Clinical trial NCT05205148: Ultrathin DES in Complex PCI Scenarios: the ULTRA a Multicenter Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Coronary Stenosis
Stent Restenosis
Left Main Coronary Artery Disease
Chronic Total Occlusion of Coronary Artery
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


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:

* Orsiro
* Mistent
* BioMime
* Supraflex Cruz

Exclusion Criteria:

* patients died during the index revascularization procedure

Primary outcomes:
measure: Incidence of target lesion failure (TLF)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Incidence of all-cause death
timeFrame: Up to 2 years
measure: Incidence of acute myocardial infarction (AMI)
timeFrame: Up to 2 years
measure: Incidence of target vessel revascularization (TVR)
timeFrame: Up to 2 years
measure: Incidence of major bleedings
timeFrame: Up to 2 years
measure: Incidence of cardiovascular death
timeFrame: Up to 2 years
measure: Incidence of target Vessel Myocardial Infarction
timeFrame: Up to 2 years
measure: Incidence of target lesion revascularization
timeFrame: Up to 2 years
measure: Incidence of definite stent thrombosis
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Fabrizio D'Ascenzo
Study officials:
affiliation: AOU Città della salute e della scienza torino
name: Fabrizio D'Ascenzo, PhD
role: PRINCIPAL_INVESTIGATOR
References: