Clinical trial NCT01308229: Safety and Efficacy Study of the Nile PAX Drug-Eluting Coronary Bifurcation Stent
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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Keywords: Bifurcation
Dedicated
Drug-eluting stent
Angioplasty
Coronary artery disease
Coronary artery stenosis
Lead sponsor: MINVASYS
Sponsor class: INDUSTRY
First posted: 2011-03-04
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Angiographic restenosis rate (%)
timeFrame: 9 months post-procedure
Secondary outcomes:
measure: Clinically-driven Target Vessel Failure (TVF)
timeFrame: 9 months post-procedure
measure: Target Lesion Revascularization (TLR)
timeFrame: 9 months after procedure
measure: Target Vessel Revascularization (TVR)
timeFrame: 9 months post-procedure
measure: Acute success (device, lesion, and procedure)
timeFrame: at procedure
measure: Angiographic in-stent Late Lumen Loss (LLL)
timeFrame: 9 months post-procedure
measure: Minimum luminal diameter (MLD)
timeFrame: 9 months post-procedure
measure: Angiographic parameters
timeFrame: 9 months post-procedure
measure: Major Adverse Cardiac Event (MACE) rate
timeFrame: 30 days and 9 months post-procedure
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
city: Sofia
country: Bulgaria
facility: Tokuda Hospital
city: Evecquemont
country: France
facility: Centre Cardiologique d'Evecquemont
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Saint Denis
country: France
facility: Centre Cardiologique du Nord
city: Toulouse
country: France
facility: Clinique Pasteur
city: Mercogliano
country: Italy
facility: Casa di Cura Montevergine
city: Rotterdam
country: Netherlands
facility: Thorax Centre
city: Poznań
country: Poland
facility: Karol Marcinkowski University of Medical Sciences
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D´Hebron
Study officials:
affiliation: Clinique Pasteur Toulouse
name: Jean FAJADET, MD
role: PRINCIPAL_INVESTIGATOR
References: