NCT01308229

Brief Summary

The purpose of this trial is to assess the safety and efficacy of the Nile PAX® Drug Eluting Coronary Bifurcation Stent System for the treatment of single de novo bifurcation lesions in native coronary arteries with a main branch reference vessel diameter of 2.5-3.5 mm and side branch reference vessel diameter of 2.0-3.0 mm.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable

Geographic Reach
7 countries

10 active sites

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

December 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2011

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 8, 2015

Status Verified

November 1, 2013

Enrollment Period

2.1 years

First QC Date

March 3, 2011

Last Update Submit

April 7, 2015

Conditions

Coronary Disease

Keywords

BifurcationDedicatedDrug-eluting stentAngioplastyCoronary artery diseaseCoronary artery stenosis

Outcome Measures

Primary Outcomes (1)

  • Angiographic restenosis rate (%)

    Angiographic restenosis rate of the main branch and side branch by Quantitative Coronary Angiography (QCA).

    9 months post-procedure

Secondary Outcomes (8)

  • Clinically-driven Target Vessel Failure (TVF)

    9 months post-procedure

  • Target Lesion Revascularization (TLR)

    9 months after procedure

  • Target Vessel Revascularization (TVR)

    9 months post-procedure

  • Acute success (device, lesion, and procedure)

    at procedure

  • Angiographic in-stent Late Lumen Loss (LLL)

    9 months post-procedure

  • +3 more secondary outcomes

Study Arms (1)

Nile PAX®

EXPERIMENTAL
Device: Nile PAX® paclitaxel-eluting coronary stent

Interventions

Nile PAX® paclitaxel-eluting coronary stentDEVICE

Implantation of a Nile PAX bifurcation dedicated drug-eluting stent in coronary arteries to treat stenosis lesions

Nile PAX®

Eligibility Criteria

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

You may qualify if:

  • De novo bifurcation lesions following the Medina classification except (0,0,1).
  • Maximum one bifurcation lesion per patient.
  • Single bifurcation lesion per vessel.
  • The patient is at least 18 years of age. The patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional trial.
  • The patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergent coronary artery bypass graft (CABG) surgery.
  • The patient or patient's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical site.
  • The patient agrees to return to the same research facility for all required post-procedure follow-up visits.

You may not qualify if:

  • De novo bifurcation lesion Medina (0,0,1).
  • Left main bifurcation.
  • Heavily calcified lesions.
  • Severe tortuous lesions.
  • Documented left ventricular ejection fraction (LVEF) \< 30% at most recent evaluation.
  • Women of childbearing potential.
  • Chronic total occlusion (CTO).
  • Previous PCI of the target lesion.
  • Second lesion requiring treatment in target vessel.
  • Second bifurcation lesion requiring treatment.
  • Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Instituto Dante Pazzanese de Cardiologia

São Paulo, 01412180, Brazil

Location

Tokuda Hospital

Sofia, 1407, Bulgaria

Location

Centre Cardiologique d'Evecquemont

Évecquemont, 78740, France

Location

Clinique Saint Hilaire

Rouen, 76000, France

Location

Centre Cardiologique du Nord

Saint-Denis, 93200, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Casa di Cura Montevergine

Mercogliano, 83013, Italy

Location

Thorax Centre

Rotterdam, 300DR, Netherlands

Location

Karol Marcinkowski University of Medical Sciences

Poznan, 61-848, Poland

Location

Hospital Universitari Vall D´Hebron

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Coronary DiseaseCoronary Artery DiseaseCoronary Stenosis

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Jean FAJADET, MD

    Clinique Pasteur Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2011

First Posted

March 4, 2011

Study Start

December 1, 2008

Primary Completion

January 1, 2011

Study Completion

March 1, 2015

Last Updated

April 8, 2015

Record last verified: 2013-11

Locations

BU(1)IT(1)FR(4)NL(1)BR(1)PL(1)ES(1)