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

NCT03544294 | Completed DMC FDA Device

• 1 other identifier: RAIN
• Study Type: observational
• Target: 2,800
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Target Lesion revascularization (TLR)

  1 year

• Death

  1 year

• non fatal myocardial infarction

  1 year

• Target Vessel Revascularization (TVR)

  1 year

Study Arms (1)

Group

Consecutive patients treated with very thin stents on ULM and bifurcation

Device: Xience alpine, ultimaster, resolute onyx, synergy

Interventions

Xience alpine, ultimaster, resolute onyx, synergy DEVICE

PCI will be performed

Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

consecutive patients undergoing PCI

You may qualify if:

• Patients undergoing PCI on unprotected left main or coronary bifurcation

You may not qualify if:

• PCI performed on other coronary vessels

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead
• University Hospital, Zürich: collaborator

Study Sites (1)

Citta della Salute

Turin, 10128, Italy

Location

Related Publications (4)

• Choi KH, Nam CW, Bruno F, Cho YK, De Luca L, Kang J, Mattesini A, Song YB, Truffa A, Kim HS, Wanha W, Chun WJ, Gili S, Helft G, Han SH, Cortese B, Lee CH, Escaned J, Yoon HJ, Chieffo A, Hahn JY, Gallone G, Choi SH, De Ferrari G, Koo BK, Quadri G, Hur SH, D'Ascenzo F, Gwon HC, de Filippo O. Differential Prognosis of True Bifurcation Lesions According to Left Main Versus Non-Left Main Location and Treatment Strategy. J Am Heart Assoc. 2025 Feb 4;14(3):e037657. doi: 10.1161/JAHA.124.037657. Epub 2025 Feb 3.

  PMID: 39895551 DERIVED

• Choi KH, Bruno F, Cho YK, De Luca L, Song YB, Kang J, Mattesini A, Gwon HC, Truffa A, Kim HS, Wanha W, Chun WJ, Gili S, Hur SH, Helft G, Han SH, Cortese B, Lee CH, Escaned J, Yoon HJ, Chieffo A, Hahn JY, Gallone G, Choi SH, De Ferrari G, Koo BK, Quadri G, D'Ascenzo F, Nam CW, de Filippo O. Comparison of Outcomes Between 1- and 2-Stent Techniques for Medina Classification 0.0.1 Coronary Bifurcation Lesions. JACC Cardiovasc Interv. 2023 Sep 11;16(17):2083-2093. doi: 10.1016/j.jcin.2023.06.013. Epub 2023 Aug 9.

  PMID: 37565964 DERIVED

• 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.

  PMID: 32414330 DERIVED

• 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.

  PMID: 32102566 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 1, 2018
• Study Start: June 1, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

IT (1)