Clinicals
Trial
Trial Cardiology
BIPAX Clinical Trial - Trial ID: MIN0803
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.
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.
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.
Angiographic restenosis rate at 9 months post-procedure of the main branch and side branch by Quantitative Coronary Angiography (QCA).
Clinically-driven Target Vessel Failure (TVF), Target Lesion Revascularization (TLR) and Target Vessel Revascularization (TVR) at 9 months post-procedure.
Acute success (device, lesion, and procedure).
Angiographic in-stent Late Lumen Loss (LLL) at 9 months post-procedure.
Minimum luminal diameter (MLD) at 9 months post-procedure.
Angiographic parameters (in-stent and in-segment) including percent Diameter Stenosis (%DS) at 9 months post-procedure.
Major Adverse Cardiac Event (MACE) rate at 30 days and 9 months post-procedure.
Doctor Jean FAJADET
Unité de Cardiologie Interventionnelle
Clinique PASTEUR
43-45 avenue de Lombez
31076 Toulouse Cedex3
France
Unité de Cardiologie Interventionnelle
Clinique PASTEUR
43-45 avenue de Lombez
31076 Toulouse Cedex3
France
1. De novo bifurcation lesions following the Medina classification except (0,0,1).
2. Reference diameter main branch sup.equ 2.5 and inf.equ 3.5 mm and side branch sup.equ 2.0 and inf.equ 3.0 mm.
3. Main branch lesion length inf.equ 14 mm and side branch lesion inf.equ 5 mm. Main branch lesion length inf.equ 7 mm proximal and distal to the carina.
4. Maximum one bifurcation lesion per patient.
5. Single bifurcation lesion per vessel.
6. Treatment of a lesion in a vessel - other than the bifurcation lesion target vessel
2. Reference diameter main branch sup.equ 2.5 and inf.equ 3.5 mm and side branch sup.equ 2.0 and inf.equ 3.0 mm.
3. Main branch lesion length inf.equ 14 mm and side branch lesion inf.equ 5 mm. Main branch lesion length inf.equ 7 mm proximal and distal to the carina.
4. Maximum one bifurcation lesion per patient.
5. Single bifurcation lesion per vessel.
6. Treatment of a lesion in a vessel - other than the bifurcation lesion target vessel
1. De novo bifurcation lesion Medina (0,0,1).
2. Left main bifurcation.
3. Main branch lesion length > 14 mm and side branch lesion > 5 mm. Main branch lesion length > 7 mm proximal or distal to the carina.
4. The stent covers beyond the lesion proximally and distally with < 2 mm (visual).
5. Heavily calcified lesions (visual estimation).
6. Severe tortuous lesions.
7. Women of childbearing potential.
8. Documented left ventricular ejection fraction (LVEF) < 30% at most recent evaluation.
9. Side branch stented with other device than Delta PAX®.
10. Target lesion further treated with a device other than the trial devices (Nile PAX® and Delta PAX®).
11. A known hypersensitivity or contraindication to aspirin, heparin or bivaluridin, ticlopidine or clopidogrel, cobalt chromium alloys, contrast media, which cannot be adequately pre-medicated.
12. History of an allergic reaction or significant sensitivity to paclitaxel or drugs in similar class.
13. Chronic total occlusion (CTO).
14. A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
15. Evidence of an acute MI within 72 hours of the intended index procedure (defined as: Q wave myocardial infarction (QWMI) or non-Q wave myocardial infarction (NQWMI) having CK enzymes > 2X the upper laboratory normal with the presence of a CK-MB elevated above the Institution
2. Left main bifurcation.
3. Main branch lesion length > 14 mm and side branch lesion > 5 mm. Main branch lesion length > 7 mm proximal or distal to the carina.
4. The stent covers beyond the lesion proximally and distally with < 2 mm (visual).
5. Heavily calcified lesions (visual estimation).
6. Severe tortuous lesions.
7. Women of childbearing potential.
8. Documented left ventricular ejection fraction (LVEF) < 30% at most recent evaluation.
9. Side branch stented with other device than Delta PAX®.
10. Target lesion further treated with a device other than the trial devices (Nile PAX® and Delta PAX®).
11. A known hypersensitivity or contraindication to aspirin, heparin or bivaluridin, ticlopidine or clopidogrel, cobalt chromium alloys, contrast media, which cannot be adequately pre-medicated.
12. History of an allergic reaction or significant sensitivity to paclitaxel or drugs in similar class.
13. Chronic total occlusion (CTO).
14. A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
15. Evidence of an acute MI within 72 hours of the intended index procedure (defined as: Q wave myocardial infarction (QWMI) or non-Q wave myocardial infarction (NQWMI) having CK enzymes > 2X the upper laboratory normal with the presence of a CK-MB elevated above the Institution
On going trial.
QCA follow-up at 9 months post-procedure.
Clinical follow-up at 1, 6 and 9 months, and at 1, 2, 3, 4 and 5 years.
Clinical follow-up at 1, 6 and 9 months, and at 1, 2, 3, 4 and 5 years.
