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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Disease
• Intervention / Treatment: Device: Nile PAX® paclitaxel-eluting coronary stent

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 01412180
    • Instituto Dante Pazzanese de Cardiologia
• Bulgaria
  • Sofia, Bulgaria, 1407
    • Tokuda Hospital
• France
  • Evecquemont, France, 78740
    • Centre Cardiologique d'Evecquemont
  • Rouen, France, 76000
    • Clinique Saint Hilaire
  • Saint Denis, France, 93200
    • Centre Cardiologique du Nord
  • Toulouse, France, 31076
    • Clinique Pasteur
• Italy
  • Mercogliano, Italy, 83013
    • Casa di Cura Montevergine
• Netherlands
  • Rotterdam, Netherlands, 300DR
    • Thorax Centre
• Poland
  • Poznań, Poland, 61-848
    • Karol Marcinkowski University of Medical Sciences
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d´Hebron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nile PAX®	Device: Nile PAX® paclitaxel-eluting coronary stent; Implantation of a Nile PAX bifurcation dedicated drug-eluting stent in coronary arteries to treat stenosis lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiographic restenosis rate (%)	Angiographic restenosis rate of the main branch and side branch by Quantitative Coronary Angiography (QCA).	9 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Minimum luminal diameter (MLD)		9 months post-procedure
Angiographic parameters	Angiographic parameters (in-stent and in-segment) including percent Diameter Stenosis (%DS)	9 months post-procedure
Major Adverse Cardiac Event (MACE) rate		30 days and 9 months post-procedure

Collaborators and Investigators

• Sponsor: MINVASYS
• Investigators: Principal Investigator: Jean FAJADET, MD, Clinique Pasteur Toulouse

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: March 3, 2011
• First Submitted That Met QC Criteria: March 3, 2011
• First Posted (Estimate): March 4, 2011

Study Record Updates

• Last Update Posted (Estimate): April 8, 2015
• Last Update Submitted That Met QC Criteria: April 7, 2015
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Coronary artery disease; Bifurcation; Angioplasty; Drug-eluting stent; Coronary artery stenosis; Dedicated
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: MIN0803