An Investigator Initiated Trial to Evaluate the Safety and Feasibility of the DyNETIC-35 Cobalt Chromium Balloon-expandable Stent for the Treatment of Atherosclerotic Iliac Lesions Via a Trans-radial Approach - Bionetic-TRA

This feasibility study with a 30 day follow up period will assess the safety and feasibility of the Dynetic-35 stent for the treatment of peripheral iliac artery lesions via a trans-radial approach.

Start Date25 Jul 2022

Sponsor / Collaborator

Klinikum Hochsauerland GmbH

NCT05355688 / RecruitingNot Applicable

Prospective, Single-centre Post-Market Clinical Follow-up (PMCF) Study to Evaluate Safety and Performance of the DUO Venous Stent

This observational study is to evaluate performance and safety of the DUO Venous Stent for the treatment of obstructions of the iliac vein.

Start Date06 Apr 2022

Sponsor / Collaborator

Klinikum Hochsauerland GmbH

100 Clinical Results associated with Klinikum Hochsauerland GmbH

0 Patents (Medical) associated with Klinikum Hochsauerland GmbH

Literatures (Medical) associated with Klinikum Hochsauerland GmbH

01 May 2024·Alzheimer's & Dementia

Longitudinal cerebral perfusion in presymptomatic genetic frontotemporal dementia: GENFI results

Article

Author: Graff, Caroline ; Tang-Wai, David ; Cash, David ; Strafella, Antonio P ; Thomas, David ; Seelaar, Harro ; van Swieten, John C ; Mutsaerts, Henri J M M ; Synofzik, Matthis ; Santana, Isabel ; Gerhard, Alex ; Rowe, James B ; Laforce, Robert ; Galimberti, Daniela ; Black, Sandra E ; Butler, Chris ; Ducharme, Simon ; Levin, Johannes ; Vandenberghe, Rik ; Freedman, Morris ; Otto, Markus ; Finger, Elizabeth ; Rogaeva, Ekaterina ; Tartaglia, Maria Carmela ; Sorbi, Sandro ; Russell, Lucy L ; Masellis, Mario ; Jiskoot, Lize C ; Borroni, Barbara ; Sanchez-Valle, Raquel ; MacIntosh, Bradley J ; Rohrer, Jonathan D ; Mirza, Saira S ; Luciw, Nicholas ; Bouzigues, Arabella ; Bocchetta, Martina ; Pasternak, Maurice ; Mitchell, Sara B ; de Mendonça, Alexandre ; Tiraboschi, Pietro ; Moreno, Fermin ; Petr, Jan

AbstractINTRODUCTIONEffective longitudinal biomarkers that track disease progression are needed to characterize the presymptomatic phase of genetic frontotemporal dementia (FTD). We investigate the utility of cerebral perfusion as one such biomarker in presymptomatic FTD mutation carriers.METHODSWe investigated longitudinal profiles of cerebral perfusion using arterial spin labeling magnetic resonance imaging in 42 C9orf72, 70 GRN, and 31 MAPT presymptomatic carriers and 158 non‐carrier controls. Linear mixed effects models assessed perfusion up to 5 years after baseline assessment.RESULTSPerfusion decline was evident in all three presymptomatic groups in global gray matter. Each group also featured its own regional pattern of hypoperfusion over time, with the left thalamus common to all groups. Frontal lobe regions featured lower perfusion in those who symptomatically converted versus asymptomatic carriers past their expected age of disease onset.DISCUSSIONCerebral perfusion is a potential biomarker for assessing genetic FTD and its genetic subgroups prior to symptom onset.Highlights

Gray matter perfusion declines in at‐risk genetic frontotemporal dementia (FTD).

Regional perfusion decline differs between at‐risk genetic FTD subgroups .

Hypoperfusion in the left thalamus is common across all presymptomatic groups.

Converters exhibit greater right frontal hypoperfusion than non‐converters past their expected conversion date.

Cerebral hypoperfusion is a potential early biomarker of genetic FTD.

01 Apr 2024·Vasa

Cost-effectiveness analysis of intravascular ultrasound-guided peripheral vascular interventions in patients with femoropopliteal peripheral artery disease

Article

Author: Stavroulakis, Konstantinos ; Bavière, Henri Vanden ; Lichtenberg, Michael ; Mustapha, Jihad ; Meijer, Catherina ; Tan, Yan Zhi

Summary: Background: Intravascular ultrasound (IVUS)-guided percutaneous transluminal angioplasty (PTA) might offer clinical benefits compared to angiography-guided PTA in patients with peripheral artery disease (PAD). A cost-effectiveness model was developed to examine the benefits and costs of IVUS-guided PTA versus angiography-guided PTA in PAD patients with femoropopliteal (FP) occlusive disease. Methods: A two-step model (a one-year decision tree followed by a lifetime semi-Markov model) was developed from a German healthcare payer perspective to estimate the costs and outcomes over a one-year and lifetime horizon. Clinical events included target lesion revascularization (TLR), amputation, and death. Transition probabilities and utility values were derived from published literature. Healthcare costs were based on German Diagnosis Related Groups (DRG) codes. Costs and outcomes were discounted at a rate of 3% per year. The incremental cost-effectiveness ratio (ICER) was calculated, and sensitivity analyses were performed to assess the robustness of the results. Results: In the one-year horizon, IVUS-guided PTA resulted in incremental quality-adjusted life-years (QALY) and costs of 0.02 and €919 per patient respectively, with a corresponding ICER of €45,195/QALY gained versus angiography-guided PTA. In the lifetime horizon, IVUS-guided PTA outperforms angiography-guided PTA; it was associated with a cost saving of €46 per patient and incremental QALY of 0.22. Utility value for post-TLR, as well as probabilities of death and TLR had the greatest impact on the one-year ICER, while cost of TLR and probabilities of TLR and amputation influenced the lifetime ICER most. The probability of IVUS-guided PTA being cost-effective at a willingness-to-pay (WTP) threshold of €50,000/QALY was 50.4% in the one-year horizon and increased to 85.9% in the lifetime horizon. Conclusions: In this analysis IVUS-guided PTA among patients with symptomatic FP atherosclerosis was cost-saving in a lifetime horizon from the German healthcare payer perspective.

15 Dec 2022·Open Forum Infectious Diseases

1142. Plasma with high titers of anti-SARS-Cov2 antibodies improves outcome of COVID-19 in patients with hematological malignancy and cancer in a randomized controlled trial

Author: Celik, Cihan ; Ruhe, Matthias ; Kreuter, Michael ; Meurer, Stefan ; Gall, Julia ; Weber, Stefan F ; Krisam, Johannes ; Bullinger, Lars ; Müller-Tidow, Carsten ; Kräusslich, Hans-Georg ; Vehreschild, Maria ; Weigand, Markus ; Souto-Carneiro, Margarida ; Schäkel, Ulrike ; Baumann, Lukas ; Hänel, Mathias ; Schmiedel, Stefan ; Merle, Uta ; Schrezenmeier, Jens-Florian ; Morgner, Anke ; Herth, Felix ; Addo, Marylyn ; Klemmer, Jennifer ; Schimanski, Carl ; Lorenz, Hanns-Martin ; Hertenstein, Bernd ; Kern, Winfried ; Pohle, Thorsten ; Denkinger, Claudia M ; Stelmach, Patrick ; Hopfer, Olaf ; Schmitt, Michael ; Janssen, Maike ; Schmitt, Anita ; Leo, Albrecht ; Gronkowski, Martina ; Alakel, Nael ; Wattad, Mohammad-Amen ; Stermann, Jacek ; Bartenschlager, Ralf ; Witzke, Oliver ; Schlenk, Richard ; Kriegsmann, Katharina ; Müller, Barbara ; Wolf, Timo ; Kiehl, Michael ; Tepasse, Phil-Robin ; Bornhäuser, Martin ; Halama, Niels

AbstractBackgroundPatients with hematological malignancy or other cancers as well as immunosuppression bear a high risk for severe COVID-19. Monoclonal antibodies (mAb) are efficient at early stages of the disease but may lose potency with new variants. Trials on plasma from convalescent donors in unselected patients have not shown clinical benefit. No randomized trials focussing on patients with underlying disease have been published.MethodsWe conducted an open-label, multicenter, randomized controlled trial to evaluate efficacy of plasma (CVP - convalescent or after vaccination) in patients with COVID-19 at high risk for adverse outcome in Germany. We assessed the effect of high-titer CVP (2 units from different donors, 238-337 ml each, on subsequent days). Patients with hematological or other malignancy (group 1), immunosuppression (group 2), age >50 and ≤75 years and lymphopenia and/or high D-dimers (group 3) or age >75 years (group 4) who were hospitalized with confirmed SARS-CoV-2 infection and with an oxygen saturation ≤94% were included. Primary outcome measure was time to clinical improvement on a seven-point ordinal scale, secondary outcome was mortality (Janssen et al. Trials 2020 Oct 6;21(1):828).ResultsOverall, 133 patients were randomized, 68 received CVP with an additional 10 patients as a crossover on day 10. Median age (range) was 68 years (39-95) in the CVP group and 70 (38-90) in controls. For the entire cohort, no significant difference was seen in time to improvement (median days: CVP 12.5 vs. control 18; HR 1.24 (95% confidence interval (CI) 0.83-1.85), p=0.29). Subgroup analysis (group 1+2) revealed shortened time to improvement (median days CVP 13 vs. control 32; HR 2.03 (95%CI 1.17-3.6), p=0.01) and mortality was reduced (mortality CVP n=6 (18%) vs. control n=10 (29%). No significant differences in time to improvement were observed in group 3 or 4 (HR 0.72 (95%CI 0.41-1.28), p=0.26). No relevant adverse events were observed.ConclusionCVP improves time to clinical improvement and mortality for COVID-19 patients with underlying hematological disease/cancer or other reasons of impaired immune response. Even with new variants, high-titer CVP may offer a widely available and inexpensive therapy option in high-risk groups.FundingBMBF FKZ 01KI20152; EudraCT 2020-001632-10.DisclosuresUta Merle, MD, Gilead: Sponsored congress travel and accommodation Markus Weigand, MD, Bbraun: Speakers fee/ad boards fee|Biotest: Speakers fee/ad boards fee|Eumedica: Speakers fee/ad boards fee|Gilead: Speakers fee/ad boards fee|MSD: Speakers fee/ad boards fee|Pfizer: Speakers fee/ad boards fee|Shionogi: Speakers fee/ad boards fee|SOBI: Speakers fee/ad boards fee Martin Bornhäuser, MD, Alexion: Honoraria|Jazz Pharmaceuticals: Honoraria|MSD: Honoraria|Novartis: Honoraria Nael Alakel, MD, Amgen: personal fee, travel grant|Gilead: personal fee, travel grant|MSD Sharp and Dohme GmbH: personal fee, travel grant|Pfizer: personal fee, travel grant Timo Wolf, MD, Gilead Sciences: Lecture fee, travel grant|Janssen Pharmaceuticals: Lecture fee, travel grant|Merck Sharp Dome: Lecture fee, travel grant Maria Vehreschild, Prof. Dr., 3M: speaker fee|Astellas: Advisor/Consultant|Astellas: speaker fee|biologische heilmittel heel gmbh: Grant/Research Support|BioNtech: Grant/Research Support|EUMEDICA: Advisor/Consultant|Farmak International Holding: Advisor/Consultant|Ferring: Advisor/Consultant|Ferring: Speaker fee|Gilead Sciences: Advisor/Consultant|Immunic AG: Advisor/Consultant|MaaT: Advisor/Consultant|Merck: Advisor/Consultant|Merck: speaker fee|MSD: Advisor/Consultant|MSD: Grant/Research Support|MSD: speaker fees|Pfizer: speaker fee|Roche Molecular Systems: Grant/Research Support|Roche Molecular Systems: speaker fees|SocraRTec R&D GmbH: Advisor/Consultant|Takeda California: Grant/Research Support Hanns-Martin Lorenz, MD, Abbvie: Advisor/Consultant|Abbvie: Honoraria|Actelion: Advisor/Consultant|Actelion: Honoraria|Alexion: Advisor/Consultant|Alexion: Honoraria|Amgen: Advisor/Consultant|Amgen: Grant/Research Support|Astra Zeneca: Advisor/Consultant|Astra Zeneca: Honoraria|Baxter: Advisor/Consultant|Baxter: Advisor/Consultant|Baxter: Honoraria|Baxter: Honoraria|Bayer Vital: Advisor/Consultant|Bayer Vital: Honoraria|Biogen: Advisor/Consultant|Biogen: Honoraria|BMS: Advisor/Consultant|BMS: Honoraria|Boehringer Ingelheim: Advisor/Consultant|Boehringer Ingelheim: Honoraria|Celgene: Advisor/Consultant|Celgene: Honoraria|Fresenius: Advisor/Consultant|Fresenius: Honoraria|Genzyme: Advisor/Consultant|Genzyme: Honoraria|Gilead/Galapagos: Advisor/Consultant|Gilead/Galapagos: Honoraria|GSK: Advisor/Consultant|GSK: Honoraria|Hexal: Advisor/Consultant|Hexal: Honoraria|Janssen-Cilag: Advisor/Consultant|Janssen-Cilag: Honoraria|Lilly: Advisor/Consultant|Lilly: Honoraria|Medac: Advisor/Consultant|Medac: Honoraria|MSD: Advisor/Consultant|MSD: Honoraria|Mundipharm: Advisor/Consultant|Mundipharm: Honoraria|Mylan: Advisor/Consultant|Mylan: Honoraria|Novartis: Advisor/Consultant|Novartis: Honoraria|octapharm: Advisor/Consultant|octapharm: Honoraria|Pfizer: Advisor/Consultant|Pfizer: Honoraria|Roche/Chugai: Advisor/Consultant|Roche/Chugai: Honoraria|Sandoz: Advisor/Consultant|Sandoz: Honoraria|Sanofi: Advisor/Consultant|Sanofi: Honoraria|Shire: Advisor/Consultant|Shire: Honoraria|SOBI: Advisor/Consultant|SOBI: Honoraria|Thermo Fisher: Advisor/Consultant|Thermo Fisher: Honoraria|UCB: Advisor/Consultant|UCB: Honoraria.

100 Deals associated with Klinikum Hochsauerland GmbH

100 Translational Medicine associated with Klinikum Hochsauerland GmbH

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