Target lesion involves a bifurcation where a branch vessel greater than 2.0 mm in diameter originates (either stenosis of both main vessel and major branch or stenosis of just major branch).
Target lesion has excessive tortuosity unsuitable for stent delivery and deployment.
Target lesion is located within a saphenous vein bypass graft.
Target lesion is located in a vessel section supplied by distal graft.