NCT03544294

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,800 (actual)
• Sponsor: A.O.U. Città della Salute e della Scienza · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Xience alpine, ultimaster, resolute onyx, synergy	PCI will be performed

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-05-30
• Completion: 2018-05-30
• First posted: 2018-06-01
• Last updated: 2018-06-06

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study