An observational study in Coronary Artery Disease, Coronary Stenosis and Stent Restenosis, sponsored by A.O.U. Città della Salute e della Scienza. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-01-24.
Sponsored by A.O.U. Città della Salute e della Scienza · Observational
ULTRA is a multicenter, observational, retrospective registry, enrolling consecutive patients treated with ultrathin coronary DES (coronary stent with strut thickness \< 70 um) for coronary bifurcation lesions, left main disease, chronic total coronary occlusion, and in-stent restenosis regardless of their clinical presentation. Target lesion failure (TLF a composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis) will be the primary end point, while its single components will be the secondary ones along with all-cause death, all acute myocardial infarction (excluding peri-procedural AMI), target vessel revascularization and BARC major bleedings (BARC 3-5). Due to the retrospective, observational nature of the registry, no formal sample size estimation is required. Patients complying with detailed inclusion criteria and with a minimum follow up of 6 months will be enrolled.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →A.O.U. Città della Salute e della Scienza is the lead sponsor of 63 studies on the registry; 13 are open to participants now.
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Consecutive patients treated with ultrathin coronary DES for coronary bifurcation lesions, left main disease, chronic total coronary occlusion and in-stent restenosis regardless of their clinical presentation
Treated with the following devices:
Exclusion Criteria:
Patients treated with ultrathin coronary stents (namely stents with strut thickness \< 70 um) for specific coronary disease scenarios: unprotected left main stenosis; Bifurcation coronary stenosis (with side branch diameter ≥ 2.5 mm); Chronic total coronary occlusion; In-stent restenosis
Incidence of target lesion failure (TLF)
A composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis
Time frame: Up to 2 years
Incidence of all-cause death
death from any cause
Time frame: Up to 2 years
Incidence of acute myocardial infarction (AMI)
all acute myocardial infarction excluding peri-procedural myocardial infarction
Time frame: Up to 2 years
Incidence of target vessel revascularization (TVR)
All revascularization in a vessel treated with ultrathin DES within the index procedure
Time frame: Up to 2 years
Incidence of major bleedings
Major bleedings defined according to Bleeding Academic Research Consortium (BARC 3-5)
Time frame: Up to 2 years
Incidence of cardiovascular death
Death from cardiovascular causes
Time frame: Up to 2 years
Incidence of target Vessel Myocardial Infarction
Myocardial infarction whose culprit artery is unequivocally identified as an artery treated with ultrathin Drug eluting stent within the index procedure
Time frame: Up to 2 years
Incidence of target lesion revascularization
coronary revascularization due to acute coronary syndrome or stable ischemic presentation due to a lesion previously treated with ultrathin drug eluting stent within the index procedure
Time frame: Up to 2 years
Incidence of definite stent thrombosis
stent thrombosis in a coronary segment previously treated with ultrathin drug eluting stent
Time frame: Up to 2 years
Plan to share: No
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This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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A.O.U. Città della Salute e della Scienza