Claudication, Critical Limb Ischemia, Diabetic Foot, Peripheral Artery Disease, Vascular Diseases
Conditions
Keywords
Vascular Diseases, Peripheral Artery Disease, Revascularisation, Outcome, Quality Management, Registry, Endovascular Intervention, Limb Amputation
Brief summary
The RECording COurses of vasculaR Diseases registry (RECCORD registry) is an observational, prospective, multicentre, all-comers registry platform. In the initial phase, patients referred for endovascular revascularization of peripheral artery disease (PAD) of the lower limbs will be prospectively included and followed up for at least one year. At baseline, data on patients' demographic characteristics, comorbidities, previous peripheral interventions, medication, and clinical stage of PAD (Rutherford category), haemodynamic parameters, and procedural data including complications will be assessed. Major adverse cardiac and limb events will be recorded at planned (at six and 12 months) and at any unplanned visits. For details see NM Malyar et al., Rationale and design of the RECording COurses of vasculaR Diseases registry (RECCORD registry). Vasa. https://doi.org/10.1024/0301-1526/a000631
Detailed description
For details see NM Malyar et al., Rationale and design of the RECording COurses of vasculaR Diseases registry (RECCORD registry). Vasa. https://doi.org/10.1024/0301-1526/a000631
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* any type of endovascular interventions for symptomatic PAD * endovascular intervention for PAD of lower extremities, i.e. below the aorto-iliac bifurcation
Exclusion criteria
* patients undergoing hybrid-(surgical and endovascular) and/or surgical interventions for symptomatic PAD * patients with a life expectancy of \<6 months * endovascular intervention for reasons other than symptomatic PAD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Outcome Quality after Revascularization: Complications | Up to 1 month | Peri- and post-interventional complications (puncture-site complications & intervention-related complications over 30 days |
| Outcome Quality after Revascularization: Amputation | Up to 12 months | Amputation-free survival (AFS) |
| Outcome Quality after Revascularization: Survival | Up to 12 months | Survival at one year in CLI patients |
| Quality of Life: EQ-5D-5L questionnaire | At baseline, at 6 and 12 months | EQ-5D-5L questionnaire to asses patient's health state and patient's self-rated health |
| Outcome Quality after Revascularization: Re-Intervention | Up to 12 months | Number of re-interventions |
Countries
Germany