NCT05205148

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: A.O.U. Città della Salute e della Scienza · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-04-30
• Completion: 2024-12-30
• First posted: 2022-01-24
• Last updated: 2022-01-24

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study