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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04986709
Registration number
NCT04986709
Ethics application status
Date submitted
21/07/2021
Date registered
3/08/2021
Titles & IDs
Public title
PMCF Study in Patients With Acute or Chronic Aortic Dissection or Aortic Aneurysm Treated With E-vita OPEN NEO
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Scientific title
NEOS-APAC - Asian Pacific Post-market Clinical Follow-up Study in Patients With Acute or Chronic Aortic Dissection or Aortic Aneurysm Treated With E-vita OPEN NEO
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Secondary ID [1]
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NEOS-APAC
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Universal Trial Number (UTN)
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Trial acronym
NEOS-APAC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aortic Dissection
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Aortic Aneurysm
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0
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Condition category
Condition code
Cardiovascular
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0
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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0
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Open repair
Treatment: Devices: Open repair
Open repair of the aortic arch and descending aorta with or without involvment of the ascending aorta using a hybrid graft.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mortality
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Assessment method [1]
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Rate of all-cause mortality
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Timepoint [1]
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30-day
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Secondary outcome [1]
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Mortality
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Assessment method [1]
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Rate of all-cause mortality
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Timepoint [1]
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3-6, 12, 24 months
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Secondary outcome [2]
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Mortality
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Assessment method [2]
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Rate of aortic related mortality
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Timepoint [2]
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30-day, 3-6, 12, 24 months
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Secondary outcome [3]
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Major Adverse Events
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Assessment method [3]
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Rate of patients who are free from Major Adverse Events (MAEs) (new permanent disabling stroke (mRS = 2 and at baseline mRS \< 2), new permanent (\> 30 days) paraplegia or paraparesis, reintervention (excluding reoperation for bleeding or planned or unplanned additional intervention), all-cause mortality)
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Timepoint [3]
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12 months
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Secondary outcome [4]
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Device technical success
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Assessment method [4]
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Rate of patients with device technical success
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Timepoint [4]
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24 hours
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Secondary outcome [5]
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Procedural success
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Assessment method [5]
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Rate of patients with procedural success
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Timepoint [5]
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At discharge, an avarage of 30 days
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Secondary outcome [6]
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Treatment success
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Assessment method [6]
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Rate of patients with treatment success
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Timepoint [6]
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At discharge, an avarage of 30 days, 3-6,12, 24 months
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Secondary outcome [7]
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Aortic rupture
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Assessment method [7]
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Rate of patients with aortic rupture
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Timepoint [7]
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At discharge, an avarage of 30 days, 3-6, 12, 24 months
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Secondary outcome [8]
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Additional intervention
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Assessment method [8]
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Rate of patients with planned or unplanned additional intervention
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Timepoint [8]
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At discharge, an avarage of 30 days, 3-6, 12, 24 months
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Secondary outcome [9]
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Reintervention
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Assessment method [9]
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Rate of patients with reintervention
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Timepoint [9]
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At discharge, an avarage of 30 days, 3-6, 12, 24 months
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Secondary outcome [10]
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Disabling stroke
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Assessment method [10]
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Rate of patients with new disabling stroke
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Timepoint [10]
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At discharge, an avarage of 30 days, 3-6, 12, 24 months
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Secondary outcome [11]
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Paraplegia
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Assessment method [11]
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Rate of patients with new permanent (\> 30 days) paraplegia
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Timepoint [11]
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At discharge, an avarage of 30 days, 3-6, 12, 24 months
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Secondary outcome [12]
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Paraparesis
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Assessment method [12]
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Rate of patients with new permanent (\> 30 days) paraparesis
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Timepoint [12]
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At discharge, an avarage of 30 days, 3-6, 12, 24 months
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Secondary outcome [13]
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Renal failure
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Assessment method [13]
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Rate of patients with renal failure requiring permanent (\> 90 days) dialysis or hemofiltration in a patient with a normal pre-procedure serum creatinine level
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Timepoint [13]
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At discharge, an avarage of 30 days, 3-6, 12, 24 months
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Secondary outcome [14]
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Aortic regurgitation
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Assessment method [14]
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Rate of patients with increase in aortic regurgitation grade of greater than 1 compared to pre-operative measurement
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Timepoint [14]
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At discharge, an avarage of 30 days, 3-6, 12, 24 months
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Secondary outcome [15]
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Stenosis
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Assessment method [15]
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Rate of patients with stenosis in the supra-aortic head vessels (0 - 30 %, \>30 % - 50 %, \> 50 % - 70%, \> 70%)
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Timepoint [15]
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At discharge, an avarage of 30 days, 3-6, 12, 24 months
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Secondary outcome [16]
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Patency
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Assessment method [16]
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Rate of patients with patent supra-aortic head vessels
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Timepoint [16]
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At discharge, an avarage of 30 days, 3-6, 12, 24 months
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Secondary outcome [17]
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Migration
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Assessment method [17]
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Rate of patients with retrograde migration \> 10 mm of the distal end of the stented part of E-vita OPEN NEO
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Timepoint [17]
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3-6, 12, 24 months
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Secondary outcome [18]
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Integrity
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Assessment method [18]
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Rate of patients with failure of integrity of the E-vita OPEN NEO
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Timepoint [18]
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At discharge, an avarage of 30 days, 3-6, 12, 24 months
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Secondary outcome [19]
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Endoleak type Ib (aneurysm)
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Assessment method [19]
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Rate of patients with aneurysm that have an endoleak type Ib
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Timepoint [19]
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3-6, 12, 24 months
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Secondary outcome [20]
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Endoleak type II (aneurysm)
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Assessment method [20]
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Rate of patients with aneurysm that have an endoleak type II
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Timepoint [20]
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3-6, 12, 24 months
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Secondary outcome [21]
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Endoleak type III (aneurysm)
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Assessment method [21]
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Rate of patients with aneurysm that have an endoleak type III
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Timepoint [21]
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3-6, 12, 24 months
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Secondary outcome [22]
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Endoleak type IV (aneurysm)
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Assessment method [22]
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Rate of patients with aneurysm that have an endoleak type IV
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Timepoint [22]
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3-6, 12, 24 months
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Secondary outcome [23]
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Increasing aortic diameter
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Assessment method [23]
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Rate of patients with aneurysm that have an increasing maximum aortic diameter in the stented region (E-vita OPEN NEO) compared to first post-operative CT
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Timepoint [23]
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3-6, 12, 24 months
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Secondary outcome [24]
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Stable aortic diameter
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Assessment method [24]
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Rate of patients with aneurysm that have a stable maximum aortic diameter in the stented region (E-vita OPEN NEO) compared to first post-operative CT
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Timepoint [24]
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3-6, 12, 24 months
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Secondary outcome [25]
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Decreasing aortic diameter
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Assessment method [25]
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Rate of patients with aneurysm that have a decreasing maximum aortic diameter in the stented region (E-vita OPEN NEO) compared to first post-operative CT
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Timepoint [25]
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3-6, 12, 24 months
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Secondary outcome [26]
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Endoleak type Ib (dissection)
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Assessment method [26]
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Rate of patients with dissection that have an endoleak type Ib
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Timepoint [26]
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3-6, 12, 24 months
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Secondary outcome [27]
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Endoleak II (dissection)
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Assessment method [27]
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Rate of patients with dissection that have an endoleak type II
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Timepoint [27]
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3-6, 12, 24 months
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Secondary outcome [28]
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Endoleak type R (dissection)
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Assessment method [28]
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Rate of patients with dissection that have an endoleak type R
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Timepoint [28]
0
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3-6, 12, 24 months
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Secondary outcome [29]
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Increasing or stable true lumen size
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Assessment method [29]
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Rate of patients with increasing (= 5 mm) or stable true lumen in the stented region
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Timepoint [29]
0
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3-6, 12, 24 months
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Secondary outcome [30]
0
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Stable or decreasing false lumen size
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Assessment method [30]
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Rate of patients with stable or decreasing (= - 5 mm) false lumen in the stented region
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Timepoint [30]
0
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3-6, 12, 24 months
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Secondary outcome [31]
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Obliterated false lumen in stented region
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Assessment method [31]
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Rate of patients with obliterated false lumen in the stented region
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Timepoint [31]
0
0
3-6, 12, 24 months
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Secondary outcome [32]
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Completely thrombosed false lumen in stented region
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Assessment method [32]
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Rate of patients with completely thrombosed false lumen in the stented region
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Timepoint [32]
0
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3-6, 12, 24 months
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Secondary outcome [33]
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Partially thrombosed false lumen in stented region
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Assessment method [33]
0
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Rate of patients with partially thrombosed false lumen in the stented region
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Timepoint [33]
0
0
3-6, 12, 24 months
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Secondary outcome [34]
0
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Patent false lumen in stented region
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Assessment method [34]
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Rate of patients with patent false lumen in the stented region
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Timepoint [34]
0
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3-6, 12, 24 months
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Secondary outcome [35]
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Obliterated false lumen between stent and celiac trunk
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Assessment method [35]
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Rate of patients with obliterated false lumen between the bottom of the stent and the celiac trunk
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Timepoint [35]
0
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3-6, 12, 24 months
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Secondary outcome [36]
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Completely thrombosed false lumen between stent and celiac trunk
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Assessment method [36]
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Rate of patients with completely thrombosed false lumen between the bottom of the stent and the celiac trunk
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Timepoint [36]
0
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3-6, 12, 24 months
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Secondary outcome [37]
0
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Partially thrombosed false lumen between stent and celiac trunk
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Assessment method [37]
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Rate of patients with partially thrombosed false lumen between the bottom of the stent and the celiac trunk
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Timepoint [37]
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Time Frame: 3-6, 12, 24 months
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Secondary outcome [38]
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Patent false lumen between stent and celiac trunk
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Assessment method [38]
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Rate of patients with patent false lumen between the bottom of the stent and the celiac trunk
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Timepoint [38]
0
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3-6, 12, 24 months
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Secondary outcome [39]
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Obliterated false lumen between celiac trunk and aortic bifurcation
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Assessment method [39]
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Rate of patients with obliterated false lumen between the celiac trunk and the aortic bifurcation
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Timepoint [39]
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3-6, 12, 24 months
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Secondary outcome [40]
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Completely thrombosed false lumen between celiac trunk and aortic bifurcation
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Assessment method [40]
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Rate of patients with completely thrombosed false lumen between the celiac trunk and the aortic bifurcation
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Timepoint [40]
0
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3-6, 12, 24 months
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Secondary outcome [41]
0
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Partially thrombosed false lumen between celiac trunk and aortic bifurcation
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Assessment method [41]
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Rate of patients with partially thrombosed false lumen between the celiac trunk and the aortic bifurcation
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Timepoint [41]
0
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3-6, 12, 24 months
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Secondary outcome [42]
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Patent false lumen between celiac trunk and aortic bifurcation
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Assessment method [42]
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Rate of patients with patent false lumen between the celiac trunk and the aortic bifurcation
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Timepoint [42]
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3-6, 12, 24 months
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Eligibility
Key inclusion criteria
* Patient´s age is between 18 and 75 years.
* Patient is willing and able to comply with the standard follow-up visits planned after the implantation procedure.
* Patient is willing and able to give informed consent.
* Patient satisfies one of the following categories:
* Patient has acute / subacute aortic dissection and requires repair or replacement of damaged or diseased vessels of the aortic arch (with or without involvement of the ascending aorta), and the descending aorta requires treatment, or, in the opinion of the investigator, the patient would derive clinical benefit from prophylactic treatment of the descending aorta.
* Patient has chronic aortic dissection which requires repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta with or without involvement of the ascending aorta, and the patient satisfies one or more of the following criteria:
Patient has aortic sinus, or ascending aorta, or aortic arch, or descending aorta diameter = 5.5 cm. Patient has aorta diameter < 5.5 cm and a growth rate of = 0.5 cm / year. Patient has ascending aorta diameter = 4.5 cm and requires an aortic valve repair or replacement. Patient has clinical signs of abdominal or peripheral malperfusion.
• Patient has a fusiform or saccular aortic aneurysm which requires repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta with or without involvement of the ascending aorta, and patient satisfies the following criteria:
Patient has a suitable distal sealing area in the descending thoracic aorta proximal to the celiac trunk.
And in case of fusiform aneurysm one of the following characteristics:
Patient has aortic sinus, or ascending aorta, or aortic arch, or descending aorta diameter = 5.5 cm. Patient has aorta diameter < 5.5 cm and a growth rate of = 0.5 cm / year. Patient has ascending aorta diameter = 4.5 cm and requires an aortic valve repair or replacement.
• Patient is hemodynamically stable without pharmacological support at time of admission to the hospital (stable blood pressure and heart rate, no shock).
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patient is unfit for open surgical repair involving circulatory arrest.
* Patient has known sensitivities or allergies to nitinol, polyester, platinumiridium, or polyethylene.
* Patient has systemic infection.
* Patient has endocarditis or active infection of the aorta.
* Patient has a free ruptured aorta.
* Patient has acute stroke or suspected acute stroke.
* Patient is on inotropes at time of arrival to the hospital.
* Patient needs mitral valve repair or replacement.
* Patient is enrolled or plans to be enrolled in another active study.
* Patient is pregnant or breastfeeding or planning to become pregnant during the course of the study.
* Patient has uncorrectable bleeding anomaly (i.e., thrombocytopenia).
* Patient has an eGFR < 45 ml/min/1.73m2 before the intervention
* Patient has known sensitivity to radiopaque contrast agents that cannot be adequately pre-treated.
* Patient has co-morbidity (i.e. active malignancy (progressive, stable or partial remission)) causing expected survival to be less than 3 years.
* Patient has any other medical, social or psychological problems, that in the opinion of the investigator, preclude the patient from participating in this study.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/03/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
114
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
0
0
Austin Health - Heidelberg
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Recruitment postcode(s) [1]
0
0
- Heidelberg
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Recruitment outside Australia
Country [1]
0
0
Hong Kong
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State/province [1]
0
0
Hong Kong
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Country [2]
0
0
Korea, Republic of
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State/province [2]
0
0
Seongnam
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Country [3]
0
0
Korea, Republic of
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State/province [3]
0
0
Seoul
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Country [4]
0
0
Malaysia
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State/province [4]
0
0
Kota Kinabalu
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Country [5]
0
0
Malaysia
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State/province [5]
0
0
Kuala Lumpur
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Country [6]
0
0
Singapore
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State/province [6]
0
0
Singapore
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Country [7]
0
0
Thailand
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State/province [7]
0
0
Bangkok
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
JOTEC GmbH
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The NEOS-APAC post-market clinical follow-up study is undertaken to demonstrate the safety and clinical performance of E-vita OPEN NEO in the treatment of aneurysm or dissection in the ascending aorta, aortic arch and descending thoracic aorta.
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Trial website
https://clinicaltrials.gov/study/NCT04986709
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04986709