EESIS-FR Brief summary This is a multicentre post marketing study in France evaluating the safety and efficacy of the eCLIPs™ Family of Products for the treatment of bifurcation intracranial aneurysms at the carotid and basilar terminus. The eCLIPs device is the first neuro device that has gained Innovation funding (in French, “Forfait innovation”) from French National Authority for Health (Haute Autorité de santé – HAS). Primary endpoints Efficacy Endpoint: Proportion of patients with aneurysms with complete occlusion (Raymond-Roy score 1) with no recurrence or re-treatment at 12 months. Safety Endpoint: Proportion of patients with a major stroke or non-accidental death within 30 days (procedural) or with a major ipsilateral stroke or neurological death between 31 days and 12 months. CERC Services Study documents review Project management Sites’ contract management EDC and data management Monitoring activities Safety reporting CEC and DSMB activities Final study report Countries France Centers number...
PHYSIO PCI Brief summary A Prospective, single-center , open label study to evaluate impact of coronary angioplasty on non-hyperhaemic pressure ratio in patients with coronary artery disease The principal objective of the study is to evaluate the impact of stenting in all-comers patients with coronary artery disease treated by PCI. The impact will be evaluated by physiological assessment (RFR measurement) before and after optimized PCI. Primary endpoints The primary endpoint will be the comparison between RFR before and after optimized PCI 3 (RFRpre vs. RFRfinal) in all included lesions. CERC Services Kick off activities, Clinical trial documentation, Regulatory submissions, Project management, eCRF management, Monitoring, SAE reporting activities, Statistical activities. Countries United Arab Emirates. Centers number 1 center managed by...
TARGET FIRST Brief summary TARGET FIRST is a prospective, international, multicentre, open-label, randomized (1:1) post-market study to evaluate the impact of Firehawk stent, a drug eluting stent (DES) with high biocompatibility feature, associated with a complete revascularization when needed and short post-procedural Dual Antiplatelet Therapy (DAPT) (consisting of a reduced duration of DAPT followed by P2Y12 inhibitor monotherapy up to 12 months), in reaching non-inferior Net Adverse Clinical and Cerebral Events (NACCE) among clinically stable, low to moderate complexity acute Myocardial Infarction (MI) patients. The secondary objective is to evaluate the impact of Firehawk stent, associated with a complete revascularization when needed and a short post-procedural DAPT, in reducing bleeding events among clinically stable, low to moderate complexity acute MI patients. Primary endpoints Net Adverse Clinical and Cerebral Events (NACCE) defined as a composite of all cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, stroke, or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 11 months post randomization (12 months post index procedure). CERC Services Site qualification Regulatory Submissions (except in France) Project Management Data Management Contracts Management (except in France) Monitoring SAE Reporting CEC Countries 8 (Austria, Belgium, France, Italy, The Netherlands, Portugal, Spain, Switzerland) Centers number Approximately 50...
Compare HBR 60 80 Brief summary An Investigator-initiated, multi-center, randomized controlled trial to compare the outcome of the ultrathin stent strut Supraflex Cruz stent to the thin stent strut Ultimaster Tansei stent in a PCI population at high bleeding risk. Primary endpoints Net Adverse Clinical Endpoints (NACE) defined as a composite of cardiovascular death, MI, TVR, stroke and major bleeding events (BARC 3 or 5) at 12 months. CERC Services Kick-off activities Clinical trials documentation Project management Clinical Events Committee (CEC) activities Corelab activities Data monitoring Committee (DMC) activities Statistical activities Administrative tasks Countries The Netherlands Centers number 10 centers managed by...
Illumina Brief summary The Illumina study has been designed to evaluate the efficacy and safety of the new self-expanding polymer free drug eluting stent – NiTiDES – for SFA manufactured by CID S.p.A. member of Alvimedica group. Currently this device represents the first attempt to embed a controlled and targeted drug elution (2-3 months) with a polymer-free nitinol Platform. Illumina is a prospective and single arm study, which enrolled 100 patients with ischemic obstruction of SFA and proximal popliteal artery. The two co-primary endpoints for the study are primary patency rate at 12 months – efficacy endpoint, and composite event free survival rate at 12 months – safety endpoint. The trial principle investigator is Prof. Dierk Scheinert from Leipzig University hospital. NiTiDES is a polymer free stent eluting the Amphilimus™ formulation (a combination of Sirolimus and Fatty Acid) through the Abluminal Reservoir Technology aiming at obtaining the highest efficacy profile for the patient. The polymer free platform, which is made of Nitinol, is integrally covered by the Bio Inducer Surface coating, a 2nd generation pure carbon ultra thin layer that drastically increases haemo and bio-compatibility. Primary endpoints SAFETY: Composite event–free survival at 12 months: freedom from CEC adjudicated MAE (death, target limb amputation, target limb ischemia requiring surgical intervention or surgical repair of target vessel or clinically-driven target lesion revascularization) and freedom from worsening of the Rutherford score by 2 classes, or to class 5 or 6 EFFICACY: Primary patency at 12 months. Primary patency is defined as absence of clinically-driven target lesion revascularization or binary restenosis. Binary restenosis is defined as a peak systolic velocity ratio (PSVR) >2.4...
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...
