NCT00299026

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
532

participants targeted

Target at P75+ for phase_2 coronary-artery-disease

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_2 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

1.9 years

First QC Date

March 3, 2006

Last Update Submit

March 1, 2017

Conditions

Coronary Artery Disease

Keywords

Coronary Artery DiseasePercutaneous Coronary InterventionStent ImplantDrug-coated Stent

Outcome Measures

Primary Outcomes (1)

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

Interventions

NIRx(TM) Paclitaxel-Coated Conformer Coronary Stent SystemDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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).

You may not qualify if:

  • 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.
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Raffaele del Monte Tabor

Milan, 20132, Italy

Location

Related Publications (1)

  • Silber S, Colombo A, Banning AP, Hauptmann K, Drzewiecki J, Grube E, Dudek D, Baim DS. Final 5-year results of the TAXUS II trial: a randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for de novo coronary artery lesions. Circulation. 2009 Oct 13;120(15):1498-504. doi: 10.1161/CIRCULATIONAHA.109.849877. Epub 2009 Sep 28.

    PMID: 19786634DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Antonio Colombo, MD

    Ospedale San Raffaele del Monte Tabor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 3, 2006

First Posted

March 6, 2006

Study Start

June 1, 2001

Primary Completion

May 1, 2003

Study Completion

February 1, 2007

Last Updated

March 3, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)