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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: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Coronary Disease
 Device: Nile PAX® paclitaxel-eluting coronary stent

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by MINVASYS:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 102
Study Start Date: December 2008
Estimated Study Completion Date: March 2015
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308229

Locations
Brazil
Instituto Dante Pazzanese de Cardiologia
Sao Paulo, Brazil, 01412180
Bulgaria
Tokuda Hospital
Sofia, Bulgaria, 1407
France
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
Italy
Casa di Cura Montevergine
Mercogliano, Italy, 83013
Netherlands
Thorax Centre
Rotterdam, Netherlands, 300DR
Poland
Karol Marcinkowski University of Medical Sciences
Poznań, Poland, 61-848
Spain
Hospital Universitari Vall D´Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
MINVASYS
Investigators
Principal Investigator: Jean FAJADET, MD Clinique Pasteur - Toulouse
  More Information

No publications provided

Responsible Party: MINVASYS
ClinicalTrials.gov Identifier: NCT01308229     History of Changes
Other Study ID Numbers: MIN0803
Study First Received: March 3, 2011
Last Updated: July 31, 2012
Health Authority: France: Agence française de sécurité sanitaire des produits de santé (AFSSAPS)
Italy: Ministero della salute
Spain: Agencia espanola de medicamentos y productos sanitarios
Bulgaria: Local Ethics Board - Tokuda Hospital Sofia
The Netherlands: Medische Etische Toetsings Commissie - Erasmus MC
Poland: Urzedu Rejestracji produktow leczniczych, wyrobow medycznych i produktow biobojczych
Brazil: Agencia nacional de vigilancia sanitaria

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

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Paclitaxel
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013