Trial document
DRKS00014649
Trial Description
Title
GermanVasc-Registry within the IDOMENEO study
Trial Acronym
IDOMENEO
URL of the Trial
Brief Summary in Lay Language
The government-funded registry-based IDOMENEO-study will consecutively include 10,000 patients with invasive revascularisations for symptomatic peripheral arterial disease performed at approximately 30-40 German vascular centres utilizing the GermanVasc registry system.
Brief Summary in Scientific Language
The study is a prospective non-randomized registry trial including invasive endovascular (ER) and open-surgical (OR) revascularisations of chronic symptomatic peripheral arterial disease (PAD) of the lower extremities performed in 30-40 legally endorsed multidisciplinary German hospitals. All patients matching the inclusion criteria are consecutively included for an enrolment period of six months or until 10,000 patients have been included in the study registry. There are three follow-up measures at 3 months, 6 months and 12 months. The study outcomes consist of indicators of outcome quality defined by consensual agreement among experts in the field of vascular medicine. Plausibility-checks for integrity of submitted data are implemented into the registry system and all data needs to be verified by a physician employed in the participating study centre. Furthermore, the study data will undergo an independent quality assurance for internal validity by random-sample cross-checking against local patient files.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00014649
- 2018/05/07
- 2017/03/31
- yes
- Approved
- PV5691, Ethik-Kommission der Ärztekammer Hamburg
Secondary IDs
- NCT03098290 (clinicaltrials.gov)
Health Condition or Problem studied
- I70.2 - Atherosclerosis of arteries of extremities
Interventions/Observational Groups
- Catheter-based endovascular revascularization
- Endarterectomy
- Bypass surgery
Characteristics
- Non-interventional
- Epidemiological study
- Other
- Open (masking not used)
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- Other
- Treatment
- Other
- N/A
- N/A
Primary Outcome
Before discharge, after 3 months, after 6 months, after 12 months:
Major Adverse Cardiovascular Events (MACE)
Major Adverse Limb Events (MALE)
Myocardial Infarction
Stroke or TIA
Major Amputation
Major Reintervention
Any Reintervention
Wound Infection
Vascular Access-related Major Complication
Maximum Walking Distance
Rutherford-Classification
Ankle-Brachial-Index
Secondary Outcome
Evaluated at time of discharge, after 3 months, after 6 months, and after 12 months:
Minor Amputation
Primary Patency
Secondary Patency
Quality of Life
Healing of Wound Infections or Wound Healing Disorders
Lymphatic Fistula
Ambulation
Technical Success
Patient Satisfaction
Total Length of Hospital Stay
Functional Status
Hospital-acquired Infection
Cathether-related Infection
Ankle-Brachial-Index
Countries of Recruitment
- Germany
Locations of Recruitment
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
Recruitment
- Actual
- 2018/05/01
- 10000
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
Invasive open-surgical (endarterectomy, bypass surgery) or catheter-based endovascular revascularizations of symptomatic peripheral arterial disease
Exclusion Criteria
No informed consent
Patient <18 years
Addresses
-
start of 1:1-Block address primary-sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Martinistr. 52
- 20246 Hamburg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
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- http://www.uke.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Universitätsklinikum Hamburg-Eppendorf,Klinik und Poliklinik für Gefäßmedizin,Arbeitsgruppe GermanVasc
- Mr. Dr. med. Christian-Alexander Behrendt
- Martinistr. 52
- 20246 Hamburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0049-40-7410-18087
- 0049-40-7410-54840
- ch.behrendt at uke.de
- http://www.uke.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Universitätsklinikum Hamburg-Eppendorf,Klinik und Poliklinik für Gefäßmedizin,Arbeitsgruppe GermanVasc
- Mr. Dr. med. Christian-Alexander Behrendt
- Martinistr. 52
- 20246 Hamburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0049-40-7410-18087
- 0049-40-7410-54840
- ch.behrendt at uke.de
- http://www.uke.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
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- Innovationsausschuss beim Gemeinsamen Bundesausschuss
- Mr. Prof. Dr. Josef Hecken
- Wegelystr. 8
- 10623 Berlin
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
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- info at if.g-ba.de
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end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
- Ethikvotum der federführenden Ethikkommission Hamburg
- Behrendt CA, et al. IDOMENEO - Ist die Versorgungsrealität in der Gefäßmedizin Leitlinien und Versorgungsgerecht. Gefässchirurgie 2017;22:41-47.
- Behrendt CA, et al. Leitlinienempfehlungen in der PAVK Therapie. Bundesgesundheitsbl 2018;61:218-223.