The Rolex Registry (Revascularization Of LEft Main With Resolute onyX)

NCT03316833 | Suspended FDA Device

• 1 other identifier: ROLEX_2017
• Study Type: observational
• Target: 450
• Locations: 2 countries
• Sites: 33

Brief Summary

The primary objective of this study is to assess the safety and efficacy of the new-generation zotarolimus-eluting stent Resolute Onyx in the treatment of unprotected left main coronary artery disease (ULMCAD), both isolated or in association with two- or three-vessel coronary artery disease.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• target lesion failure

  composite of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization

  12 months

Interventions

Resolute Onyx DEVICE

Percutaneous coronary revascularization of patients with unprotected left main coronary artery disease up to intermediate anatomical complexity (defined by a SYNTAX score \<33), must be performed with the exclusive use of drug-eluting stents of the Resolute Onyx TM family

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with unprotected left main coronary artery disease up to intermediate anatomical complexity (defined by a SYNTAX score \<33), considered amenable for percutaneous coronary intervention (PCI).

You may qualify if:

• Subject \> 18 years old
• ULMCAD with angiographic diameter stenosis \>50% (if 50-70% evidence of FFR \<0.80 or IVUS minimal lumen area \<6.0 mm2 is recommended.
• Silent ischemia, stable angina, unstable angina or non-ST elevation myocardial infarction
• Ability to provide written informed consent and comply with follow-up for at least 2 years.

You may not qualify if:

• Prior PCI on the left main trunk or prior CABG.
• Concomitant indication to cardiac surgery (severe heart valve disease etc.)
• Cardiogenic Shock (Killip\>2)
• Severe renal insufficiency (GFR \<30 ml/min)
• Known impaired left ventricular function (left ventricular ejection fraction \<30%)
• Inability to tolerate or comply with dual antiplatelet therapy for at least 1 year
• Pregnancy or intention to become pregnant
• Life expectancy less than 1 year
• Other investigational drug or device studies that have not reached their primary endpoint
• Left main diameter stenosis \<50%
• SYNTAX score \>33

Sponsors & Collaborators

• University of Padova: lead

Study Sites (33)

Azienda Ospedale Università Padova

Padua, PD, 35128, Italy

Location

ASP 1 Agrigento - Ospedale San Giovanni di Dio

Agrigento, Italy

Location

Policlinico San Donato

Arezzo, Italy

Location

Azienda Ospedaliera S.Anna e S.Sebastiano

Caserta, Italy

Location

Ospedale Ferrarotto

Catania, Italy

Location

Ospedale civile dell'Annunziata

Cosenza, Italy

Location

Azienda Socio-Sanitaria Territoriale di Cremona

Cremona, Italy

Location

Ospedale Santa Croce e Carle

Cuneo, Italy

Location

Azienda Ospedaliera Grosseto

Grosseto, Italy

Location

Ospedale Fazzi

Lecce, Italy

Location

Ospedale Mater Salutis

Legnago, Italy

Location

Azienda Ospedaliera Universitaria Policlinico G.Martino

Messina, Italy

Location

Ospedale dell'angelo

Mestre, Italy

Location

Centro cardiologico Monzino

Milan, Italy

Location

Ospedale San Raffaele

Milan, Italy

Location

Ospedale di Mirano

Mirano, Italy

Location

Ospedali Riuniti Padova Sud "Madre Teresa di Calcutta"

Monselice, Italy

Location

Azienda Ospedaliera Universitaria Federico II

Napoli, Italy

Location

Azienda Ospedliera Universitaria San Luigi Gonzaga

Orbassano, Italy

Location

Policlinico San Marco

Osio Sotto, Italy

Location

ARNAS Civico

Palermo, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Location

Ospedale Santo Spirito Santo

Pescara, Italy

Location

Casa di Cura Dott. Pederzoli

Peschiera del Garda, Italy

Location

Azienda Ospedaliera Bianchi Melacrino Morelli

Reggio Calabria, Italy

Location

Ospedale degli infermi

Rivoli, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Roma, Italy

Location

Ospedale Sandro Pertini

Roma, Italy

Location

Policlinico Gemelli

Roma, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, Italy

Location

Ospedale Mauriziano Umberto I

Torino, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

Location

Hospital de Santa Cruz

Carnaxide, Portugal

Location

Related Publications (1)

• Tarantini G, Fovino LN, Varbella F, Trabattoni D, Caramanno G, Trani C, De Cesare N, Esposito G, Montorfano M, Musto C, Picchi A, Sheiban I, Gasparetto V, Ribichini FL, Cardaioli F, Sacca S, Cerrato E, Napodano M, Martinato M, Azzolina D, Ando G, Mugnolo A, Caruso M, Rossini R, Passamonti E, Teles RC, Rigattieri S, Gregori D, Tamburino C, Burzotta F. A large, prospective, multicentre study of left main PCI using a latest-generation zotarolimus-eluting stent: the ROLEX study. EuroIntervention. 2023 Feb 6;18(13):e1108-e1119. doi: 10.4244/EIJ-D-22-00454.

  PMID: 36043326 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 Officials

• Giuseppe Tarantini, MD, PhD

  University of Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: October 20, 2017
• Study Start: November 1, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2025
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

PT (1); IT (32)