PAX B Clinical Trial - Trial ID: MIN0802
The purpose of this trial is to assess the safety and efficacy of the Amazonia PAX® Drug Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries with a reference vessel diameter of 2.5-3.5 mm.
The PAX B clinical trial is a prospective, non-randomized, multicenter, European clinical trial evaluating the investigational device Amazonia PAX® in patients with reference vessel diameters (RVD) sup.equ 2.5 mm and inf.equ 3.5 mm and lesion lengths inf.equ 20 mm. The trial allows the treatment of single, de novo lesions in native coronary arteries. Stents should cover beyond the lesion proximally and distally with 3 mm (visual appreciation).
The PAX B clinical trial will enroll 100 patients. Quantitative Coronary Angiography (QCA) measurements will be made after stent implantation, and repeated at 9 months follow-up.
The PAX B clinical trial is a prospective, non-randomized, multicenter, European clinical trial evaluating the investigational device Amazonia PAX® in patients with reference vessel diameters (RVD) sup.equ 2.5 mm and inf.equ 3.5 mm and lesion lengths inf.equ 20 mm. The trial allows the treatment of single, de novo lesions in native coronary arteries. Stents should cover beyond the lesion proximally and distally with 3 mm (visual appreciation).
The PAX B clinical trial will enroll 100 patients. Quantitative Coronary Angiography (QCA) measurements will be made after stent implantation, and repeated at 9 months follow-up.
1. Angiographic in-stent Late Lumen Loss (LLL) at 9 months post-procedure.
1. Clinically-driven Target Vessel Failure (TVF), Target Lesion Revascularization (TLR) and Target Vessel Revascularization (TVR) at 9 months post-procedure.
2. Acute success (device, lesion, and procedure).
3. Angiographic Binary Restenosis (ABR) rate and Minimum Luminal Diameter (MLD) at 9 months post-procedure.
4. Angiographic parameters (in-stent and in-segment) including percent Diameter Stenosis (%DS) at 9 months post-procedure.
5. Major Adverse Cardiac Event (MACE) rate at 30 days, 6 and 9 months post-procedure.
2. Acute success (device, lesion, and procedure).
3. Angiographic Binary Restenosis (ABR) rate and Minimum Luminal Diameter (MLD) at 9 months post-procedure.
4. Angiographic parameters (in-stent and in-segment) including percent Diameter Stenosis (%DS) at 9 months post-procedure.
5. Major Adverse Cardiac Event (MACE) rate at 30 days, 6 and 9 months post-procedure.
Alexandre Abizaid, MD, PhD
Instituto Dante Pazzanese de Cardiologia
São Paulo, SP
Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, SP
Brazil
Brazil
Doctor Alexander ABIZAID
Instituto Dante Pazzanese de Cardiologia
Doctor Breno Oliveira Almeida
Hospital Santa Marcelina
Doctor Marco Antonio Perin
Hospital Israelita Albert Einstein
France
Docteur Hakim Benamer (Coordinateur national)
Hopital Européen de Paris – La Roseraie
Docteur Jacques Berland
Docteur René Koning
Clinique Saint Hilaire
Doctor Thierry Royer
Doctor Philippe Guyon
Doctor Franck Digne
Centre Cardiologique du Nord
Doctor Philippe Brenot
Doctor Olivier Ledref
Doctor Rhyad Bourkaib
Centre Cardiologique d’Evecquemont
Italy
Doctor Alessandro Desideri
A.S.L. 8 Asolo
Doctor Angelo Ramondo
Azienda Ospedaliera di Padova
Doctor Alexander ABIZAID
Instituto Dante Pazzanese de Cardiologia
Doctor Breno Oliveira Almeida
Hospital Santa Marcelina
Doctor Marco Antonio Perin
Hospital Israelita Albert Einstein
France
Docteur Hakim Benamer (Coordinateur national)
Hopital Européen de Paris – La Roseraie
Docteur Jacques Berland
Docteur René Koning
Clinique Saint Hilaire
Doctor Thierry Royer
Doctor Philippe Guyon
Doctor Franck Digne
Centre Cardiologique du Nord
Doctor Philippe Brenot
Doctor Olivier Ledref
Doctor Rhyad Bourkaib
Centre Cardiologique d’Evecquemont
Italy
Doctor Alessandro Desideri
A.S.L. 8 Asolo
Doctor Angelo Ramondo
Azienda Ospedaliera di Padova
1. De novo lesions in native coronary arteries.
2. Reference diameter sup.equ 2.5 and inf.equ 3.5 mm (visual estimation).
3. Lesion length inf.equ 20 mm (visual estimation)
4. Single lesion per vessel.
5. Maximum two lesions per patient.
6. All lesions must treated with the same study device (Amazonia PAX®)
7. The patient is at least 18 years of age.
8. The patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional trial.
9. The patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergent coronary artery bypass graft (CABG) surgery.
10. The patient or patient
2. Reference diameter sup.equ 2.5 and inf.equ 3.5 mm (visual estimation).
3. Lesion length inf.equ 20 mm (visual estimation)
4. Single lesion per vessel.
5. Maximum two lesions per patient.
6. All lesions must treated with the same study device (Amazonia PAX®)
7. The patient is at least 18 years of age.
8. The patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional trial.
9. The patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergent coronary artery bypass graft (CABG) surgery.
10. The patient or patient
1. Bifurcation lesion(s) including left main.
2. Heavily calcified lesions (visual estimation)
3. Severe tortuous lesions.
4. Documented left ventricular ejection fraction (LVEF) < 30% at most recent evaluation.
5. Women of childbearing potential.
6. A known hypersensitivity or contraindication to aspirin, heparin or bivaluridin, ticlopidine or clopidogrel, cobalt chromium or stainless steel alloys, polymer coatings, contrast media, which cannot be adequately pre-medicated.
7. History of an allergic reaction or significant sensitivity to paclitaxel or drugs in similar class.
8. Chronic total occlusion (CTO).
9. A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
10. Evidence of an acute MI within 72 hours of the intended index procedure (defined as: 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. Heavily calcified lesions (visual estimation)
3. Severe tortuous lesions.
4. Documented left ventricular ejection fraction (LVEF) < 30% at most recent evaluation.
5. Women of childbearing potential.
6. A known hypersensitivity or contraindication to aspirin, heparin or bivaluridin, ticlopidine or clopidogrel, cobalt chromium or stainless steel alloys, polymer coatings, contrast media, which cannot be adequately pre-medicated.
7. History of an allergic reaction or significant sensitivity to paclitaxel or drugs in similar class.
8. Chronic total occlusion (CTO).
9. A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
10. Evidence of an acute MI within 72 hours of the intended index procedure (defined as: 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
All patients will have a clinical follow-up at 1, 6, 9 and 12 months and subsequently every year up to 5 years.