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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 2800

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10128
    • Città della Salute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

consecutive patients undergoing PCI

Description

Inclusion Criteria:

• Patients undergoing PCI on unprotected left main or coronary bifurcation

Exclusion Criteria:

• PCI performed on other coronary vessels

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group; Consecutive patients treated with very thin stents on ULM and bifurcation	Device: Xience alpine, ultimaster, resolute onyx, synergy; PCI will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Death	Death for any cause (both cardiologic and non-cardiologic)	1 year
non fatal myocardial infarction	non fatal myocardial infarction	1 year
Target Vessel Revascularization (TVR)	TVR is defined as any repeat PCI in the target vessel indicating the disease progression.	1 year

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Collaborators: University Hospital, Zürich

Publications and helpful links

General Publications

• Iannaccone M, Barbero U, De Benedictis M, Imori Y, Quadri G, Trabattoni D, Ryan N, Venuti G, Montabone A, Wojakowski W, Rognoni A, Helft G, Parma R, De Luca L, Autelli M, Boccuzzi G, Mattesini A, Templin C, Cerrato E, Wanha W, Smolka G, Huczek Z, Tomassini F, Cortese B, Capodanno D, Chieffo A, Nunez-Gil I, Gili S, Bassignana A, di Mario C, Doronzo B, Omede P, D'Amico M, Tedeschi D, Varbella F, Luscher T, Sheiban I, Escaned J, Rinaldi M, D'Ascenzo F. Comparison of bioresorbable vs durable polymer drug-eluting stents in unprotected left main (from the RAIN-CARDIOGROUP VII Study). BMC Cardiovasc Disord. 2020 May 15;20(1):225. doi: 10.1186/s12872-020-01420-5.
• Gaido L, D'Ascenzo F, Imori Y, Wojakowski W, Saglietto A, Figini F, Mattesini A, Trabattoni D, Rognoni A, Tomassini F, Bernardi A, Ryan N, Muscoli S, Helft G, De Filippo O, Parma R, De Luca L, Ugo F, Cerrato E, Montefusco A, Pennacchi M, Wanha W, Smolka G, de Lio G, Bruno F, Huczek Z, Boccuzzi G, Cortese B, Capodanno D, Omede P, Mancone M, Nunez-Gil I, Romeo F, Varbella F, Rinaldi M, Escaned J, Conrotto F, Burzotta F, Chieffo A, Perl L, D'Amico M, di Mario C, Sheiban I, Gagnor A, Giammaria M, De Ferrari GM. Impact of Kissing Balloon in Patients Treated With Ultrathin Stents for Left Main Lesions and Bifurcations: An Analysis From the RAIN-CARDIOGROUP VII Study. Circ Cardiovasc Interv. 2020 Mar;13(3):e008325. doi: 10.1161/CIRCINTERVENTIONS.119.008325. Epub 2020 Feb 27.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: May 31, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 4, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Embolism and Thrombosis; Coronary Disease; Coronary Artery Disease; Thrombosis
• Other Study ID Numbers: RAIN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No