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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01308229
Recruitment Status : Completed
First Posted : March 4, 2011
Last Update Posted : April 8, 2015
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Coronary Disease Device: Nile PAX® paclitaxel-eluting coronary stent Not Applicable

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  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : March 2015

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

Primary Outcome Measures :
  1. Angiographic restenosis rate (%) [ Time Frame: 9 months post-procedure ]
    Angiographic restenosis rate of the main branch and side branch by Quantitative Coronary Angiography (QCA).

Secondary Outcome Measures :
  1. Clinically-driven Target Vessel Failure (TVF) [ Time Frame: 9 months post-procedure ]
  2. Target Lesion Revascularization (TLR) [ Time Frame: 9 months after procedure ]
  3. Target Vessel Revascularization (TVR) [ Time Frame: 9 months post-procedure ]
  4. Acute success (device, lesion, and procedure) [ Time Frame: at procedure ]
  5. Angiographic in-stent Late Lumen Loss (LLL) [ Time Frame: 9 months post-procedure ]
  6. Minimum luminal diameter (MLD) [ Time Frame: 9 months post-procedure ]
  7. Angiographic parameters [ Time Frame: 9 months post-procedure ]
    Angiographic parameters (in-stent and in-segment) including percent Diameter Stenosis (%DS)

  8. Major Adverse Cardiac Event (MACE) rate [ Time Frame: 30 days and 9 months post-procedure ]

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01308229

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

Responsible Party: MINVASYS Identifier: NCT01308229     History of Changes
Other Study ID Numbers: MIN0803
First Posted: March 4, 2011    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: November 2013

Keywords provided by MINVASYS:
Drug-eluting stent
Coronary artery disease
Coronary artery stenosis

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases