Bifurcation Lesion, Coronary Artery Disease
Conditions
Brief summary
Evaluate the efficacy of the Inspiron Sirolimus Eluting Stent on bifurcation coronary artery lesions, in order to preserve and not compromize the side branch using the provisional stent technique.
Interventions
DEVICEInspiron Sirolimus Eluting Stent
Bifurcation treatment using provisional stent technique
Sponsors
Scitech Produtos Medicos Ltda
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with coronary artery disease on bifurcation anatomy with indication of drug eluting stent implantation , on which the side branch is ≥ 2.5 mm diameter and ostial stenosis ≤50% (Medina 1-1-0, 1-0-0, 0-1-0).
Exclusion criteria
* Acute Myocardial Infarction (STMI); * Chronic occlusion; * Cardiogenic shock; * Ejection fraction ≤ 20%; * Thrombocytopenia (≤ 50 mil); * DAPT contraindication; * Life expectancy of less than 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Stenosis | day 0 | % of stenosis on side branch after stent placement on main vessel |
Countries
Brazil
Contacts
Primary ContactMarco Wainstein, MD
Outcome results
None listed