Diepholz, Germany

AcandiS Stenting of Intracranial STENosis - regisTry

ASSISTENT is subdivided into two components. The first part only requires recording of data acquired in routine clinical practice during the treatment of patients with intracranial stenosis with the self-expandable Credo® stent until discharge. This comprises demographic data, data concerning the qualifying clinical event, limited data on medical history and medication, information about the intervention including technical success and periprocedural complications or events, and information about events and clinical status during the in-hospital treatment until hospital discharge. The second part of the registry consists of a follow-up visit 30 days after the interventional procedure which will be conducted outside of clinical practice.

CERENOVUS Neurothrombectomy Devices Registry

The objective of this study are to separately assess the effectiveness of the CERENOVUS neurothrombectomy devices (EmboTrap® Revascularization Device, Large Bore Catheter/EMBOVAC Aspiration Catheter, and CEREGLIDE 71 Intermediate Catheter) in a real-world setting, as well as to explore correlations between patient comorbidities, clot characteristics, revascularization rates, and clinical outcomes.

Study of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment.

Vaccination Against COVID-19 in Chronic Kidney Disease

Patients on dialysis and kidney transplant patients infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus type 2) have an increased risk to develop a more severe course of disease or die from COVID-19 (coronavirus disease 2019). SARS-CoV-2 vaccination can increase protection against COVID-19. Kidney transplant patients and patients requiring dialysis suffer from an acquired immune deficiency. Due to the dysfunctional immune response, the general vaccine response in dialysis patients and kidney transplant patients is in many cases insufficient. Until now, the vaccination response in dialysis patients and kidney-transplanted patients is unpredictable. Verification of vaccine response can provide important information on how to treat and protect these patients from a COVID-19. Therefore, there is a medical need to monitor vaccine protection after SARS-CoV-2 vaccination in clinical practice. In this observational study, data of the SARS-CoV-2 vaccination response collected in clinical routine will be analyzed from these patients. Based on this observational study, the investigators aim to get first evidence whether and to what extent vaccination against COVID-19 causes a vaccine response in immunocompromised patients with kidney disease.

Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever

DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device

The purpose of the DERIVO® 2heal® trial is to conduct a post market clinical follow-up (PMCF) study of the use of the DERIVO® 2heal® Embolisation Device in clinical practice according to EU MDCGs guidance. The DERIVO® 2heal® Study is designed as a prospective, single-arm, multicenter, open-label, national study conducted in Germany with approximately 15 sites planned. The study aims to investigate potential residual risks associated with the use of the device and to update the clinical evaluation of the device in order to ensure the long-term safety and performance of the DERIVO® 2heal® Embolisation Device after its placing on the market. For this purpose, the DERIVO® 2heal® Study will systematically collect information on technical success, safety, and clinical success of treatment of intracranial aneurysms with DERIVO® 2heal® Embolisation Device in clinical practice. The study duration is expected to be 36 months of enrolment and 12 months follow-up of patients. Up to 158 patients should be enroled at approx. 15 study sites in Germany. Informed consent will be obtained from all patients prior to implantation of the DERIVO® 2heal® Embolisation Device. In exceptional cases, informed consent may be obtained after the intervention, as the study is purely data collection. It should be noted that the signed informed consent form must be obtained before recording of data in the study and prior any study-specific assessments. Informed consent process will be performed according to ICH-GCP standards. In case of emergency situations when the treatment needs to be performed immediately and informed consent cannot be given prior to the rescue treatment, the informed consent can be obtained retrospectively from the patient or patient's legal representative. The analysis population will be consist of all patients enrolled who were treated with DERIVO® 2heal® Embolisation device or in whom an attempt of DERIVO® 2heal® Embolisation device implantation was made. Personal data will be processed in accordance with the relevant national and international legislation and good clinical practice. Data will only be processed for the purpose of the PMCF study. Person-identifiable data will not leave the unit from which they originated, and for pseudonymized data, keys to identification numbers will be held confidentially by the responsible person. Individual patient's medical information will be recorded in the study only in pseudonymized form. All data in this project are captured in eCRFs and stored into an electronic clinical database. Quality control and data validation procedures such as programmed automatic edit and consistency checks ensure data validity and accuracy immediately at the point of entry into this database. The database application which is used to capture electronic clinical trial data is protected from unauthorized access it is, among other features, access restricted, contains rights and roles functionalities, provides electronic authentication of data entries, maintains an electronic audit trail and provides appropriate data backup functionalities. After data entry, study monitoring team will perform source data verification and issue monitoring queries directly in the database application. The database will only be locked after all queries and discrepancies that may have occurred during data entry have been resolved. After database lock, data will be exported in an electronic format and transferred to the responsible biometrician for analysis. The locked database may also be used to generate subject listings and tabulations. The results of the trial will be reported to the central Ethics Committees after the study was completed. By signing the protocol, the investigator agrees that the results of the clinical investigation may be used for publication. The investigator also agrees that is not permitted to publish any data related to the trial independent of the Sponsor.

REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)

Study of Oral Upadacitinib to Assess Change in Disease Activity in Adult Participants With Ulcerative Colitis

CERENOVUS Neurothrombectomy Devices Registry

The objective of this study are to separately assess the effectiveness of the CERENOVUS neurothrombectomy devices (EmboTrap® Revascularization Device, and Large Bore Catheter/EMBOVAC Aspiration Catheter) in a real-world setting, as well as to explore correlations between patient comorbidities, clot characteristics, revascularization rates, and clinical outcomes..

PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive or HER2-low Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan

Eligible participants will be those patients with documented HER2-positive unresectable or metastatic BC receiving T-DXd treatment or patients with documented HER2-low unresectable or metastatic BC receiving T DXd treatment in line with the applicable summary of product characteristics (SmPC) within routine clinical practice. All diagnostic and treatment procedures including visit frequency are at the discretion of the treating physician and not defined by the protocol. T-DXd treatment is considered as a selection criteria. Patients will be informed about use of digital healthcare application (DiGA). Approximately 800 eligible participants will be enrolled which includes 400 patients in the HER2-positive cohort and 400 patients in the HER2-low cohort.