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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

DEBlue Stent vs Cypher Stent in the Treatment of Advanced Coronary Artery Disease

NCT00473772

Coronary Artery Disease

COMPLETED PHASE1/PHASE2

The DESyne BDS Plus RCT: A Randomized Clinical Trial to Assess the Elixir DESyne BDS Plus Drug Eluting Coronary Stent System for the Treatment of de Novo Native Coronary Artery Lesions

NCT05033964

Coronary Artery Disease

ACTIVE_NOT_RECRUITING PHASE2

Clinical Study to Evaluate the STENTYS Xposition S for Treatment of Unprotected Left Main Coronary Artery Disease

NCT02800837

Coronary Artery Disease (Left Main)

UNKNOWN

Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter

NCT03908450

Coronary Artery Disease

COMPLETED NA

Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries

NCT00148356

Coronary Disease Coronary Artery Disease Coronary Restenosis

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nile PAX®

Group Type EXPERIMENTAL

Nile PAX® paclitaxel-eluting coronary stent

Intervention Type DEVICE

Implantation of a Nile PAX bifurcation dedicated drug-eluting stent in coronary arteries to treat stenosis lesions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nile PAX® paclitaxel-eluting coronary stent

Implantation of a Nile PAX bifurcation dedicated drug-eluting stent in coronary arteries to treat stenosis lesions

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No