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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- A.O.U. Città della Salute e della Scienza
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Incidence of target lesion failure (TLF)
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
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.
Investigators
Fabrizio D'Ascenzo
Clinical Professor
A.O.U. Città della Salute e della Scienza
Eligibility Criteria
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:
- •Supraflex Cruz
Exclusion Criteria
- •patients died during the index revascularization procedure
Outcomes
Primary Outcomes
Incidence of target lesion failure (TLF)
Time Frame: Up to 2 years
A composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis
Secondary Outcomes
- Incidence of acute myocardial infarction (AMI)(Up to 2 years)
- Incidence of definite stent thrombosis(Up to 2 years)
- Incidence of target lesion revascularization(Up to 2 years)
- Incidence of all-cause death(Up to 2 years)
- Incidence of cardiovascular death(Up to 2 years)
- Incidence of target Vessel Myocardial Infarction(Up to 2 years)
- Incidence of target vessel revascularization (TVR)(Up to 2 years)
- Incidence of major bleedings(Up to 2 years)