Status:
SUSPENDED
The Rolex Registry (Revascularization Of LEft Main With Resolute onyX)
Lead Sponsor:
University of Padova
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-99 years
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...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
- Angiographic exclusion criteria:
- Left main diameter stenosis \<50%
- SYNTAX score \>33
Key Trial Info
Start Date :
November 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT03316833
Start Date
November 1 2017
End Date
December 31 2025
Last Update
January 31 2023
Active Locations (33)
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1
Azienda Ospedale Università Padova
Padua, PD, Italy, 35128
2
ASP 1 Agrigento - Ospedale San Giovanni di Dio
Agrigento, Italy
3
Policlinico San Donato
Arezzo, Italy
4
Azienda Ospedaliera S.Anna e S.Sebastiano
Caserta, Italy