Ultrathin DES in Complex PCI Scenarios: the ULTRA a Multicenter Study

Study Overview
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Brief Summary
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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.

Official Title
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Ultrathin Drug Eluting Stents for Patients With Left-main, bifurcaTion, chRonic totAl Occlusion, or In-stent Restenosis Coronary Lesion in Real Life: the ULTRA a Multicenter Study

Conditions
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Coronary Artery Disease, Coronary Stenosis, Stent Restenosis, Left Main Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery

Intervention / Treatment
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* Device: Percutaneous coronary intervention with the following platforms: Orsiro; Mistent; BioMime; Supraflex Cruz


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Percutaneous 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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of target lesion failure (TLF) | A composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all-cause death | death from any cause | Up to 2 years | 
| Incidence of acute myocardial infarction (AMI) | all acute myocardial infarction excluding peri-procedural myocardial infarction | Up to 2 years | 
| Incidence of target vessel revascularization (TVR) | All revascularization in a vessel treated with ultrathin DES within the index procedure | Up to 2 years | 
| Incidence of major bleedings | Major bleedings defined according to Bleeding Academic Research Consortium (BARC 3-5) | Up to 2 years | 
| Incidence of cardiovascular death | Death from cardiovascular causes | 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 | 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 | Up to 2 years | 
| Incidence of definite stent thrombosis | stent thrombosis in a coronary segment previously treated with ultrathin drug eluting stent | Up to 2 years |