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

Completed

• Conditions: Coronary Bifurcations; Very Thin Stents; Stent Restenosis; Left Main Coronary Artery Disease; Stent Thrombosis
• Interventions: Device: Xience alpine, ultimaster, resolute onyx, synergy

• Registration Number: NCT03544294
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2018-05-18
• Primary Completion: 2018-05-30
• Study Completion: 2018-05-30
• Study First Submitted QC: 2018-05-31
• Status Verified: 2018-06
• Study First Posted: 2018-06-01
• Last Update Submitted: 2018-06-04
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2800

Inclusion Criteria

• Patients undergoing PCI on unprotected left main or coronary bifurcation

Exclusion Criteria

• PCI performed on other coronary vessels

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group	Xience alpine, ultimaster, resolute onyx, synergy	Consecutive patients treated with very thin stents on ULM and bifurcation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Target Vessel Revascularization (TVR)	1 year	TVR is defined as any repeat PCI in the target vessel indicating the disease progression.
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

Trial Locations

Locations (1)

Citta della Salute; 🇮🇹 Turin, Italy