Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Percutaneous Coronary Intervention, Stent Implant, Drug-coated Stent
Brief summary
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.
Detailed description
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.
Interventions
DEVICENIRx(TM) Paclitaxel-Coated Conformer Coronary Stent System
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percent in-stent net volume obstruction at 6 months post-procedure as measured by IVUS | — |
Countries
Italy
Outcome results
None listed