Stent Thrombosis Clinical Trial
— RAINOfficial title:
veRy Thin Stents for Patients With Left mAIn or bifurcatioN in Real Life: the RAIN a Multicenter Study
NCT number | NCT03544294 |
Other study ID # | RAIN |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2017 |
Est. completion date | May 30, 2018 |
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.
Status | Completed |
Enrollment | 2800 |
Est. completion date | May 30, 2018 |
Est. primary completion date | May 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients undergoing PCI on unprotected left main or coronary bifurcation Exclusion Criteria: - PCI performed on other coronary vessels |
Country | Name | City | State |
---|---|---|---|
Italy | Citta della Salute | Turin |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Città della Salute e della Scienza di Torino | University Hospital, Zürich |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major Adverse Cardiac Events (MACE) | 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. | 1 year | |
Secondary | Target Lesion revascularization (TLR) | 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. | 1 year | |
Secondary | Death | Death for any cause (both cardiologic and non-cardiologic) | 1 year | |
Secondary | non fatal myocardial infarction | non fatal myocardial infarction | 1 year | |
Secondary | Target Vessel Revascularization (TVR) | TVR is defined as any repeat PCI in the target vessel indicating the disease progression. | 1 year |
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