Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04713683
Status:
RECRUITING
Last Update Posted:
2023-09-11
First Post:
2021-01-11
Brief Title:
Investigation of Nickel Sensitization After Percutaneous Implantation of Patent Foramen Ovale Occluder
Sponsor:
National and Kapodistrian University of Athens
Organization:
National and Kapodistrian University of Athens
Study Overview
Official Title:
Investigation of Nickel Sensitization After Percutaneous Implantation of Patent Foramen Ovale Occluder a RandomizEd Trial
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSPIRE
Brief Summary:
Percutaneous PFO closure has been established as a first-line therapy for preventing recurrent strokes in selected patients The devices used for the specific purpose contain and release nickel which is considered as the most allergen metal in nature Skin patch tests are considered as gold-standard for documenting nickel allergy While the allergic contact dermatitis induced by nickel is well described literature is inadequate on explaining the effect of nickel release on the clinical manifestations of patients implanted with such devices
Our prospective randomized blinded trial will try to investigate the above by performing nickel skin patch tests to all patients 14 days before and 90 days after the implantation During follow-up clinical manifestations and transthoracic echocardiographic findings will be evaluated and associated with patch skin tests
Our prospective randomized blinded trial will try to investigate the above by performing nickel skin patch tests to all patients 14 days before and 90 days after the implantation During follow-up clinical manifestations and transthoracic echocardiographic findings will be evaluated and associated with patch skin tests
Detailed Description:
Percutaneous PFO closure has been established as a first-line therapy for preventing recurrent strokes after embolic stroke of unknown source ESUS and a patent foramen ovale The PFO closure is achieved by the implantation of suitable devices which occlude the shunt between the two atria and prevent the creation and detachment of thrombi Until today there are two devices approved by FDA for the specific purpose Amplatzer PFO Occluder and Gore Cardioform Septal Occluder Despite the architectonic differences between these devices the main material of both is nitinol an alloy of nickel and titanium While titanium is an extremely rare allergen nickel is considered as one of the most common allergens and the most frequent metal allergen in nature with a prevalence about 20 The main clinical expression of nickel hypersensitivity is allergic contact dermatitis but cases with systemic allergic reaction have been described as well It has been observed that nickel is released by the implanted devices and circulates through bloodstream having the potential to cause systemic clinical picture Device syndrome includes signs and symptoms ie palpitations dyspnea chest pain rash etc which are appeared after the device placement and are associated with hypersensitivity reaction The existing literature is considered as inadequate for explaining the effect of nickel release in the patients implanted with an occluder
Our trial will try to investigate the impact of device placement to nickel skin patch test results and the correlation with the clinical manifestations of patients Considering that skin patch tests for nickel and other allergens will be performed in all included patients 14 days prior and 90 days after the procedure The patients will be randomized to receive either Amplatzer or Gore device with parallel assignment and randomization 11 During follow-up clinical manifestations and transthoracic echocardiographic findings will be evaluated and associated with patch skin tests The time frame of 90 days has been selected due to the duration of devices endothelization and nickel release
Our trial will try to investigate the impact of device placement to nickel skin patch test results and the correlation with the clinical manifestations of patients Considering that skin patch tests for nickel and other allergens will be performed in all included patients 14 days prior and 90 days after the procedure The patients will be randomized to receive either Amplatzer or Gore device with parallel assignment and randomization 11 During follow-up clinical manifestations and transthoracic echocardiographic findings will be evaluated and associated with patch skin tests The time frame of 90 days has been selected due to the duration of devices endothelization and nickel release
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None