RECCORD (Recording Courses of Vascular Diseases) Registry

Recruiting

• Conditions: Critical Limb Ischemia; Vascular Diseases; Peripheral Artery Disease; Claudication; Diabetic Foot

• Registration Number: NCT03448029
• Lead Sponsor: Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.

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

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-26
• Study First Posted: 2018-02-27
• Status Verified: 2021-01
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-05
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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: Complications	Up to 1 month	Peri- and post-interventional complications (puncture-site complications \& intervention-related complications over 30 days
Outcome Quality after Revascularization: Re-Intervention	Up to 12 months	Number of re-interventions
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

Trial Locations

Locations (1)

Klinikum der Ludwig-Maximilians Universität; 🇩🇪 München, Bayern, Germany