Status:
UNKNOWN
INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique
Lead Sponsor:
Scitech Produtos Medicos Ltda
Conditions:
Bifurcation Lesion
Coronary Artery Disease
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- Acute Myocardial Infarction (STMI);
- Chronic occlusion;
- Cardiogenic shock;
- Ejection fraction ≤ 20%;
- Thrombocytopenia (≤ 50 mil);
- DAPT contraindication;
- Life expectancy of less than 12 months.
Key Trial Info
Start Date :
February 28 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 15 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03780192
Start Date
February 28 2019
End Date
February 15 2022
Last Update
March 17 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil