veRy Thin Stents for Patients With Left mAIn or bifurcatioN in Real Life: the RAIN a Multicenter Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stent Restenosis
- Sponsor
- A.O.U. Città della Salute e della Scienza
- Enrollment
- 2800
- Locations
- 1
- Primary Endpoint
- Major Adverse Cardiac Events (MACE)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Fabrizio D'Ascenzo
Principal Investigator
A.O.U. Città della Salute e della Scienza
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing PCI on unprotected left main or coronary bifurcation
Exclusion Criteria
- •PCI performed on other coronary vessels
Outcomes
Primary Outcomes
Major Adverse Cardiac Events (MACE)
Time Frame: 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 Outcomes
- Target Vessel Revascularization (TVR)(1 year)
- Target Lesion revascularization (TLR)(1 year)
- Death(1 year)
- non fatal myocardial infarction(1 year)