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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MINVASYS
ClinicalTrials.gov Identifier:
NCT01308229
First received: March 3, 2011
Last updated: November 8, 2013
Last verified: November 2013

March 3, 2011
November 8, 2013
December 2008
January 2011   (final data collection date for primary outcome measure)
Angiographic restenosis rate (%) [ Time Frame: 9 months post-procedure ] [ Designated as safety issue: No ]
Angiographic restenosis rate of the main branch and side branch by Quantitative Coronary Angiography (QCA).
Same as current
Complete list of historical versions of study NCT01308229 on ClinicalTrials.gov Archive Site
  • Clinically-driven Target Vessel Failure (TVF) [ Time Frame: 9 months post-procedure ] [ Designated as safety issue: Yes ]
  • Target Lesion Revascularization (TLR) [ Time Frame: 9 months after procedure ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization (TVR) [ Time Frame: 9 months post-procedure ] [ Designated as safety issue: Yes ]
  • Acute success (device, lesion, and procedure) [ Time Frame: at procedure ] [ Designated as safety issue: Yes ]
  • Angiographic in-stent Late Lumen Loss (LLL) [ Time Frame: 9 months post-procedure ] [ Designated as safety issue: No ]
  • Minimum luminal diameter (MLD) [ Time Frame: 9 months post-procedure ] [ Designated as safety issue: No ]
  • Angiographic parameters [ Time Frame: 9 months post-procedure ] [ Designated as safety issue: No ]
    Angiographic parameters (in-stent and in-segment) including percent Diameter Stenosis (%DS)
  • Major Adverse Cardiac Event (MACE) rate [ Time Frame: 30 days and 9 months post-procedure ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of the Nile PAX Drug-Eluting Coronary Bifurcation Stent
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Disease
Device: Nile PAX® paclitaxel-eluting coronary stent
Implantation of a Nile PAX bifurcation dedicated drug-eluting stent in coronary arteries to treat stenosis lesions
Experimental: Nile PAX®
Intervention: Device: Nile PAX® paclitaxel-eluting coronary stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
102
March 2015
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Bulgaria,   France,   Italy,   Netherlands,   Poland,   Spain
 
NCT01308229
MIN0803
Yes
MINVASYS
MINVASYS
Not Provided
Principal Investigator: Jean FAJADET, MD Clinique Pasteur, Toulouse
MINVASYS
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP