Status:
COMPLETED
A Randomized, Double-Blind, Controlled Study of the Safety and Performance of the NIRx™ Paclitaxel-Coated Conformer Coronary Stent
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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) Pac...
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...
Eligibility Criteria
Inclusion
- General
- 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
- 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
- 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
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
532 Patients enrolled
Trial Details
Trial ID
NCT00299026
Start Date
June 1 2001
End Date
February 1 2007
Last Update
March 3 2017
Active Locations (1)
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1
San Raffaele del Monte Tabor
Milan, Italy, 20132