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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 : February 27, 2018
Sponsor:
Collaborator:
Emil GmbH
Information provided by (Responsible Party):
Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.

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 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


Group/Cohort
Endovascular Patients
Patients undergoing endovascular interventions for symptomatic PAD



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



Information from the National Library of Medicine

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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

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
Contact: Marco Tränkle 0049-761-4589480 info@reccord.de
Contact: Marcus Treitl, Prof.

Locations
Germany
Universitätsklinikum Heidelberg Not yet recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Christian Erbel, Dr.         
SRH Klinikum Karlsbad-Langensteinbach Not yet recruiting
Karlsruhe, Baden-Württemberg, Germany, 76307
Contact: Erwin Blessing, Prof.         
Klinikum Immenstadt Not yet recruiting
Immenstadt Im Allgäu, Bayern, Germany, 87509
Contact: Wulf Ito, Prof.         
Klinikum der Ludwig-Maximilians Universität Recruiting
München, Bayern, Germany, 80336
Contact: Marcus Treitl, Prof.         
Universitätsklinikum Münster Not yet recruiting
Münster, Nordrhein-Wesfalen, Germany, 48149
Contact: Mohammad Nasser Malyar, Dr.         
Evangelisches Krankenhaus Königin Elisabeth Herzberge gGmbH Recruiting
Berlin, Germany, 10365
Contact: Jens Stegemann, Dr.         
Sankt Gertrauden-Krankenhaus Recruiting
Berlin, Germany, 10713
Contact: Ralf Langhoff, Dr.         
Sponsors and Collaborators
Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.
Emil GmbH

Additional Information:
Responsible Party: Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.
ClinicalTrials.gov Identifier: NCT03448029     History of Changes
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: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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:
Ischemia
Diabetic Foot
Vascular Diseases
Peripheral Arterial Disease
Intermittent Claudication
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
Signs and Symptoms