An observational study in Vascular Diseases, Peripheral Artery Disease and Claudication, sponsored by Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.. Status unknown at 1 site in Germany. Per ClinicalTrials.gov, last updated 2021-02-05.
Sponsored by Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V. · Observational
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
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
694 studies on the registry are indexed under Vascular Diseases; 128 are open to participants now.
This study's planned enrollment of 6,000 is above the median of 200 across 218 observational studies indexed under Vascular Diseases.
Browse Vascular Diseases studies →This is the only study on the registry with Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing endovascular interventions for symptomatic PAD
Outcome Quality after Revascularization: Complications
Peri- and post-interventional complications (puncture-site complications \& intervention-related complications over 30 days
Time frame: Up to 1 month
Outcome Quality after Revascularization: Amputation
Amputation-free survival (AFS)
Time frame: Up to 12 months
Outcome Quality after Revascularization: Survival
Survival at one year in CLI patients
Time frame: 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
Time frame: At baseline, at 6 and 12 months
Outcome Quality after Revascularization: Re-Intervention
Number of re-interventions
Time frame: Up to 12 months
Plan to share: Yes
Started Jan 2018 (actual). Primary completion is estimated for Dec 2023, 71 months after the start.
Of 75 non-industry observational studies under Vascular Diseases, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 167. This study's planned 71 months is close to that.
Counting every sponsor, half of 100 studies reached it within 52 months; a quarter within 25 and three quarters within 128.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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