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Clinical Trials/NCT05205148
NCT05205148
Recruiting
Not Applicable

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

A.O.U. Città della Salute e della Scienza1 site in 1 country1,000 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
A.O.U. Città della Salute e della Scienza
Enrollment
1000
Locations
1
Primary Endpoint
Incidence of target lesion failure (TLF)
Status
Recruiting
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
December 30, 2024
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
A.O.U. Città della Salute e della Scienza
Responsible Party
Principal Investigator
Principal Investigator

Fabrizio D'Ascenzo

Clinical Professor

A.O.U. Città della Salute e della Scienza

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:
  • Supraflex Cruz

Exclusion Criteria

  • patients died during the index revascularization procedure

Outcomes

Primary Outcomes

Incidence of target lesion failure (TLF)

Time Frame: Up to 2 years

A composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis

Secondary Outcomes

  • Incidence of acute myocardial infarction (AMI)(Up to 2 years)
  • Incidence of definite stent thrombosis(Up to 2 years)
  • Incidence of target lesion revascularization(Up to 2 years)
  • Incidence of all-cause death(Up to 2 years)
  • Incidence of cardiovascular death(Up to 2 years)
  • Incidence of target Vessel Myocardial Infarction(Up to 2 years)
  • Incidence of target vessel revascularization (TVR)(Up to 2 years)
  • Incidence of major bleedings(Up to 2 years)

Study Sites (1)

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