RECCORD (Recording Courses of Vascular Diseases) Registry (RECCORD)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03448029 |
|
Recruitment Status :
Recruiting
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |
| Group/Cohort |
|---|
|
Endovascular Patients
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
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: Marco Tränkle | 0049-761-4589480 | info@reccord.de | |
| Contact: Marcus Treitl, Prof. |
| 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. | |
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 |