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

Coronary Disease Clinical Trial

— BIPAX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308229
• Other study ID #: MIN0803
• Status: Completed
• Phase: N/A
• First received: March 3, 2011
• Last updated: April 7, 2015
• Start date: December 2008
• Est. completion date: March 2015

Study information

• Verified date: November 2013
• Source: MINVASYS
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence française de sécurité sanitaire des produits de santé (AFSSAPS)Italy: Ministero della saluteSpain: Agencia espanola de medicamentos y productos sanitariosBulgaria: Local Ethics Board - Tokuda Hospital SofiaThe Netherlands: Medische Etische Toetsings Commissie - Erasmus MCPoland: Urzedu Rejestracji produktow leczniczych, wyrobow medycznych i produktow biobojczychBrazil: Agencia nacional de vigilancia sanitaria
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 2015
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Device:
• Nile PAX® paclitaxel-eluting coronary stent
Implantation of a Nile PAX bifurcation dedicated drug-eluting stent in coronary arteries to treat stenosis lesions

Locations

Country	Name	City	State
Brazil	Instituto Dante Pazzanese de Cardiologia	Sao Paulo
Bulgaria	Tokuda Hospital	Sofia
France	Centre Cardiologique d'Evecquemont	Evecquemont
France	Clinique Saint Hilaire	Rouen
France	Centre Cardiologique du Nord	Saint Denis
France	Clinique Pasteur	Toulouse
Italy	Casa di Cura Montevergine	Mercogliano
Netherlands	Thorax Centre	Rotterdam
Poland	Karol Marcinkowski University of Medical Sciences	Poznan
Spain	Hospital Universitari Vall D´Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
MINVASYS

Countries where clinical trial is conducted

Brazil,  Bulgaria,  France,  Italy,  Netherlands,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic restenosis rate (%)	Angiographic restenosis rate of the main branch and side branch by Quantitative Coronary Angiography (QCA).	9 months post-procedure	No
Secondary	Clinically-driven Target Vessel Failure (TVF)		9 months post-procedure	Yes
Secondary	Target Lesion Revascularization (TLR)		9 months after procedure	Yes
Secondary	Target Vessel Revascularization (TVR)		9 months post-procedure	Yes
Secondary	Acute success (device, lesion, and procedure)		at procedure	Yes
Secondary	Angiographic in-stent Late Lumen Loss (LLL)		9 months post-procedure	No
Secondary	Minimum luminal diameter (MLD)		9 months post-procedure	No
Secondary	Angiographic parameters	Angiographic parameters (in-stent and in-segment) including percent Diameter Stenosis (%DS)	9 months post-procedure	No
Secondary	Major Adverse Cardiac Event (MACE) rate		30 days and 9 months post-procedure	Yes