Coronary Bifurcations, Left Main Coronary Artery Disease, Stent Restenosis, Stent Thrombosis, Very Thin Stents
Conditions
Brief summary
For permanent coronary stents, reduction of thickness of struts have become one of the most important innovation, being related to easier manipulation, reduced risk of stent thrombosis and low rate of revascularization. Consequently the investigators performed a multicenter registry enrolling all consecutive patients treated with very thin stents for ULM or bifurcation.
Detailed description
For permanent coronary stents, reduction of thickness of struts have become one of the most important innovation, being related to easier manipulation, reduced risk of stent thrombosis and low rate of revascularization. Previous studies do not have enough power to detect potential significant difference for ULM or bifurcation lesions. Consequently the investigators performed a multicenter registry enrolling all consecutive patients treated with Biomatrix Flex, Xience Alpine, Ultimaster, Resolute Onyx and Synergy. MACE (a composite end point of death, myocardial infarction, target lesion revascularization and stent thrombosis) will be the primary end point, while its single components will be the secondary ones.
Interventions
DEVICEXience alpine, ultimaster, resolute onyx, synergy
PCI will be performed
Sponsors
University Hospital, Zürich
A.O.U. Città della Salute e della Scienza
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing PCI on unprotected left main or coronary bifurcation
Exclusion criteria
* PCI performed on other coronary vessels
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Events (MACE) | 1 year | Major Adverse Cardiac Events (MACE) is a composite end-point which includes: death for any cause; non fatal myocardial infarction; target lesion revascularization (TLR); in-stent thrombosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion revascularization (TLR) | 1 year | The investigators defined Target Lesion Revascularization as either repeat percutaneous or surgical revascularization for a lesion anywhere within the stent or the 5-mm borders proximal or distal to the stent. |
| Death | 1 year | Death for any cause (both cardiologic and non-cardiologic) |
| non fatal myocardial infarction | 1 year | non fatal myocardial infarction |
| Target Vessel Revascularization (TVR) | 1 year | TVR is defined as any repeat PCI in the target vessel indicating the disease progression. |
Countries
Italy
Outcome results
None listed