Principal
Investigator
(International): |
Dr.
Alexandre Abizaid |
| Title: |
A
Prospective and Retrospective, Multinational
Investigation of the Supralimus® and Supralimus-Core™ Sirolimus- |
| |
Eluting
Stents for the Treatment of Coronary Lesions in
Unselected Patients in the “Real-World” Clinical
Practice – |
| |
E-SERIES Registry |
| Study
Objectives: |
To
evaluate the procedural and clinical outcomes of the
Supralimus® and Supralimus-Core™ SES in the
treatment |
| |
of unselected, high risk patients in the real-world
clinical practice. |
| Study Design: |
Prospective and retrospective, multinational (Asia
and South America), non-randomized, post-marketing
web- |
| |
based registry |
| Clinical
Sites: |
Up to 100 clinical sites in Asia and South America. |
| Follow-up: |
All patients will
undergo follow-up clinical evaluation at 1, 6, 12
and 24 months. Angiographic follow-up will be |
| |
performed in
accordance to medical indication. Data of those
patients submitted to angiographic follow-up will
also |
| |
be included in the
data base. |
| Status: |
Ongoing |
| Primary
Endpoint: |
MAJOR ADVERSE CARDIAC EVENTS (MACE) at 12 months clinical follow-up |
| Secondary
Endpoints: |
1. Rates of
procedural success
|
| |
2. Rates of MACE at
in-hospital, 30 days, 6 and 24 months |
| |
3. Rates of target
lesion revascularization (TLR) at 6 and 12 months |
| |
4. Rates of stent
thrombosis (acute, sub-acute, late and very-late) up
to 24 months follow-up |
| |
|
