veRy Thin Stents for Patients With Left mAIn or bifurcatioN in Real Life: the RAIN a Multicenter Study

Stent Thrombosis Clinical Trial

— RAIN  

Official title:

veRy Thin Stents for Patients With Left mAIn or bifurcatioN in Real Life: the RAIN a Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03544294
• Other study ID #: RAIN
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: June 2018
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Bifurcations
• Coronary Disease
• Left Main Coronary Artery Disease
• Myocardial Ischemia
• Stent Restenosis
• Stent Thrombosis
• Thrombosis
• Very Thin Stents

Intervention

Device:
• Xience alpine, ultimaster, resolute onyx, synergy
PCI will be performed

Locations

Country	Name	City	State
Italy	Citta della Salute	Turin

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino	University Hospital, Zürich

Country where clinical trial is conducted

Italy, 

Outcome

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