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Safety and Efficacy Study of the Nile PAX Drug-Eluting Coronary Bifurcation Stent (BIPAX)

Primary Purpose

Coronary Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Nile PAX® paclitaxel-eluting coronary stent
Sponsored by
MINVASYS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Bifurcation, Dedicated, Drug-eluting stent, Angioplasty, Coronary artery disease, Coronary artery stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Instituto Dante Pazzanese de Cardiologia
  • Tokuda Hospital
  • Centre Cardiologique d'Evecquemont
  • Clinique Saint Hilaire
  • Centre Cardiologique du Nord
  • Clinique Pasteur
  • Casa di Cura Montevergine
  • Thorax Centre
  • Karol Marcinkowski University of Medical Sciences
  • Hospital Universitari Vall D´Hebron

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nile PAX®

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinically-driven Target Vessel Failure (TVF)
Target Lesion Revascularization (TLR)
Target Vessel Revascularization (TVR)
Acute success (device, lesion, and procedure)
Angiographic in-stent Late Lumen Loss (LLL)
Minimum luminal diameter (MLD)
Angiographic parameters
Angiographic parameters (in-stent and in-segment) including percent Diameter Stenosis (%DS)
Major Adverse Cardiac Event (MACE) rate

Full Information

First Posted
March 3, 2011
Last Updated
April 7, 2015
Sponsor
MINVASYS
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1. Study Identification

Unique Protocol Identification Number
NCT01308229
Brief Title
Safety and Efficacy Study of the Nile PAX Drug-Eluting Coronary Bifurcation Stent
Acronym
BIPAX
Official Title
Assessment of 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MINVASYS

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The BIPAX clinical trial is a prospective, non-randomized, multicenter, clinical trial evaluating the investigational coronary bifurcation device Nile PAX® in patients with main branch reference vessel diameters >= 2.5 mm and <= 3.5 mm, side branch reference vessel diameters >= 2.0 and <= 3.0 and lesion length <= 14 mm. The trial allows the treatment of a single de novo bifurcation lesion in native coronary arteries following the provisional T-stenting technique with mandatory pre-dilatation of the main branch. In case the side branch requires a stent the treatment will be completed when possible with a Delta PAX® Drug Eluting Side Branch Stent. The BIPAX clinical trial will enroll 100 patients. All patients will receive Quantitative Coronary Angiography (QCA) after stent implantation and at 9 months follow-up. All patients will have a clinical follow-up at 1, 6, 9 and 12 months and subsequently every year up to 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Bifurcation, Dedicated, Drug-eluting stent, Angioplasty, Coronary artery disease, Coronary artery stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nile PAX®
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Nile PAX® paclitaxel-eluting coronary stent
Intervention Description
Implantation of a Nile PAX bifurcation dedicated drug-eluting stent in coronary arteries to treat stenosis lesions
Primary Outcome Measure Information:
Title
Angiographic restenosis rate (%)
Description
Angiographic restenosis rate of the main branch and side branch by Quantitative Coronary Angiography (QCA).
Time Frame
9 months post-procedure
Secondary Outcome Measure Information:
Title
Clinically-driven Target Vessel Failure (TVF)
Time Frame
9 months post-procedure
Title
Target Lesion Revascularization (TLR)
Time Frame
9 months after procedure
Title
Target Vessel Revascularization (TVR)
Time Frame
9 months post-procedure
Title
Acute success (device, lesion, and procedure)
Time Frame
at procedure
Title
Angiographic in-stent Late Lumen Loss (LLL)
Time Frame
9 months post-procedure
Title
Minimum luminal diameter (MLD)
Time Frame
9 months post-procedure
Title
Angiographic parameters
Description
Angiographic parameters (in-stent and in-segment) including percent Diameter Stenosis (%DS)
Time Frame
9 months post-procedure
Title
Major Adverse Cardiac Event (MACE) rate
Time Frame
30 days and 9 months post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean FAJADET, MD
Organizational Affiliation
Clinique Pasteur Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
Sao Paulo
ZIP/Postal Code
01412180
Country
Brazil
Facility Name
Tokuda Hospital
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Centre Cardiologique d'Evecquemont
City
Evecquemont
ZIP/Postal Code
78740
Country
France
Facility Name
Clinique Saint Hilaire
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Centre Cardiologique du Nord
City
Saint Denis
ZIP/Postal Code
93200
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Casa di Cura Montevergine
City
Mercogliano
ZIP/Postal Code
83013
Country
Italy
Facility Name
Thorax Centre
City
Rotterdam
ZIP/Postal Code
300DR
Country
Netherlands
Facility Name
Karol Marcinkowski University of Medical Sciences
City
Poznań
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Hospital Universitari Vall D´Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

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Safety and Efficacy Study of the Nile PAX Drug-Eluting Coronary Bifurcation Stent

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