RECCORD (Recording Courses of Vascular Diseases) Registry

Study Overview
=================
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

Official Title
-----------------
RECCORD - Recording Courses of Vascular Diseases

Conditions
-----------------
Claudication, Vascular Diseases, Peripheral Artery Disease, Critical Limb Ischemia, Diabetic Foot

Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endovascular Patients<br>Patients undergoing endovascular interventions for symptomatic PAD | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome Quality after Revascularization: Complications | Peri- and post-interventional complications (puncture-site complications & intervention-related complications over 30 days | Up to 1 month | 
| Outcome Quality after Revascularization: Amputation | Amputation-free survival (AFS) | Up to 12 months | 
| Outcome Quality after Revascularization: Survival | Survival at one year in CLI patients | Up to 12 months | 
| Quality of Life: EQ-5D-5L questionnaire | EQ-5D-5L questionnaire to asses patient's health state and patient's self-rated health | At baseline, at 6 and 12 months | 
| Outcome Quality after Revascularization: Re-Intervention | Number of re-interventions | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vascular Diseases, Revascularisation, Outcome, Quality Management, Registry, Endovascular Intervention, Limb Amputation, Peripheral Artery Disease