Clinical trial NCT03316833: The Rolex Registry (Revascularization Of LEft Main With Resolute onyX)
Official title: The ROLEX Registry (Revascularization Of LEft Main With Resolute onyX) A Multicenter Prospective Registry of the Onyx Resolute Stent for the Treatment of Unprotected Left Main Coronary Artery Disease.
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Coronary Artery Disease
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Detailed description: The ROLEX study is a prospective, non-randomized, European, multi-center registry.

Four hundred and fifty patients with unprotected left main coronary artery disease (ULMCAD) will be enrolled at up to 40 European sites. The main objective of the study is to assess the safety and efficacy of the new-generation zotarolimus-eluting stent Resolute Onyx in the treatment of ULMCAD, both isolated or in association with two- or three-vessel coronary artery disease

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

1. Clinical exclusion criteria:

   * 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
2. Angiographic exclusion criteria:

   * Left main diameter stenosis \<50%
   * SYNTAX score \>33

Primary outcomes:
measure: target lesion failure
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedale Università Padova
state: PD
city: Agrigento
country: Italy
facility: ASP 1 Agrigento - Ospedale San Giovanni di Dio
city: Arezzo
country: Italy
facility: Policlinico San Donato
city: Caserta
country: Italy
facility: Azienda Ospedaliera S.Anna e S.Sebastiano
city: Catania
country: Italy
facility: Ospedale Ferrarotto
city: Cosenza
country: Italy
facility: Ospedale civile dell'Annunziata
city: Cremona
country: Italy
facility: Azienda Socio-Sanitaria Territoriale di Cremona
city: Cuneo
country: Italy
facility: Ospedale Santa Croce e Carle
city: Grosseto
country: Italy
facility: Azienda Ospedaliera Grosseto
city: Lecce
country: Italy
facility: Ospedale Fazzi
city: Legnago
country: Italy
facility: Ospedale Mater Salutis
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico G.Martino
city: Mestre
country: Italy
facility: Ospedale dell'angelo
city: Milano
country: Italy
facility: Centro cardiologico Monzino
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Mirano
country: Italy
facility: Ospedale di Mirano
city: Monselice
country: Italy
facility: Ospedali Riuniti Padova Sud "Madre Teresa di Calcutta"
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Orbassano
country: Italy
facility: Azienda Ospedliera Universitaria San Luigi Gonzaga
city: Osio Sotto
country: Italy
facility: Policlinico San Marco
city: Palermo
country: Italy
facility: ARNAS Civico
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Pescara
country: Italy
facility: Ospedale Santo Spirito Santo
city: Peschiera Del Garda
country: Italy
facility: Casa di Cura Dott. Pederzoli
city: Reggio Calabria
country: Italy
facility: Azienda Ospedaliera Bianchi Melacrino Morelli
city: Rivoli
country: Italy
facility: Ospedale degli infermi
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Roma
country: Italy
facility: Ospedale Sandro Pertini
city: Roma
country: Italy
facility: Policlinico Gemelli
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Torino
country: Italy
facility: Ospedale Mauriziano Umberto I
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Carnaxide
country: Portugal
facility: Hospital de Santa Cruz
Study officials:
affiliation: University of Padova
name: Giuseppe Tarantini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.