Disease of the circulatory system
Conditions
Interventions
Experimental group: 375 patients will be submitted to angioplasty to receive the TCD-10023 stent. Control Group: 125 patients will be submitted to angioplasty to receive the Kaname stent.
Patients wi
Device
Procedure/surgery
Sponsors
Instituto Dante Pazzanese de Cardiologia
Real e Benemérita Associação Portuguesa de Beneficência
Hospital Bandeirantes
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Age equal or more than 18 years; Chest pain > 20 minutes; Primary PCI 1 mm in > 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of > 1 mm in > 2 contiguous anterior leads; Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.5-4.0 mm in diameter that can be covered with one or multiple stents; Signed informed consent
Exclusion criteria
Exclusion criteria: Female of childbearing potential (age < 50 and last menstruation within the last 12 months), who did not underwent tubal ligation, ovariectomy or hysterectomy; Known intolerance to aspirin, clopidogrel, heparin, bivalirudin, cobalt, chromium, nickel, sirolimus or contrast material; Currently participating in another trial before reaching primary endpoint; Mechanical complication of acute myocardial infarction (e.g. cardiogenic shock…); Acute myocardial infarction secondary to stent thrombosis; Previously stented infarction related artery (IRA); Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period; Patients with non-cardiac comorbid conditions with life expectancy < 1 year or that may result in protocol non-compliance; History of bleeding diathesis or known coagulopathy; Use of oral anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluating trough the occurrence of all-cause death, recurrent MI, unplanned Infarct Related Artery revascularization, stroke, definite stent thrombosis or major bleeding at 1 month.;Efficacy evaluation trough the verification by angiographic analysis of in-stent late loss at 6 months post stent implantation in a subset of 100 patients in pre-defined hospitals. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the procedure success and device efficacy trough the occurrence of target lesion revascularization, target vessel revascularization, non target vessel/lesion revascularization, stent thrombosis, cardiac death, re-infarction, bleeding and vascular complications until 30 days, 6 months, 12 months, and annually, for 3 years. | — |
Countries
Brazil
Contacts
Public ContactJuliana de Castro
Cardiovascular Research Center
Outcome results
None listed