An observational study in Ischemic Heart Disease, sponsored by Translumina GmbH. Recruiting at 1 site in United Arab Emirates. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-11-27.
Sponsored by Translumina GmbH · Observational
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.
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
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 294 across 1,241 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →Translumina GmbH is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with coronary artery lesions in native coronary arteries ranging from 2.00 mm to 4.00 mm
Exclusion Criteria:
Target Lesion Failure
Defined as the composite of cardiac death, target-vessel myocardial infarction and clinically indicated target lesion revascularization
Time frame: 12 months
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).
Time frame: 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.
Time frame: 12 months
All cause death
Defined as the rate of death from any cause
Time frame: 12 months
Cardiac death
Defined as death resulting from cardiovascular causes
Time frame: 12 months
Myocardial infarction
Defined as the rate of myocardial infarction
Time frame: 12 months
Target-vessel myocardial infarction
Defined as a myocardial infarction occurring on the stented target vessel
Time frame: 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
Time frame: 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.
Time frame: 12 months
Stent Thrombosis
Defined as a thrombotic occlusion of a coronary stent (definite or probable, as per Academic Research Consortium definitions)
Time frame: 12 months
Plan to share: No
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