Trials / Completed
CompletedNCT03098290
IDOMENEO - Is Treatment Reality in Vascular Medicine Evidence-based and Follows Guideline Recommendations? A Project for Quality Development Exemplified by Peripheral Arterial Disease (PAD)
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 5,608 (actual)
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
- Symptomatic Peripheral Arterial Disease
- Occlusive Disease of Artery of Lower Extremity
- Quality of Life
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Catheter-based endovascular revascularization | (e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon) |
| PROCEDURE | Bypass-Surgery | Venous or alloplastic or comparable Bypass |
| PROCEDURE | Endarterectomy | Endarterectomy, Patchplasty |
Timeline
- Start date
- 2018-05-01
- Primary completion
- 2021-03-31
- Completion
- 2021-04-01
- First posted
- 2017-03-31
- Last updated
- 2022-12-22
Locations
35 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT03098290. Inclusion in this directory is not an endorsement.