Clinicals
Trial
Trial Cardiology
PAX A Clinical Trial - Trial ID: MIN0801
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 A clinical trial will enroll 30 patients with a 1:1 randomization Amazonia PAX®:TAXUS® Liberté
The PAX A clinical trial will enroll 30 patients with a 1:1 randomization Amazonia PAX®:TAXUS® Liberté
1. Percentage of neointimal hyperplesia obstruction by IVUS at 4 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 in-stent Late Lumen Loss (LLL) at 4 months post-procedure.
4. Angiographic Binary Restenosis (ABR) rate and Minimum Luminal Diameter (MLD) at 4 months post-procedure.
5. Angiographic parameters (in-stent and in-segment) including percent Diameter Stenosis (%DS) at 4 months post-procedure.
6. Major Adverse Cardiac Event (MACE) rate at 30 days, 4 and 9 months post-procedure.
Other point:
Percentage of stent coverage by OCT at 4 months post-procedure.
2. Acute success (device, lesion, and procedure).
3. Angiographic in-stent Late Lumen Loss (LLL) at 4 months post-procedure.
4. Angiographic Binary Restenosis (ABR) rate and Minimum Luminal Diameter (MLD) at 4 months post-procedure.
5. Angiographic parameters (in-stent and in-segment) including percent Diameter Stenosis (%DS) at 4 months post-procedure.
6. Major Adverse Cardiac Event (MACE) rate at 30 days, 4 and 9 months post-procedure.
Other point:
Percentage of stent coverage by OCT at 4 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
1. De novo lesion in a native coronary artery.
2. Reference diameter
2. Reference diameter
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. A known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, ticlopidine or clopidogrel, cobalt chromium or stainless steel alloys, polymer coatings, contrast media, which cannot be adequately pre-medicated.
6. History of an allergic reaction or significant sensitivity to paclitaxel or drugs in similar class.
7. Chronic total occlusion (CTO).
8. A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
9. 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. Heavily calcified lesions (visual estimation).
3. Severe tortuous lesions.
4. Documented Left Ventricular Ejection Fraction (LVEF) < 30% at most recent evaluation.
5. A known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, ticlopidine or clopidogrel, cobalt chromium or stainless steel alloys, polymer coatings, contrast media, which cannot be adequately pre-medicated.
6. History of an allergic reaction or significant sensitivity to paclitaxel or drugs in similar class.
7. Chronic total occlusion (CTO).
8. A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
9. 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
All patients will have a clinical follow-up at 1, 4, 9 and 12 months and subsequently every year up to 5 years.
