EluNIR HBR study
Research type
Research Study
Full title
EluNIR Ridaforolimus Eluting Coronary Stent System in patients at high bleeding risk (HBR)– EluNIR HBR study
IRAS ID
260538
Contact name
Andreas Baumbach
Contact email
Sponsor organisation
Medinol Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 16 days
Research summary
Percutaneous coronary intervention (PCI) is a common medical procedure performed to treat patients suffering from narrowed coronary arteries. PCI has been shown to improve patient morbidity and mortality in acute coronary syndromes and improve patient symptoms suffering from stable angina.
Coronary drug eluting stents (DES) were developed to prevent acute and chronic occlusions of coronary arteries after PCI. However, there is a risk of stent thrombosis (ST) leading to re-occlusion of the artery and myocardial infarction. The risk is highest immediately after stent implantation and is reduced after the metal struts become covered by endothelial cells. Late ST is associated with mal-apposition of the stent, stent fracture and incomplete endothelial coverage.
DES differ in their risk of ST and this is related to many factors including the type of stent (open vs. closed-cell), strut thickness, strut material and flexibility.
Dual anti-platelet therapy (DAPT) is a combination of 2 drugs given to patents before and after PCI in order to prevent ST. Current guidelines recommend 6-12 months of DAPT after stent implantation. DAPT is associated with an increased risk of bleeding, and in patients with a high bleeding risk (HBR) shorter periods of DAPT treatment may be appropriate, balancing the risks of ischemia and bleeding. Data regarding the optimal length of DAPT treatment in HBR patients is limited.
The EluNIR stent is a new thin-strut DES that elutes ridaforolimus and is coated with an elastic co-polymer. It was designed to enable rapid and controlled stent coverage by endothelial cells.
The aim of the proposed trial is to evaluate if a shortened period of DAPT following implantation of an EluNIR stent in HBR patients is safe and effective. The information gathered by the trial may help to treat HBR patients while reducing their risk of bleeding.
The trial population will include patients undergoing routine PCI who have characteristics associated with increased bleeding such as: older age, anemia, a history of bleeding events and additional drug treatment that increases bleeding.
Patients will be treated in hospitals in Israel and the UK that perform PCI to patients suffering from myocardial ischemia.
Patients will undergo routine treatment with an EluNIR stent and then, according to their risk of ischemic and bleeding events, receive 1 to 3 months of DAPT. The investigator may, at his/her discretion continue DAPT beyond 3 months.
Patients will be followed for 12 months post procedure and ischemic and bleeding events will be recorded in detail. Follow up will include a clinic visit at 30 days and telephone contact at 3,6, and 12 months.REC name
HSC REC B
REC reference
19/NI/0110
Date of REC Opinion
7 Jun 2019
REC opinion
Further Information Favourable Opinion