Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412250
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-08
Brief Title:
A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR SECURE Global Registry
Sponsor:
Translumina Therapeutics LLP
Organization:
Translumina Therapeutics LLP
Study Overview
Official Title:
A Prospective Open-Label Multi-Country Multicentre Observational PoSt Market SurvEillance of VIVO ISAR Polymer-Free Sirolimus Eluting Coronary Stent System In Real World Patients Undergoing PCI With Short Dual Antiplatelet Therapy
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
The objective of this post marketing observational registry is to evaluate clinical outcomes safety and performance in an all-comers population with coronary artery disease CAD treated with the Polymer Free Sirolimus Eluting Coronary Stent Vivo ISAR and planned for an abbreviated 3 months dual antiplatelet therapy DAPT regimen
Detailed Description:
This study is a prospective observational multi-country multi-Centre single-arm registry designed to evaluate the clinical safety and performance of VIVO ISAR Polymer Free Sirolimus Eluting Coronary Stent System The study population is made up of subjects who have undergone PCI using VIVO ISAR and are receiving standard of care short DAPT treatment 3 months Subjects will be screened by site teams and offered the opportunity to participate in the registry after their procedure Rationale for this study is to evaluate clinical outcomes and collect data of the Polymer Free Sirolimus Eluting Coronary Stent in real world CAD patients with follow-up at 1 month 3 months and 12 months
All medications and procedures to be used performed in this registry are commonly usedperformed for clinical indications as part of standard of care and have well-defined safety profiles
The study does not influence the choice of device utilized nor does it alter the routine standard of care After a patient has been treated with the Vivo ISAR informed consent will be requested and the eligible patient will be registered in the study
Baseline data will be completed using medical notes All recruited subjects will then be followed as per routine practice together with telephonic follow-up at 30 days 3 months and 12 months from the baseline PCI procedure date
The 30 day 3 months and 12 month telephonic follow up will consist of a verbally report of the DAPT anticoagulation medications continued about any lab assessments that might have happened recording of any adverse events and any interventional treatment that has occurred since previous contact
All medications and procedures to be used performed in this registry are commonly usedperformed for clinical indications as part of standard of care and have well-defined safety profiles
The study does not influence the choice of device utilized nor does it alter the routine standard of care After a patient has been treated with the Vivo ISAR informed consent will be requested and the eligible patient will be registered in the study
Baseline data will be completed using medical notes All recruited subjects will then be followed as per routine practice together with telephonic follow-up at 30 days 3 months and 12 months from the baseline PCI procedure date
The 30 day 3 months and 12 month telephonic follow up will consist of a verbally report of the DAPT anticoagulation medications continued about any lab assessments that might have happened recording of any adverse events and any interventional treatment that has occurred since previous contact
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None