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

January 19, 2022 updated by: Fabrizio D'Ascenzo, Azienda Ospedaliera Città della Salute e della Scienza di Torino

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

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.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients treated with ultrathin coronary DES for coronary bifurcation lesions, left main disease, chronic total coronary occlusion and in-stent restenosis regardless of their clinical presentation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fabrizio D'Ascenzo, PhD, AOU Città della salute e della scienza torino

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ANTICIPATED)

April 30, 2022

Study Completion (ANTICIPATED)

December 30, 2024

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

January 19, 2022

First Posted (ACTUAL)

January 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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