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
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|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||6000 participants|
|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|
Patients undergoing endovascular interventions for symptomatic PAD
- 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
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
|Contact: Ulrich Hoffmann, Prof.||email@example.com|
|Contact: Nasser Malyar, Dr.|
|Klinikum der Ludwig-Maximilians Universität||Recruiting|
|München, Bayern, Germany, 80336|
|Contact: Ulrich Hoffmann, Prof.|