Clinical trial NCT03448029: RECCORD (Recording Courses of Vascular Diseases) Registry
Official title: RECCORD - Recording Courses of Vascular Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vascular Diseases
Peripheral Artery Disease
Claudication
Critical Limb Ischemia
Diabetic Foot
Keywords: Vascular Diseases
Peripheral Artery Disease
Revascularisation
Outcome
Quality Management
Registry
Endovascular Intervention
Limb Amputation
Lead sponsor: Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 6000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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

Primary outcomes:
measure: Outcome Quality after Revascularization: Complications
timeFrame: Up to 1 month
measure: Outcome Quality after Revascularization: Amputation
timeFrame: Up to 12 months
measure: Outcome Quality after Revascularization: Survival
timeFrame: Up to 12 months
measure: Quality of Life: EQ-5D-5L questionnaire
timeFrame: At baseline, at 6 and 12 months
measure: Outcome Quality after Revascularization: Re-Intervention
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinikum der Ludwig-Maximilians Universität
state: Bayern
Study officials:
References: