Coronary Artery DiseaseRolexNCT03316833
The Rolex Registry (Revascularization Of LEft Main With Resolute onyX)
An observational study of Coronary Artery Disease, run by University of Padova at 33 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Resolute Onyx
- Type of treatment
- Medical device
- How many people
- 450 participants
- Where
- 33 sitesin 2 countries
- Study dates
- 1 Nov 2017to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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%)
Show all 13Show fewer
- 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
- Angiographic exclusion criteria:
- Left main diameter stenosis <50%
- SYNTAX score >33
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
Italy32 sites
ASP 1 Agrigento - Ospedale San Giovanni di Dio
Agrigento
Policlinico San Donato
Arezzo
Azienda Ospedaliera S.Anna e S.Sebastiano
Caserta
Ospedale Ferrarotto
Catania
Ospedale civile dell'Annunziata
Cosenza
Azienda Socio-Sanitaria Territoriale di Cremona
Cremona
Ospedale Santa Croce e Carle
Cuneo
Azienda Ospedaliera Grosseto
Grosseto
Ospedale Fazzi
Lecce
Ospedale Mater Salutis
Legnago
Azienda Ospedaliera Universitaria Policlinico G.Martino
Messina
Ospedale dell'angelo
Mestre
Centro cardiologico Monzino
Milan
Ospedale San Raffaele
Milan
Ospedale di Mirano
Mirano
Ospedali Riuniti Padova Sud "Madre Teresa di Calcutta"
Monselice
Azienda Ospedaliera Universitaria Federico II
Naples
Azienda Ospedliera Universitaria San Luigi Gonzaga
Orbassano
Policlinico San Marco
Osio Sotto
Azienda Ospedale Università Padova
Padova, PD, 35128
ARNAS Civico
Palermo
Fondazione IRCCS Policlinico San Matteo
Pavia
Ospedale Santo Spirito Santo
Pescara
Casa di Cura Dott. Pederzoli
Peschiera del Garda
Azienda Ospedaliera Bianchi Melacrino Morelli
Reggio Calabria
Ospedale degli infermi
Rivoli
Azienda Ospedaliera San Camillo Forlanini
Roma
Ospedale Sandro Pertini
Roma
Policlinico Gemelli
Roma
Azienda Ospedaliera Universitaria Senese
Siena
Ospedale Mauriziano Umberto I
Torino
Azienda Ospedaliera Universitaria Integrata Verona
Verona
About this study
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.
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.
Read the 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
- Conditions
- Coronary Artery Disease
- Being tested
- Resolute Onyx
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resolute OnyxDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
target lesion failure
composite of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start1 Nov 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2025 (estimated)
Why it stopped: Waiting for a protocol amendment to extend follow-up lenght
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Tarantini, MD, PhD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316833
- Sponsor's protocol ID
- ROLEX_2017
- Acronym
- Rolex
- Status last verified
- Jan 2023
- First submitted
- 6 Oct 2017
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 36043326
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03316833
- Acronym / sponsor ID
- Rolex / ROLEX_2017
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Waiting for a protocol amendment to extend follow-up lenght
- Enrolment
- 450 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- Clinical exclusion criteria:
- Angiographic exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resolute OnyxPercutaneous 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 | Device | – |
Primary outcome
target lesion failure
Time frame: 12 months
composite of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Derived from this study: PubMed 36043326Tarantini 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.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Tarantini, MD, PhD principal investigator
University of Padova
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University of Padova at 33 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Italy, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
target lesion failure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03316833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.