Recent studies have proven the benefit of single stenting in the treatment of bifurcation lesions. However, the debate is still ongoing about the added value of SB interventions in the setting of a provisional stenting approach when conducted according to European Bifurcation Club (EBC) recommendations, namely with systematic use of proximal optimization technique (POT) in order to adjust stent deployment to the two diameters of the main vessel as established by the fractal nature of coronary tree. Studies evaluating the potential benefit of kissing balloon have been conducted before the systematic use of POT. In the treatment of bifurcation lesions, the KISS (Keep sIngle Stenting Simple) study will evaluate the non-inferiority of no side branch (SB) intervention versus side branch ballooning (with or without kissing balloon inflation), in the setting of single stenting with systematic proximal optimization technique (POT). Patients will be randomized after main vessel stenting and POT if the SB is patent with a normal flow and no signs of ischemia. Read more in the CERC...
CERC is proud to announce that the recruitment of 4,300 patients in the MASTER-DAPT study was achieved before the end of last year! The MASTER DAPT study is the first randomized controlled trial aiming at ascertaining the optimal duration of antiplatelet therapy in HBR patients treated with Sirolimus-eluting bioresorbable polymer-coated stent implantation Terumo). Pr Marco Valgimigli This investigator-initiated study compares an abbreviated versus a prolonged duration of antiplatelet therapy after bioresorbable polymer-coated SES implantation (Ultimaster Tansei, Terumo, Tokyo, Japan) in 137 interventional cardiology centers. MASTER DAPT is powered to assess the non-inferiority of the abbreviated regimen with respect to the net adverse clinical and MACCE composite endpoint and the superiority in terms of major and clinically relevant bleedings. Patients from 3 continents (Europe, Asia, Oceania) have been enrolled in the study and the three best country-recruiters were the Netherlands, France and Switzerland. In addition, 5 sites reached the 100th patient’s milestone including Bern (CH) Dr. Aris Moschovitis having randomized more than 350 patients in the trial! The results of the MASTER DAPT study are planned to be presented at the EuroPCR Meeting in...
REFORM Brief summary BA9™ is a Biosensors proprietary drug. The enhanced lipophilicity should make the BA9™ drug particularly well suited for short-term local delivery from an expanded vascular (coronary) balloon into adjacent vascular tissue. Following successful animal experiments, the conduct of a first clinical study is the next logical step in the development of the BA9™ drug coated balloon (BA9-DCB). The study REFORM is, therefore, a first-in-man study. The study will seek to prove that the Biolimus A9-Drug Coated Balloon (BA9-DCB) is non-inferior to the approved CE marked Sequent Please-DCB with respect to % Diameter Stenosis (%DS) and has similar safety characteristics. The study REFORM will include patients with coronary artery disease who have an indication for interventional treatment of in-stent restenosis (ISR) in a bare-metal stent (BMS) or drug-eluting stent (DES). Patients will be followed up with clinic or phone visit at 1 month, 6 months, 12 and 24 months. The study uses a prospective, multi-center, single blind, randomized controlled design to enroll up to 201 patients. Patients who meet all the eligibility criteria will be randomized 2:1 to receive treatment with either a BA9-DCB or a Sequent Please-DCB, respectively. Primary endpoints The primary endpoint is % of Diameter Stenosis of the target segment assessed by Quantitative Coronary Analysis (QCA) at 6 months. Patients will undergo planned control angiogram after 6 months to assess the angiographic primary endpoint. CERC Services Project Management Regulatory Submissions Contract Management Monitoring SAE reporting/Meddra Coding Data Management / EDC Organisation of CEC Organisation of DSMB Corelab (QCA, Events) Countries 6 countries : UK, Ireland, Spain, Italy, Germany and South Korea Centers number Total : 30...
Electroducer Brief summary The objective of this trial is to assess the peri procedural safety of ELECTRODUCER SLEEVE device used for temporary cardiac pacing during percutaneous cardiovascular interventions, by radial and femoral routes of access. This is a pilot, prospective, multi-center, non-comparative study in 60 patients with a percutaneous cardiovascular intervention indication which requires temporary cardiac stimulation. Primary endpoints The device safety is assessed through the occurrence of bleeding complications at the access site where the ELECTRODUCER SLEEVE was used, including: Hematoma formation (EASY Classification) and Access-site Bleeding (BARC classification). CERC Services Project Management Data Management Contracts Management Monitoring & site follow up Safety and SAE reporting Countries 1 country (France) Centers number 3 centers 💡 Read more about the ELECTRODUCER device...
Sapien 3 Brief summary The objective of Sapien 3 is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander transfemoral and Certitude transapical/transaortic Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement. Primary endpoints All-cause mortality at 30 days post-index procedure CERC Services CEC Countries France, Germany, Ireland, Italy, United Kingdom Centers number 17 investigational...
