RECCORD (Recording Courses of Vascular Diseases) Registry (RECCORD)

RECCORD - Recording Courses of Vascular Diseases

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

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 6000

Contacts and Locations

• Study Contact: Name: Ulrich Hoffmann, Prof.; Phone Number: 0049-30-20888831; Email: info@reccord.de
• Study Contact Backup: Name: Nasser Malyar, Dr.

Study Locations

• Germany
  • Bayern
    • München, Bayern, Germany, 80336
      • Recruiting
      • Klinikum der Ludwig-Maximilians Universität
      • Contact: Ulrich Hoffmann, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients undergoing endovascular revascularization for symptomatic peripheral artery disease of the lower extremities (located distal to the aorto-iliac bifurcation) will be included. The diagnosis of PAD will be derived from ICD-10 codes. Any endovascular procedure that is performed to a specifi c target lesion will be documented as operation and procedure codes (OPS codes) as they are defi ned by the German procedure classifi cation system (version 2015). Informed consent from each patient will be obtained prior to inclusion in the registry.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Endovascular Patients; 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

Collaborators and Investigators

• Sponsor: Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Vascular Diseases; Peripheral Artery Disease; Registry; Outcome; Revascularisation; Endovascular Intervention; Quality Management; Limb Amputation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Skin Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Atherosclerosis; Peripheral Vascular Diseases; Foot Ulcer; Diabetic Foot; Vascular Diseases; Ischemia; Peripheral Arterial Disease
• Other Study ID Numbers: RECCORD; DRKS00013585 (Registry Identifier: Deutsches Register Klinischer Studien); U1111-1209-6562 (Other Identifier: Universal Trial Number (UTN))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No