IDOMENEO - Is Treatment Reality in Vascular Medicine Evidence-based and Follows Guideline Recommendations? A Project for Quality Development Exemplified by Peripheral Arterial Disease (PAD)

Sponsor

Universitätsklinikum Hamburg-Eppendorf (Other)

Overall Status

Unknown status

CT.gov ID

NCT03098290

Collaborator

GermanVasc (Other), University Heart Center Hamburg (Other), BARMER GEK Germany (Other), University of Hamburg-Eppendorf (Other)

10,000

Enrollment

Locations

Anticipated Duration (Months)

232.6

Patients Per Site

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Symptomatic Peripheral Arterial Disease Occlusive Disease of Artery of Lower Extremity Quality of Life	Procedure: Catheter-based endovascular revascularization Procedure: Bypass-Surgery Procedure: Endarterectomy

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

IDOMENEO: Multimethodical and Multistage Registry-based Longitudinal Study Project to Collect Primary Registry Data and Health Insurance Claims Data of Patients Invasively Treated for Peripheral Artery Disease (PAD) in Germany

Actual Study Start Date :

May 1, 2018

Anticipated Primary Completion Date :

Mar 31, 2021

Anticipated Study Completion Date :

Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Intermittent Claudication Mild to severe claudication	Procedure: Catheter-based endovascular revascularization (e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon) Other Names: ER Procedure: Bypass-Surgery Venous or alloplastic or comparable Bypass Other Names: Bypass Procedure: Endarterectomy Endarterectomy, Patchplasty Other Names: TEA
Ischaemic Rest Pain	Procedure: Catheter-based endovascular revascularization (e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon) Other Names: ER Procedure: Bypass-Surgery Venous or alloplastic or comparable Bypass Other Names: Bypass Procedure: Endarterectomy Endarterectomy, Patchplasty Other Names: TEA
Critical Limb Threatening Ischaemia Ulcers, Necrosis, Gangrene	Procedure: Catheter-based endovascular revascularization (e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon) Other Names: ER Procedure: Bypass-Surgery Venous or alloplastic or comparable Bypass Other Names: Bypass Procedure: Endarterectomy Endarterectomy, Patchplasty Other Names: TEA

Arm

Intervention/Treatment

Intermittent Claudication

Mild to severe claudication

Procedure: Catheter-based endovascular revascularization

(e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon)

Other Names:

Procedure: Bypass-Surgery

Venous or alloplastic or comparable Bypass

Other Names:

Bypass

Procedure: Endarterectomy

Endarterectomy, Patchplasty

Other Names:

TEA

Ischaemic Rest Pain

Procedure: Catheter-based endovascular revascularization

(e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon)

Other Names:

Procedure: Bypass-Surgery

Venous or alloplastic or comparable Bypass

Other Names:

Bypass

Procedure: Endarterectomy

Endarterectomy, Patchplasty

Other Names:

TEA

Critical Limb Threatening Ischaemia

Ulcers, Necrosis, Gangrene

Procedure: Catheter-based endovascular revascularization

(e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon)

Other Names:

Procedure: Bypass-Surgery

Venous or alloplastic or comparable Bypass

Other Names:

Bypass

Procedure: Endarterectomy

Endarterectomy, Patchplasty

Other Names:

TEA

Outcome Measures

Primary Outcome Measures

All-cause Mortality [12 Months]
Death from any reason
Lower Extremity Amputation [12 Months]
Amputation of lower extremity
Amputation-free Survival [12 Months]
Long-term-survival without any major amputation
Patency of Revascularization [12 Months]
Patency of treated vessel
Quality of Life (SF12, WIQ) [12 Months]
Combined questionnaire including 26 questions using QoL-SF12 and Walking Impairment Questionnaire
Ambulation [12 Months]
Myocardial infarction [12 Months]
Stroke or TIA [12 Months]
Stent or Graft Thrombosis [12 Months]
Functional Status [12 Months]
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 [At time of discharge (in-hospital period)]
As defined by the National Kidney Foundation.
Ankle-Brachial-Index [12 Months]
Occurrence of target vessel dissection [At time of discharge (in-hospital period)]
Any new dissection of the target vessel related to the procedure
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Symptomatic peripheral artery disease (intermittent claudication or critical limb ischemia)
Invasive treatment (open-surgical or endovascular)
Informed consent was obtained

Exclusion Criteria:

No informed consent was obtained
Acute limb ischemia without any chronic symptomatic PAD

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Zentralklinik Bad Berka GmbH	Bad Berka	Germany
2	Herz- und Gefäßzentrum Bad Bevensen	Bad Bevensen	Germany
3	Universitäts-Herzzentrum Freiburg - Bad Krozingen (UHZ)	Bad Krozingen	Germany
4	Kerckhoff-Klinik Bad Nauheim	Bad Nauheim	Germany
5	Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin	Berlin	Germany
6	Ev. Krankenhaus Hubertus	Berlin	Germany
7	HELIOS Klinikum Berlin-Buch	Berlin	Germany
8	Asklepios Klinik Birkenwerder	Birkenwerder	Germany
9	St. Josef Hospital I Katholisches Klinikum der Ruhr-Universität Bochum	Bochum	Germany
10	Gemeinschaftskrankenhaus Bonn, Haus St. Petrus	Bonn	Germany
11	GFO Kliniken Bonn, Betriebsstätte St. Marien	Bonn	Germany
12	Klinikum Chemnitz gGmbH	Chemnitz	Germany
13	Carl-Thiem-Klinikum Cottbus	Cottbus	Germany
14	Klinikum Darmstadt GmbH	Darmstadt	Germany
15	Städtisches Klinikum Dresden Friedrichstadt	Dresden	Germany
16	University Medical Center Düsseldorf	Düsseldorf	Germany
17	HELIOS Klinikum Erfurt	Erfurt	Germany
18	Elisabeth-Krankenhaus Essen	Essen	Germany
19	Frankfurter RotKreuz-Kliniken e.V.	Frankfurt	Germany
20	Universitäts-Herzzentrum Freiburg - Bad Krozingen (UHZ)	Freiburg	Germany
21	Klinikum Fulda	Fulda	Germany
22	University Heart Center Hamburg	Hamburg	Germany	20246
23	Agaplesion Diakonieklinikum Hamburg	Hamburg	Germany
24	Universitätsklinikum Jena	Jena	Germany
25	SRH-Klinikum-Karlsbad-Langensteinbach	Karlsbach	Germany
26	Klinikum Karlsruhe	Karlsruhe	Germany
27	Agaplesion Diakonie Kliniken Kassel	Kassel	Germany
28	Kath. Karl-Leisner-Klinikum I Marienhospital Kevelaer	Kevelaer	Germany
29	Universitätsklinikum Schleswig-Holstein, Campus Kiel	Kiel	Germany
30	St. Bonifatius Hospital Lingen	Lingen	Germany
31	Universitätsklinikum Schleswig-Holstein, Campus Lübeck	Lübeck	Germany
32	Klinikum Magdeburg gGmbH	Magdeburg	Germany
33	Theresienkrankenhaus Mannheim	Mannheim	Germany
34	Kliniken Maria Hilf GmbH	Mönchengladbach	Germany
35	Ev. Krankenhaus Mühlheim an der Ruhr	Mühlheim	Germany
36	HELIOS Klinikum München West	München	Germany
37	Isarklinikum München	München	Germany
38	Friedrich-Ebert-Krankenhaus Neumünster	Neumünster	Germany
39	Klinikum Peine	Peine	Germany
40	Imland Kliniken Rendsburg	Rendsburg	Germany
41	Klinikum Rheine I Mathias Spital	Rheine	Germany
42	Klinikum Stadt Soest	Soest	Germany
43	Klinikum Mutterhaus der Borromäerinnen gGmbH (Mitte)	Trier	Germany