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

Recruiting

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

• Registration Number: NCT05205148
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2022-01
• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-19
• Last Update Submitted: 2022-01-19
• Study First Posted: 2022-01-24
• Last Update Posted: 2022-01-24
• Primary Completion: 2022-04-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of target lesion failure (TLF)	Up to 2 years	A composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis

Secondary Outcome Measures

Name	Time	Method
Incidence of acute myocardial infarction (AMI)	Up to 2 years	all acute myocardial infarction excluding peri-procedural myocardial infarction
Incidence of definite stent thrombosis	Up to 2 years	stent thrombosis in a coronary segment previously treated with ultrathin drug eluting stent
Incidence of target lesion revascularization	Up to 2 years	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
Incidence of all-cause death	Up to 2 years	death from any cause
Incidence of cardiovascular death	Up to 2 years	Death from cardiovascular causes
Incidence of target Vessel Myocardial Infarction	Up to 2 years	Myocardial infarction whose culprit artery is unequivocally identified as an artery treated with ultrathin Drug eluting stent within the index procedure
Incidence of target vessel revascularization (TVR)	Up to 2 years	All revascularization in a vessel treated with ultrathin DES within the index procedure
Incidence of major bleedings	Up to 2 years	Major bleedings defined according to Bleeding Academic Research Consortium (BARC 3-5)

Trial Locations

Locations (1)

Fabrizio D'Ascenzo; 🇮🇹 Torino, Italy