RECCORD (Recording Courses of Vascular Diseases) Registry

Peripheral Artery Disease Clinical Trial

— RECCORD  

Official title:

RECCORD - Recording Courses of Vascular Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03448029
• Other study ID #: RECCORD
• Secondary ID: DRKS00013585U111
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2021
• Source: Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.
• Contact: Ulrich Hoffmann, Prof.
• Phone: 0049-30-20888831
• Email: info[@]reccord.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Claudication
• Critical Limb Ischemia
• Diabetic Foot
• Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Vascular Diseases

Locations

Country	Name	City	State
Germany	Klinikum der Ludwig-Maximilians Universität	München	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome Quality after Revascularization: Complications	Peri- and post-interventional complications (puncture-site complications & intervention-related complications over 30 days	Up to 1 month
Primary	Outcome Quality after Revascularization: Amputation	Amputation-free survival (AFS)	Up to 12 months
Primary	Outcome Quality after Revascularization: Survival	Survival at one year in CLI patients	Up to 12 months
Primary	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
Primary	Outcome Quality after Revascularization: Re-Intervention	Number of re-interventions	Up to 12 months

External Links

•   Official RECCORD Homepage
•   Rationale and design of the RECording COurses of vasculaR Diseases registry (RECCORD registry), Vasa (2017), 46, pp. 262-267