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

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Status: Enrolling

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

Treatments: Device: Percutaneous coronary intervention with the following platforms: Orsiro; Mistent; BioMime; Supraflex Cruz

Study type: Observational

Funder types: Other

Identifiers

NCT05205148

ULTRA registry

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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