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

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ClinicalTrials.gov Identifier: NCT03448029
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.

Tracking Information
First Submitted Date February 8, 2018
First Posted Date February 27, 2018
Last Update Posted Date January 23, 2019
Actual Study Start Date January 1, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 26, 2018)
  • Outcome Quality after Revascularization: Complications [ Time Frame: Up to 1 month ]
    Peri- and post-interventional complications (puncture-site complications & intervention-related complications over 30 days
  • Outcome Quality after Revascularization: Amputation [ Time Frame: Up to 12 months ]
    Amputation-free survival (AFS)
  • Outcome Quality after Revascularization: Survival [ Time Frame: Up to 12 months ]
    Survival at one year in CLI patients
  • Quality of Life: EQ-5D-5L questionnaire [ Time Frame: 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 [ Time Frame: Up to 12 months ]
    Number of re-interventions
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title RECCORD (Recording Courses of Vascular Diseases) Registry
Official Title RECCORD - Recording Courses of Vascular Diseases
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
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.
Condition
  • Vascular Diseases
  • Peripheral Artery Disease
  • Claudication
  • Critical Limb Ischemia
  • Diabetic Foot
Intervention Not Provided
Study Groups/Cohorts Endovascular Patients
Patients undergoing endovascular interventions for symptomatic PAD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 26, 2018)
6000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Ulrich Hoffmann, Prof. 0049-30-20888831 info@reccord.de
Contact: Nasser Malyar, Dr.
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03448029
Other Study ID Numbers RECCORD
DRKS00013585 ( Registry Identifier: Deutsches Register Klinischer Studien )
U1111-1209-6562 ( Other Identifier: Universal Trial Number (UTN) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.
Study Sponsor Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.
Collaborators Not Provided
Investigators Not Provided
PRS Account Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.
Verification Date January 2019