RECCORD (Recording Courses of Vascular Diseases) Registry

NCT03448029 | Unknown DMC

• 3 other identifiers: RECCORDDRKS00013585U1111-1209-6562
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Vascular Diseases; Peripheral Artery Disease; Revascularisation; Outcome; Quality Management; Registry; Endovascular Intervention; Limb Amputation

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Endovascular Patients

Patients undergoing endovascular interventions for symptomatic PAD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• any type of endovascular interventions for symptomatic PAD
• endovascular intervention for PAD of lower extremities, i.e. below the aorto-iliac bifurcation

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Klinikum der Ludwig-Maximilians Universität

München, Bavaria, 80336, Germany

RECRUITING

Related Links

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

MeSH Terms

Conditions

Vascular Diseases; Peripheral Arterial Disease; Intermittent Claudication; Chronic Limb-Threatening Ischemia; Diabetic Foot

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes; Pathologic Processes; Ischemia; Diabetic Angiopathies; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Central Study Contacts

Ulrich Hoffmann, Prof.

CONTACT

0049-30-20888831; info@reccord.de

Nasser Malyar, Dr.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 27, 2018
• Study Start: January 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: February 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)