Ignite Creation Date:
2024-05-06 @ 12:52 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03877848
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2019-03-14
Brief Title:
EluNIR Ridaforolimus Eluting Coronary Stent System in Patients at High Bleeding Risk HBR- EluNIR HBR Study
Sponsor:
Medinol Ltd
Organization:
Medinol Ltd
Study Overview
Official Title:
EluNIR Ridaforolimus Eluting Coronary Stent System in Patients at High Bleeding Risk HBR- EluNIR HBR Study
Status:
COMPLETED
Status Verified Date:
2021-08
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 study will enroll approximately 316 subjects with a wide spectrum of PCI indications stable angina as well as ACS who are considered to be at high risk of bleeding Patients will undergo PCI with implantation of the EluNIR stent followed by shortened duration 1 months in stable patients and up to 3 months in ACS patients of DAPT
Detailed Description:
This is a prospective multi-center Up to 20 sites single-arm open-label post marketing clinical trial
The objectives To assess the safety and efficacy of shortened DAPT duration 30 days in stable patients and up to 90 days in ACS patients following PCI using the EluNIR stent in patients considered to be at high bleeding risk HBR
Patients will be enrolled to the study prior to the PCI procedureOnce a patient has signed an informed consent met all general and angiographic eligibility criteria and a guidewire has successfully been passed beyond the target lesion and lesion preparation if indicated completed the patient will be enrolled into the trialData collection commences after the subject has signed the informed consent form Data collection including subject demographic information laboratory tests and procedural data as well as follow-up visits or telephone contacts will be captured by the Investigator or site coordinator who has been trained on the CIP and Case Report Forms CRF
After discharge from the hospital each subject will be followed with an in-clinic follow-up visit at 30 days and follow-up by phone at 6 months and 1year post procedure Patients with recurrent ischemic events within the first 30 days as well as patients in whom the initial presentation was ACS and in whom the investigator has decided to continue DAPT beyond 30 days will have an additional phone follow-up at 3 months
The clinical investigation will last for the expected duration of each subjects participation
Each subject will remain in the clinical investigation for approximately 1 year from the time of the study stent implantation until the last follow-up telephone contact
The trial population will consist of approximately 316 male and female subjects undergoing PCI for angina stable or unstable silent ischemia non-ST elevation MI NSTEMI considered at HBR
The objectives To assess the safety and efficacy of shortened DAPT duration 30 days in stable patients and up to 90 days in ACS patients following PCI using the EluNIR stent in patients considered to be at high bleeding risk HBR
Patients will be enrolled to the study prior to the PCI procedureOnce a patient has signed an informed consent met all general and angiographic eligibility criteria and a guidewire has successfully been passed beyond the target lesion and lesion preparation if indicated completed the patient will be enrolled into the trialData collection commences after the subject has signed the informed consent form Data collection including subject demographic information laboratory tests and procedural data as well as follow-up visits or telephone contacts will be captured by the Investigator or site coordinator who has been trained on the CIP and Case Report Forms CRF
After discharge from the hospital each subject will be followed with an in-clinic follow-up visit at 30 days and follow-up by phone at 6 months and 1year post procedure Patients with recurrent ischemic events within the first 30 days as well as patients in whom the initial presentation was ACS and in whom the investigator has decided to continue DAPT beyond 30 days will have an additional phone follow-up at 3 months
The clinical investigation will last for the expected duration of each subjects participation
Each subject will remain in the clinical investigation for approximately 1 year from the time of the study stent implantation until the last follow-up telephone contact
The trial population will consist of approximately 316 male and female subjects undergoing PCI for angina stable or unstable silent ischemia non-ST elevation MI NSTEMI considered at HBR
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?:
None
Is an FDA AA801 Violation?:
None