Vascular DiseasesRECCORDNCT03448029
RECCORD (Recording Courses of Vascular Diseases) Registry
An observational study of Vascular Diseases and Peripheral Artery Disease, run by Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V. at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Diseases, Peripheral Artery Disease, Claudication
- How many people
- 6,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2018to 31 Dec 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- any type of endovascular interventions for symptomatic PAD
- endovascular intervention for PAD of lower extremities, i.e. below the aorto-iliac bifurcation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Nasser Malyar, Dr. contact
Germany1 site, 1 recruiting
- Recruiting
Klinikum der Ludwig-Maximilians Universität
München, Bavaria, 80336
Ulrich Hoffmann, Prof.
About this study
Official title: RECCORD - Recording Courses of Vascular Diseases
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.
Read more
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
Read the 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
- 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
- Medical subject headings
- Vascular Diseases, Peripheral Arterial Disease, Intermittent Claudication, Chronic Limb-Threatening Ischemia, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Patients | Patients undergoing endovascular interventions for symptomatic PAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Quality after Revascularization: Complications
Peri- and post-interventional complications (puncture-site complications \& intervention-related complications over 30 days
Measured: Up to 1 month
Outcome Quality after Revascularization: Amputation
Amputation-free survival (AFS)
Measured: Up to 12 months
Outcome Quality after Revascularization: Survival
Survival at one year in CLI patients
Measured: 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
Measured: At baseline, at 6 and 12 months
Outcome Quality after Revascularization: Re-Intervention
Number of re-interventions
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448029
- Sponsor's protocol ID
- RECCORD
- Other IDs
- DRKS00013585, U1111-1209-6562
- Acronym
- RECCORD
- Status last verified
- Jan 2021
- First submitted
- 8 Feb 2018
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECCORD - Recording Courses of Vascular Diseases
- ClinicalTrials.gov ID
- NCT03448029
- Acronym / sponsor ID
- RECCORD / RECCORD
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.University, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular Patients | – | –Patients undergoing endovascular interventions for symptomatic PAD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- any type of endovascular interventions for symptomatic PAD
- endovascular intervention for PAD of lower extremities, i.e. below the aorto-iliac bifurcation
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Official RECCORD HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasser Malyar, Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Diseases and Peripheral Artery Disease, run by Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulrich Hoffmann, Prof. (0049-30-20888831, info@reccord.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome Quality after Revascularization: Complications (time frame: Up to 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.