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| ID | Type | Description | Link |
|---|---|---|---|
| 01VSF16008 | Other Grant/Funding Number | German Federal Joint Committee | |
| 01VSF18035 | Other Grant/Funding Number | German Federal Joint Committee | |
| DRKS00014649 | Other Identifier | German Clinical Trials Registry |
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| Name | Class |
|---|---|
| GermanVasc | OTHER |
| University Heart Center Hamburg | UNKNOWN |
| BARMER GEK Germany | UNKNOWN |
| University of Hamburg-Eppendorf |
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The prevalence of peripheral arterial disease (PAD) and the proportion of endovascular procedures for treatment are increasing worldwide. For many cases of treatment or procedures no randomized controlled trials (RCT) or results from meta-analyses are so far available. The decision for treatment and selection of procedure is therefore not uncommonly left up to the personal expertise of the physician. The IDOMENEO study represents a multistage multimethodological project for healthcare research and quality assurance in interdisciplinary vascular medicine, which undertakes a comprehensive examination of this topic. Various methods and data sources (even routine data) are linked in a meaningful way. The essential components of the total project are implementation of a register platform (GermanVasc), which conforms to data protection and data security as well as the development of instruments for valid measurement of the quality of life of patients with PAD. The data protection-conform linking of primary data in the register and routine data of the consortium partner BARMER should also enable validation of the data sources.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent Claudication | Mild to severe claudication |
| |
| Ischaemic Rest Pain |
| ||
| Critical Limb Threatening Ischaemia | Ulcers, Necrosis, Gangrene |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter-based endovascular revascularization | Procedure | (e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon) |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality | Death from any reason | 12 Months |
| Lower Extremity Amputation | Amputation of lower extremity | 12 Months |
| Amputation-free Survival | Long-term-survival without any major amputation | 12 Months |
| Patency of Revascularization | Patency of treated vessel | 12 Months |
| Quality of Life (SF12, WIQ) | Combined questionnaire including 26 questions using QoL-SF12 and Walking Impairment Questionnaire | 12 Months |
| Ambulation | 12 Months | |
| Myocardial infarction | 12 Months | |
| Stroke or TIA | 12 Months | |
| Stent or Graft Thrombosis | 12 Months | |
| Functional Status | 12 Months | |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with symptomatic peripheral artery disease (PAD) treated invasively at certified multidisciplinary vascular centres in Germany.
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| Name | Affiliation | Role |
|---|---|---|
| Christian-Alexander Behrendt, Dr. | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zentralklinik Bad Berka GmbH | Bad Berka | Germany | ||||
| Herz- und Gefäßzentrum Bad Bevensen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29230514 | Background | Behrendt CA, Riess H, Harter M, Kriston L, Federrath H, Marschall U, Debus ES. [Guideline recommendations and quality indicators for invasive treatment of peripheral arterial disease in Germany : The IDOMENEO study for quality improvement and research in vascular medicine]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2018 Feb;61(2):218-223. doi: 10.1007/s00103-017-2676-9. German. | |
| Background | Behrendt CA, Härter M, Kriston L, Federrath H, Marschall U, Straub C, Debus ES. [IDOMENEO - Does treatment reality in vascular medicine conform to guidelines and treatment?] Gefaesschirurgie. 2017;22(1):41-47. | ||
| 29079875 |
| Label | URL |
|---|---|
| Project website (German) | View source |
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| OTHER |
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|
| Bypass-Surgery | Procedure | Venous or alloplastic or comparable Bypass |
|
|
| Endarterectomy | Procedure | Endarterectomy, Patchplasty |
|
|
| Modified Rutherford Classification |
| 12 Months |
| Foot Infection | 12 Months |
| Tissue Loss | 12 Months |
| New Revascularization | 12 Months |
| Major Adverse Cardiovascular Events (MACE, MACCE) | 12 Months |
| Major Adverse Limb Events (MALE) | 12 Months |
| Surgical Site Infection | 12 Months |
| Major Bleeding Complication | 12 Months |
| Acute kidney injury (AKI) requiring hemodialysis | As defined by the National Kidney Foundation. | At time of discharge (in-hospital period) |
| Ankle-Brachial-Index | 12 Months |
| Occurrence of target vessel dissection | Any new dissection of the target vessel related to the procedure | At time of discharge (in-hospital period) |
| Compartment Syndrome | At time of discharge (in-hospital period) |
| Graft or Device Failure | At time of discharge (in-hospital period) |
| Distal Embolisation | At time of discharge (in-hospital period) |
| Bad Bevensen |
| Germany |
| Universitäts-Herzzentrum Freiburg - Bad Krozingen (UHZ) | Bad Krozingen | Germany |
| Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin | Berlin | Germany |
| HELIOS Klinikum Berlin-Buch | Berlin | Germany |
| Asklepios Klinik Birkenwerder | Birkenwerder | Germany |
| St. Josef Hospital I Katholisches Klinikum der Ruhr-Universität Bochum | Bochum | Germany |
| Gemeinschaftskrankenhaus Bonn, Haus St. Petrus | Bonn | Germany |
| GFO Kliniken Bonn, Betriebsstätte St. Marien | Bonn | Germany |
| Klinikum Chemnitz gGmbH | Chemnitz | Germany |
| Carl-Thiem-Klinikum Cottbus | Cottbus | Germany |
| Klinikum Darmstadt GmbH | Darmstadt | Germany |
| Städtisches Klinikum Dresden Friedrichstadt | Dresden | Germany |
| University Medical Center Düsseldorf | Düsseldorf | Germany |
| HELIOS Klinikum Erfurt | Erfurt | Germany |
| Elisabeth-Krankenhaus Essen | Essen | Germany |
| Universitäts-Herzzentrum Freiburg - Bad Krozingen (UHZ) | Freiburg im Breisgau | Germany |
| Klinikum Fulda | Fulda | Germany |
| University Heart Center Hamburg | Hamburg | 20246 | Germany |
| Agaplesion Diakonieklinikum Hamburg | Hamburg | Germany |
| SRH-Klinikum-Karlsbad-Langensteinbach | Karlsbach | Germany |
| Klinikum Karlsruhe | Karlsruhe | Germany |
| Agaplesion Diakonie Kliniken Kassel | Kassel | Germany |
| St. Bonifatius Hospital Lingen | Lingen | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Lübeck | Lübeck | Germany |
| Klinikum Magdeburg gGmbH | Magdeburg | Germany |
| Theresienkrankenhaus Mannheim | Mannheim | Germany |
| Kliniken Maria Hilf GmbH | Mönchengladbach | Germany |
| Ev. Krankenhaus Mühlheim an der Ruhr | Mühlheim | Germany |
| Isarklinikum München | München | Germany |
| Klinikum Peine | Peine | Germany |
| Imland Kliniken Rendsburg | Rendsburg | Germany |
| Klinikum Rheine I Mathias Spital | Rheine | Germany |
| Klinikum Stadt Soest | Soest | Germany |
| Klinikum Mutterhaus der Borromäerinnen gGmbH (Mitte) | Trier | Germany |
| Background |
| Behrendt CA, Pridohl H, Schaar K, Federrath H, Debus ES. [Clinical registers in the twenty-first century : Balancing act between data protection and feasibility?]. Chirurg. 2017 Nov;88(11):944-949. doi: 10.1007/s00104-017-0542-9. German. |
| 28715513 | Background | Behrendt CA, Heidemann F, Haustein K, Grundmann RT, Debus ES; PSI Collaborators. Percutaneous endovascular treatment of infrainguinal PAOD: Results of the PSI register study in 74 German vascular centers. Gefasschirurgie. 2017;22(Suppl 1):17-27. doi: 10.1007/s00772-016-0202-2. Epub 2016 Oct 28. |
| 29776646 | Background | Behrendt CA, Bertges D, Eldrup N, Beck AW, Mani K, Venermo M, Szeberin Z, Menyhei G, Thomson I, Heller G, Wigger P, Danielsson G, Galzerano G, Lopez C, Altreuther M, Sigvant B, Riess HC, Sedrakyan A, Beiles B, Bjorck M, Boyle JR, Debus ES, Cronenwett J. International Consortium of Vascular Registries Consensus Recommendations for Peripheral Revascularisation Registry Data Collection. Eur J Vasc Endovasc Surg. 2018 Aug;56(2):217-237. doi: 10.1016/j.ejvs.2018.04.006. Epub 2018 May 30. |
| 29856270 | Background | Riess HC, Debus ES, Schwaneberg T, Hischke S, Maier J, Bublitz M, Kriston L, Harter M, Marschall U, Zeller T, Schellong SM, Behrendt CA. Indicators of outcome quality in peripheral arterial disease revascularisations - a Delphi expert consensus. Vasa. 2018 Oct;47(6):491-497. doi: 10.1024/0301-1526/a000720. Epub 2018 Jun 1. |
| 32088069 | Background | Behrendt CA, Peters F, Mani K. The Swinging Pendulum of Evidence: Is There a Reality Behind Results from Randomised Trials and Real World Data? Lessons Learned from the Paclitaxel Debate. Eur J Vasc Endovasc Surg. 2020 Apr;59(4):510-511. doi: 10.1016/j.ejvs.2020.01.029. Epub 2020 Feb 20. No abstract available. |
| 31526633 | Background | Hischke S, Riess HC, Bublitz MK, Kriston L, Schwaneberg T, Harter M, Bertges D, S Debus E, Behrendt CA. Quality Indicators in Peripheral Arterial Occlusive Disease Treatment: A Systematic Review. Eur J Vasc Endovasc Surg. 2019 Nov;58(5):738-745. doi: 10.1016/j.ejvs.2019.06.029. Epub 2019 Sep 13. |
| 31208079 | Background | Kaschwich M, Behrendt CA, Heydecke G, Bayer A, Debus ES, Seedorf U, Aarabi G. The Association of Periodontitis and Peripheral Arterial Occlusive Disease-A Systematic Review. Int J Mol Sci. 2019 Jun 15;20(12):2936. doi: 10.3390/ijms20122936. |
| 31121613 | Background | Behrendt CA, Schwaneberg T, Hischke S, Muller T, Petersen T, Marschall U, Debus S, Kriston L. Data Privacy Compliant Validation of Health Insurance Claims Data: the IDOMENEO Approach. Gesundheitswesen. 2020 Mar;82(S 02):S94-S100. doi: 10.1055/a-0883-5098. Epub 2019 May 23. |
| 31128987 | Background | Behrendt CA, Bjorck M, Schwaneberg T, Debus ES, Cronenwett J, Sigvant B; Acute Limb Ischaemia Collaborators. Editor's Choice - Recommendations for Registry Data Collection for Revascularisations of Acute Limb Ischaemia: A Delphi Consensus from the International Consortium of Vascular Registries. Eur J Vasc Endovasc Surg. 2019 Jun;57(6):816-821. doi: 10.1016/j.ejvs.2019.02.023. Epub 2019 May 22. |
| 30113269 | Background | Debus ES, Kriston L, Schwaneberg T, Hischke S, Riess HC, Harter M, Marschall U, Federrath H, Behrendt CA. Rationale and methods of the IDOMENEO health outcomes of the peripheral arterial disease revascularisation study in the GermanVasc registry. Vasa. 2018 Oct;47(6):499-505. doi: 10.1024/0301-1526/a000730. Epub 2018 Aug 16. |
| 31983289 | Result | Aarabi G, Raedel M, Kreutzburg T, Hischke S, Debus ES, Marschall U, Seedorf U, Behrendt CA. Periodontal treatment and peripheral arterial disease severity - a retrospective analysis of health insurance claims data. Vasa. 2020 Mar;49(2):128-132. doi: 10.1024/0301-1526/a000846. Epub 2020 Jan 27. |
| 31926836 | Result | Behrendt CA, Sedrakyan A, Peters F, Kreutzburg T, Schermerhorn M, Bertges DJ, Larena-Avellaneda A, L'Hoest H, Kolbel T, Debus ES. Editor's Choice - Long Term Survival after Femoropopliteal Artery Revascularisation with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis. Eur J Vasc Endovasc Surg. 2020 Apr;59(4):587-596. doi: 10.1016/j.ejvs.2019.12.034. Epub 2020 Jan 8. |
| 31744786 | Result | Kreutzburg T, Peters F, Riess HC, Hischke S, Marschall U, Kriston L, L'Hoest H, Sedrakyan A, Debus ES, Behrendt CA. Editor's Choice - Comorbidity Patterns Among Patients with Peripheral Arterial Occlusive Disease in Germany: A Trend Analysis of Health Insurance Claims Data. Eur J Vasc Endovasc Surg. 2020 Jan;59(1):59-66. doi: 10.1016/j.ejvs.2019.08.006. Epub 2019 Nov 16. |
| 34279120 | Result | Kotov A, Peters F, Debus ES, Zeller T, Heider P, Stavroulakis K, Remig J, Gussmann A, Hoffmann J, Friedrich O, Nolte T, Behrendt CA. The prospective GermanVasc cohort study. Vasa. 2021 Nov;50(6):446-452. doi: 10.1024/0301-1526/a000966. Epub 2021 Jul 19. |
| 36972814 | Derived | Peters F, Behrendt CA; IDOMENEO Collaborators. Limb Related Outcomes of Endovascular vs. Open Surgical Revascularisation in Patients with Peripheral Arterial Occlusive Disease: A Report from the Prospective GermanVasc Cohort Study. Eur J Vasc Endovasc Surg. 2023 Jul;66(1):85-93. doi: 10.1016/j.ejvs.2023.03.040. Epub 2023 Mar 25. |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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| ID | Term |
|---|---|
| D001026 | Coronary Artery Bypass |
| D004691 | Endarterectomy |
| D013662 | Tea |
| ID | Term |
|---|---|
| D009204 | Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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