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Clinical outcome and Quality of Life of multimodal treatment of venous malformations of the body

Organizational Data

DRKS-ID:
DRKS00024906
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2021-07-27
Last update in DRKS:
2024-01-02
Registration type:
Prospective

Acronym/abbreviation of the study

ARTEMIS

URL of the study

http:///

Brief summary in lay language

Diagnosis of a peripheral (i.e. not located in the area of the head, but of the limbs or trunk) venous malformation (Abbreviation: VM). This vascular malformation is a rare clinical picture with very different manifestations. In addition, the symptoms also vary greatly, depending on the size and location of the AVM. Overall, there is still a great need for studies on such congenital vascular malformations in order to generate further and reliable findings on the optimal long-term treatment of this rare disease.

Brief summary in scientific language

The study objective is to determine the effectiveness, safety and clinical outcome including health-related Quality of Life of multimodal treatment of venous malformations. Therapy options include conservative management, medical treatment, minimally-invasive image-guided therapy (sclerotherapy) and surgery as well as combinations of all of the above. Of note, especially image-guided therapy routinely requires multiple therapy sessions. Clinical outcome shall therefore be assessed before initiation of treatment, during therapy (including in between multiple therapy sessions) as well as at defined time points after therapy of the VM.

Health condition or problem studied

ICD10:
Q27.8 - Other specified congenital malformations of peripheral vascular system
ICD10:
Q74.8 - Other specified congenital malformations of limb(s)
ICD10:
Q87 - Other specified congenital malformation syndromes affecting multiple systems
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Peripheral (i.e. not in the region of the head but on the limbs or trunk) venous malformation has been diagnosed (abbreviated VM). This vascular malformation is a rare clinical picture with very different manifestations. In addition, the symptoms also vary greatly, depending on the size and location of the VM. The patient is admitted to the hospital, is physically examined and prepared according to the clinical standard for the therapy planned for the next day. After the therapy (e.g. sclerotherapy), the patient remains inpatient for 2-3 days and comes either for further therapy sessions at certain intervals (re-evaluation/follow-up at each cycle, as well as fixed after 6 months after therapy initiation) or directly afterwards for follow-up examinations after 6, 12, 24, 36 months after therapy completion.

Endpoints

Primary outcome:
Patient-reported health-related Quality of Life in a multimodal therapy concept for venous malformation treatment at 6 months after completion of invasive treatment. In order to investigate the QoL in a standardized way, established questionnaires (SF-36v2, SF-10) will be used.
Secondary outcome:
Therapeutic efficiency and clinical outcome of the selected therapeutic concept for venous malformation treatment at 12, 24, 36 months after completion of invasive treatment: - Physician-reported signs: general appearance (for example swelling, pulsation, pain, thrombosis, coagulopathy, cardiovascular health issues, bleeding) and location-specific signs (for example extremity length discrepancy, physical impairment) - Radiological assessment

Study Design

Purpose:
Prognosis
Allocation:
N/A (single arm study)
Control:
  • Uncontrolled/single arm
Phase:
I
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Single (group)
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Austria
  • Germany
  • Switzerland
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Klinik für Radiologie und Nuklearmedizin Basel
  • Medical center Kinderchirurgie / Zentrum für Vaskuläre Malformationen Klinikums Barnim GmbH Eberswald Eberswalde
  • University medical center Gefäßchirurgische Abteilung und Radiologisches Institut Erlangen
  • University medical center Klinik und Poliklinik für Radiologie München
  • University medical center Halle Saale
  • University medical center Institut für Klinische Radiologie und Nuklearmedizin Mannheim
  • University medical center Institut für Klinische Radiologie Münster
  • University medical center Klinik für diagnostische und interventionelle Radiologie und Klinik für Pädiatrische Hämatologie und Onkologie Freiburg im Breisgau
  • University medical center HNO-Klinik und Klinik für Röntgendiagnostik Regensburg
  • Medical center Zürich
  • Medical center Bern
  • Medical center Salzburg

Recruitment period and number of participants

Planned study start date:
2021-08-17
Actual study start date:
2021-10-13
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
300
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
4 Years
Maximum Age:
70 Years
Additional Inclusion Criteria:
Age: > 4 years, < 70 years - Patients with simple peripheral (=extracranial) venous malformations according to the ISSVA (International Society for the Study of Vascular Anomalies) classification. Each patient and the corresponding diagnosis, is discussed in an interdisciplinary board for vascular anomalies before initiation of treatment. Patients with combined vascular malformations and venous malformations associated with other anomalies according to the ISSVA (International Society for the Study of Vascular Anomalies) classification - Patients with first line therapy or patients with previous alternative therapies in whom the previous treatments did not lead to durable symptom improvement - Previous surgery or sclerotherapy are not an exclusion criterion, but these patients will only be included in case of a therapy-free interval of 12 months - Adults and children will be similarly included

Exclusion Criteria

Patients with VM located in the central nervous system - Patients with VM located in abdominal parenchymal organs and the gastrointestinal tract - Patients with other high-flow vascular anomalies (e. g. vascular tumors) - Patients who have been previously treated by surgery or sclerotherapy within the last 12 months - Patients with concomitant life-limiting diseases (such as cancer) - Patients with acute inflammatory diseases - Patients with contraindications for invasive treatments o Patients with contrast agent intolerance or renal insufficiency (GFR>30ml/min) o Patients with impaired coagulation status:- Platelet count <50.000 / μl - aPTT > 50s - INR > 1,5 o Poor general condition with ECOC performance > 1 - Pregnant or breast-feeding women - Inability to access the VM lesion due to anatomical or pathoanatomical reason - Inability of the patient/parents to understand or follow the study protocol e.g. due to impaired mental health status - Patients/parents who refuse to give informed consent

Addresses

Primary Sponsor

Klinikum der Universität München, Campus Großhadern
Marchioninistraße 15
81377 München
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.klinikum.uni-muenchen.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinikum der Universität München
Prof. Dr. med. Moritz Wildgruber
Marchioninistr. 15
81377 München
Germany
Telephone:
+49 89 4400-76642
Fax:
(089) 4400-44468
Contact per E-Mail
URL:
http://www.klinikum.uni-muenchen.de/de/index.html

Contact for Public Queries

Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
Dr. Vanessa F. Schmidt
Marchioninistr. 15
81377 München
Germany
Telephone:
+49-89-440044462
Fax:
+49-89-440044468
Contact per E-Mail
URL:
http://radiologie.klinikum.uni-muenchen.de/de/

Principal Investigator

Klinikum der Universität München
Prof. Dr. med. Moritz Wildgruber
Marchioninistr. 15
81377 München
Germany
Telephone:
+49 89 4400-76642
Fax:
(089) 4400-44468
Contact per E-Mail
URL:
http://www.klinikum.uni-muenchen.de/de/index.html

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
Marchioninistr. 15
81377 München
Germany
Telephone:
(089) 4400-4400 72750
Fax:
(089) 4400-76648
Contact per E-Mail
URL:
http://www.klinikum.uni-muenchen.de/de/index.html

Ethics Committee

Address Ethics Committee

Ethikkommission der Med. Fakultät der LMU
Pettenkoferstraße 8
80336 München
Germany
Telephone:
+49-89-440055191
Fax:
+49-89-440055192
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2021-03-31
Ethics committee number:
21-0545
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-06-30

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
Other secondary IDs:
LMU-RAD00732 - interne Studien-ID
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
The data is anonymized in accordance with data protection legislation. Personal data cannot be traced.

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry