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

Coronary Artery Disease Clinical Trial

— ULTRA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05205148
• Other study ID #: ULTRA registry
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2022
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: Ovidio De Filippo, MD
• Phone: +390116336023
• Email: ovidio.defilippo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 30, 2024
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Italy	Fabrizio D'Ascenzo	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

Outcome

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