Chronic Total Occlusion of Coronary Artery, Coronary Artery Disease, Coronary Stenosis, Left Main Coronary Artery Disease, Stent Restenosis
Conditions
Brief summary
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.
Interventions
DEVICEPercutaneous coronary intervention with the following platforms: Orsiro; Mistent; BioMime; Supraflex Cruz
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
Sponsors
A.O.U. Città della Salute e della Scienza
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* age \> 18 years old * Unprotected left main stenosis * Bifurcation coronary stenosis (with side branch diameter ≥ 2.5 mm) * Chronic total coronary occlusion * In-stent restenosis Treated with the following devices: * Orsiro * Mistent * BioMime * Supraflex Cruz
Exclusion criteria
* patients died during the index revascularization procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of target lesion failure (TLF) | Up to 2 years | A composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute myocardial infarction (AMI) | Up to 2 years | all acute myocardial infarction excluding peri-procedural myocardial infarction |
| Incidence of target vessel revascularization (TVR) | Up to 2 years | All revascularization in a vessel treated with ultrathin DES within the index procedure |
| Incidence of major bleedings | Up to 2 years | Major bleedings defined according to Bleeding Academic Research Consortium (BARC 3-5) |
| Incidence of all-cause death | Up to 2 years | death from any cause |
| Incidence of target Vessel Myocardial Infarction | Up to 2 years | Myocardial infarction whose culprit artery is unequivocally identified as an artery treated with ultrathin Drug eluting stent within the index procedure |
| Incidence of target lesion revascularization | Up to 2 years | 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 |
| Incidence of definite stent thrombosis | Up to 2 years | stent thrombosis in a coronary segment previously treated with ultrathin drug eluting stent |
| Incidence of cardiovascular death | Up to 2 years | Death from cardiovascular causes |
Countries
Italy
Contacts
Primary ContactOvidio De Filippo, MD
Outcome results
None listed