Coronary DiseaseBIPAXNCT01308229
Safety and Efficacy Study of the Nile PAX Drug-Eluting Coronary Bifurcation Stent
A study testing Nile PAX® paclitaxel-eluting coronary stent in people with Coronary Disease, run by MINVASYS at 10 sites in 7 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Nile PAX® paclitaxel-eluting coronary stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 10 sitesin 7 countries
- Study dates
- Dec 2008to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
France4 sites
Centre Cardiologique d'Evecquemont
Évecquemont, 78740
Clinique Saint Hilaire
Rouen, 76000
Centre Cardiologique du Nord
Saint-Denis, 93200
Clinique Pasteur
Toulouse, 31076
About this study
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
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.
Read the 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.
- Conditions
- Coronary Disease
- Being tested
- Nile PAX® paclitaxel-eluting coronary stent
- Keywords
- Bifurcation, Dedicated, Drug-eluting stent, Angioplasty, Coronary artery disease, Coronary artery stenosis
- Medical subject headings
- Coronary Disease, Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nile PAX® paclitaxel-eluting coronary stentDevice
Implantation of a Nile PAX bifurcation dedicated drug-eluting stent in coronary arteries to treat stenosis lesions
| Study group | Role | What they receive |
|---|---|---|
| Nile PAX® | Experimental | Not described Receives: Device: Nile PAX® paclitaxel-eluting coronary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic restenosis rate (%)
Angiographic restenosis rate of the main branch and side branch by Quantitative Coronary Angiography (QCA).
Measured: 9 months post-procedure
Secondary outcomes (8)
Clinically-driven Target Vessel Failure (TVF)
Measured: 9 months post-procedure
Target Lesion Revascularization (TLR)
Measured: 9 months after procedure
Target Vessel Revascularization (TVR)
Measured: 9 months post-procedure
Acute success (device, lesion, and procedure)
Measured: at procedure
Angiographic in-stent Late Lumen Loss (LLL)
Measured: 9 months post-procedure
Minimum luminal diameter (MLD)
Measured: 9 months post-procedure
Angiographic parameters
Angiographic parameters (in-stent and in-segment) including percent Diameter Stenosis (%DS)
Measured: 9 months post-procedure
Major Adverse Cardiac Event (MACE) rate
Measured: 30 days and 9 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startDec 2008
- Primary completionJan 2011
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- MINVASYS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean FAJADET, MD, Principal investigator, Clinique Pasteur Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308229
- Sponsor's protocol ID
- MIN0803
- Acronym
- BIPAX
- Status last verified
- Nov 2013
- First submitted
- 3 Mar 2011
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01308229
- Acronym / sponsor ID
- BIPAX / MIN0803
- Conditions
- Coronary Disease
- Keywords
- Bifurcation, Dedicated, Drug-eluting stent, Angioplasty, Coronary artery disease, Coronary artery stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- MINVASYSIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nile PAX® | Experimental | Device: Nile PAX® paclitaxel-eluting coronary stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nile PAX® paclitaxel-eluting coronary stentImplantation of a Nile PAX bifurcation dedicated drug-eluting stent in coronary arteries to treat stenosis lesions | Device | Nile PAX® |
Primary outcome
Angiographic restenosis rate (%)
Time frame: 9 months post-procedure
Angiographic restenosis rate of the main branch and side branch by Quantitative Coronary Angiography (QCA).
8 secondary outcomes
Clinically-driven Target Vessel Failure (TVF)
Time frame: 9 months post-procedure
Target Lesion Revascularization (TLR)
Time frame: 9 months after procedure
Target Vessel Revascularization (TVR)
Time frame: 9 months post-procedure
Acute success (device, lesion, and procedure)
Time frame: at procedure
Angiographic in-stent Late Lumen Loss (LLL)
Time frame: 9 months post-procedure
Minimum luminal diameter (MLD)
Time frame: 9 months post-procedure
Angiographic parameters
Time frame: 9 months post-procedure
Major Adverse Cardiac Event (MACE) rate
Time frame: 30 days and 9 months post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean FAJADET, MD principal investigator
Clinique Pasteur Toulouse
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nile PAX® paclitaxel-eluting coronary stent in people with Coronary Disease, run by MINVASYS at 10 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Brazil, Bulgaria, Italy, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angiographic restenosis rate (%) (time frame: 9 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.