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

Study Overview
=================
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.

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

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Device: Nile PAX® paclitaxel-eluting coronary stent


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bifurcation, Dedicated, Drug-eluting stent, Angioplasty, Coronary artery disease, Coronary artery stenosis