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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Study Description
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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


Condition or disease
Vascular Diseases Peripheral Artery Disease Claudication Critical Limb Ischemia Diabetic Foot

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: RECCORD - Recording Courses of Vascular Diseases
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Endovascular Patients
Patients undergoing endovascular interventions for symptomatic PAD


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Outcome Quality after Revascularization: Amputation [ Time Frame: Up to 12 months ]
    Amputation-free survival (AFS)

  3. Outcome Quality after Revascularization: Survival [ Time Frame: Up to 12 months ]
    Survival at one year in CLI patients

  4. 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

  5. Outcome Quality after Revascularization: Re-Intervention [ Time Frame: Up to 12 months ]
    Number of re-interventions


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448029


Contacts
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Contact: Ulrich Hoffmann, Prof. 0049-30-20888831 info@reccord.de
Contact: Nasser Malyar, Dr.

Locations
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Germany
Klinikum der Ludwig-Maximilians Universität Recruiting
München, Bayern, Germany, 80336
Contact: Ulrich Hoffmann, Prof.         
Sponsors and Collaborators
Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.
More Information
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Additional Information:

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Responsible Party: Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.
ClinicalTrials.gov Identifier: NCT03448029    
Other Study ID Numbers: RECCORD
DRKS00013585 ( Registry Identifier: Deutsches Register Klinischer Studien )
U1111-1209-6562 ( Other Identifier: Universal Trial Number (UTN) )
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.:
Vascular Diseases
Peripheral Artery Disease
Revascularisation
Outcome
 Quality Management
Registry
Endovascular Intervention
Limb Amputation
Additional relevant MeSH terms:
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Diabetic Foot
Vascular Diseases
Peripheral Arterial Disease
Ischemia
Pathologic Processes
Diabetic Angiopathies
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
 Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Peripheral Vascular Diseases