Ischemic Heart Diseasee-YukonNCT05703646
Safety and Clinical Performance of the Yukon Choice PC, Yukon Chrome PC & Yukon Choice Flex Stents in Routine Practice
An observational study of Ischemic Heart Disease, run by Translumina GmbH at 1 site in United Arab Emirates.
Trial summary
The goal of this observational study is to collect safety and performance information in the setting of a large-scale clinical registry. Patients meeting the selection criteria will be included, in chronological order of their implantation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Heart Disease
- How many people
- 5,000 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 30 Mar 2023to 30 Mar 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with coronary artery lesions in native coronary arteries ranging from 2.00 mm to 4.00 mm
Who may be able to join
- Any patient who was implanted only with a Yukon Choice PC, a Yukon Chrome PC or/and a Yukon Choice Flex stent within previous 2 days.
- Patient ≥ 18 years old.
- Male or non-pregnant female patient (Note: females of childbearing potential must have a negative pregnancy test prior to enrollment in the study).
Who cannot join
- Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
- Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements or impact the scientific integrity of the trial.
- Concurrent medical condition with a life expectancy of less than 12 months.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Al Qassimi hospital
Sharjah city
ALNOORYANI Arif, Arif345@yahoo.com
About this study
Official title: Safety and Clinical Performance of the Yukon Choice PC, Yukon Chrome PC & Yukon Choice Flex Sirolimus Eluting Bioabsorbable Polymer Stents Systems in Routine Clinical Practice: e-Yukon Global Registry.
The goal of this observational study is to collect safety and performance information in the setting of a large-scale clinical registry.
Patients meeting the selection criteria will be included, in chronological order of their implantation. This registry does not require any additional procedures, follow-up interventions, or ionizing radiation for patients.
The inclusion period is planned to last 2 years, starting in Q1 2023. The study will be complete when data on all patient's follow-up for one year have been collected.
Read the detailed description
- Prospective, observational, noninterventional, multicenter, international clinical registry
- Allocation: consecutively treated patients, non-randomized
- Masking: None (open label)
- Observational model: Longitudinal
- Inclusion period: 2 years
- Follow-up period: at 1 year
- Study duration: 3 years
Patients meeting the selection criteria will be included, in chronological order of their implantation. This registry does not require any additional procedures, follow-up interventions, or ionizing radiation for patients.
The inclusion period is planned to last 2 years, starting in Q1 2023. The study will be complete when data on all patient's follow-up for one year have been collected.
List of visits:
V0: During hospitalization: consultation baseline, data of the intervention and data at discharge
V1: consultation at 30 days Follow-Up
V2: consultation at 12 months Follow-Up
- Conditions
- Ischemic Heart Disease
- Keywords
- stent, ischemic heart disease, registry, international, routine practice
- Medical subject headings
- Myocardial Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure
Defined as the composite of cardiac death, target-vessel myocardial infarction and clinically indicated target lesion revascularization
Measured: 12 months
Secondary outcomes (9)
Device success
Defined as successful delivery and deployment of the assigned device at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-stent residual stenosis of <30% (by visual estimation).
Measured: 12 months
Procedure Success
Device success without the occurrence of an ischemia-driven major adverse cardiac event during the hospital stay to a maximum of first seven days post index procedure.
Measured: 12 months
All cause death
Defined as the rate of death from any cause
Measured: 12 months
Cardiac death
Defined as death resulting from cardiovascular causes
Measured: 12 months
Myocardial infarction
Defined as the rate of myocardial infarction
Measured: 12 months
Target-vessel myocardial infarction
Defined as a myocardial infarction occurring on the stented target vessel
Measured: 12 months
Clinically driven target lesion revascularization
Defined as a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication involving the target lesion
Measured: 12 months
Any revascularization
defined as clinically driven target lesion revascularization or angiographically driven target lesion revascularization, performed due to angiographic detection of significant restenosis in a patient who is clinically asymptomatic.
Measured: 12 months
Stent Thrombosis
Defined as a thrombotic occlusion of a coronary stent (definite or probable, as per Academic Research Consortium definitions)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start30 Mar 2023
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Translumina GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
- Investigators
- ROBERT BYRNE, Professor, Principal investigator, Cardiovascular Research RCSI University of Medicine and Health Sciences, Dublin, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703646
- Sponsor's protocol ID
- e-Yukon Global Registry
- Acronym
- e-Yukon
- Status last verified
- Nov 2023
- First submitted
- 19 Jan 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Clinical Performance of the Yukon Choice PC, Yukon Chrome PC & Yukon Choice Flex Sirolimus Eluting Bioabsorbable Polymer Stents Systems in Routine Clinical Practice: e-Yukon Global Registry.
- ClinicalTrials.gov ID
- NCT05703646
- Acronym / sponsor ID
- e-Yukon / e-Yukon Global Registry
- Conditions
- Ischemic Heart Disease
- Keywords
- stent, ischemic heart disease, registry, international, routine practice
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Translumina GmbHIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to collect safety and performance information in the setting of a large-scale clinical registry.
Patients meeting the selection criteria will be included, in chronological order of their implantation. This registry does not require any additional procedures, follow-up interventions, or ionizing radiation for patients.
The inclusion period is planned to last 2 years, starting in Q1 2023. The study will be complete when data on all patient's follow-up for one year have been collected.
Detailed description
- Prospective, observational, noninterventional, multicenter, international clinical registry
- Allocation: consecutively treated patients, non-randomized
- Masking: None (open label)
- Observational model: Longitudinal
- Inclusion period: 2 years
- Follow-up period: at 1 year
- Study duration: 3 years
Patients meeting the selection criteria will be included, in chronological order of their implantation. This registry does not require any additional procedures, follow-up interventions, or ionizing radiation for patients.
The inclusion period is planned to last 2 years, starting in Q1 2023. The study will be complete when data on all patient's follow-up for one year have been collected.
List of visits:
V0: During hospitalization: consultation baseline, data of the intervention and data at discharge
V1: consultation at 30 days Follow-Up
V2: consultation at 12 months Follow-Up
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with coronary artery lesions in native coronary arteries ranging from 2.00 mm to 4.00 mm
Key inclusion criteria (3 listed)
- Any patient who was implanted only with a Yukon Choice PC, a Yukon Chrome PC or/and a Yukon Choice Flex stent within previous 2 days.
- Patient ≥ 18 years old.
- Male or non-pregnant female patient (Note: females of childbearing potential must have a negative pregnancy test prior to enrollment in the study).
Key exclusion criteria (3 listed)
- Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
- Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements or impact the scientific integrity of the trial.
- Concurrent medical condition with a life expectancy of less than 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Target Lesion Failure
Time frame: 12 months
Defined as the composite of cardiac death, target-vessel myocardial infarction and clinically indicated target lesion revascularization
9 secondary outcomes
Device success
Time frame: 12 months
Procedure Success
Time frame: 12 months
All cause death
Time frame: 12 months
Cardiac death
Time frame: 12 months
Myocardial infarction
Time frame: 12 months
Target-vessel myocardial infarction
Time frame: 12 months
Clinically driven target lesion revascularization
Time frame: 12 months
Any revascularization
Time frame: 12 months
Stent Thrombosis
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ROBERT BYRNE, Professor principal investigator
Cardiovascular Research RCSI University of Medicine and Health Sciences, Dublin, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, run by Translumina GmbH at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NANCY CHUGH (+91-9996235253, drnancychugh@translumina.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.