- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05205148
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
Status
Recruiting
Conditions
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
- Name: Ovidio De Filippo, MD
- Phone Number: +390116336023
- Email: ovidio.defilippo@gmail.com
Study Locations
-
-
-
Torino, Italy, 10126
- Recruiting
- Fabrizio D'Ascenzo
-
Contact:
- Fabrizio D'Ascenzo, PhD
- Phone Number: 0116336705
- Email: fabrizio.dascenzo@gmail.com
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-
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ULTRA registry
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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