RECCORD (Recording Courses of Vascular Diseases) Registry

Sponsor

Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V. (Other)

Overall Status

Recruiting

CT.gov ID

NCT03448029

Collaborator

(none)

6,000

Enrollment

Location

Anticipated Duration (Months)

71.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Vascular Diseases Peripheral Artery Disease Claudication Critical Limb Ischemia Diabetic Foot

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

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

6000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

RECCORD - Recording Courses of Vascular Diseases

Actual Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Endovascular Patients Patients undergoing endovascular interventions for symptomatic PAD

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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