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A Randomized, Double-Blind, Controlled Study of the Safety and Performance of the NIRx™ Paclitaxel-Coated Conformer Coronary Stent

This study has been completed.
Information provided by:
Boston Scientific Corporation Identifier:
First received: March 3, 2006
Last updated: March 1, 2017
Last verified: March 2017
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 Intervention Phase
Coronary Artery Disease
Device: NIRx(TM) Paclitaxel-Coated Conformer Coronary Stent System
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Treatment
Official Title: TAXUS II: A Randomized, Double-Blind, Controlled Study of the Safety and Performance of the NIRx™ Paclitaxel-Coated Conformer Coronary Stent

Resource links provided by NLM:

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Mean percent in-stent net volume obstruction at 6 months post-procedure as measured by IVUS

Estimated Enrollment: 532
Study Start Date: June 2001
Study Completion Date: February 2007
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00299026

San Raffaele del Monte Tabor
Milano, Italy, 20132
Sponsors and Collaborators
Boston Scientific Corporation
Principal Investigator: Antonio Colombo, MD Ospedale San Raffaele del Monte Tabor
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Thomas Naeschen, PhD, Boston Scientific Identifier: NCT00299026     History of Changes
Other Study ID Numbers: TAXUS II
Study First Received: March 3, 2006
Last Updated: March 1, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston Scientific Corporation:
Coronary Artery Disease
Percutaneous Coronary Intervention
Stent Implant
Drug-coated Stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017