Trial · NCT02509468
suPERficial Slow-flow Vascular malFORMations Treated With sirolimUS
NCT02509468, Phase 2, Completed, University Hospital, Tours
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. suPERficial Slow-flow Vascular malFORMations Treated With sirolimUS. Trials, record NCT02509468. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02509468
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- suPERficial Slow-flow Vascular malFORMations Treated With sirolimUS
- NCT number
- NCT02509468
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- University Hospital, Tours
- Conditions
- Vascular Malformation
- Interventions
- Sirolimus
- First posted
- 2015-07-28
- Last updated
- 2025-12-22
- Other registries' IDs
- eudract:2015-001096-43
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of volume of the Vascular Malformation | at baseline, at date of switch from the observational period to the sirolimus period (between 4 and 8 month) and at 12 months | Primary outcome will be based on the volume of the VMs on MRI. Three MRI will be performed: one at baseline (M0), one at the date of switch from the observational period to the sirolimus period (MS) and one at the end of follow-up (M12). Relative change of volume, standardized by the duration period, will define the outcome. Thus, for the observational period, the primary outcome is defined as {(VMS - V0)/V0}/(MS-M0) where V0 and VMS are the volumes assessed at baseline and month S, respectively, and (MS-M0) corresponds to the duration of the observational period. For the sirolimus period, the outcome is defined in the same way as {(V12 - VMS)/VMS}/(M12-MS), where V12 is the volume assessed at month 12 and (M12-MS) corresponds to the duration of the sirolimus period. Interpretation of the MRI will be centralized and performed by a radiologist blinded from physical assessment and from treatment period. |
| Secondary | Efficacy of study treatment measured on digital photographs | inclusion, switch from the observational period to the sirolimus period (between 4 and 8 month), switch+1month, 12 month | Qualitative assessment of efficacy on digital photographs |
| Secondary | Self assessment of efficacy of study treatment | Participants will be followed during 12 months | Patient self assessment or proxy (parents) self assessments using visual analogic scale (0-10): * Global treatment efficacy on a visual analogic scale (0-10) * Skin complications/symptoms (seepage, bleeding, skin tension, functional impairment) * Pain * Quality of life by the dermatological quality of life scale (DLQI and DLQI adapted to children) |
| Secondary | Dermatologist's assessment of efficacy of study treatment | Participants will be followed during 12 months | Dermatologist's global assessment of efficacy using a visual analogic scale (0-10) |
| Secondary | Efficacy of study treatment | Participants will be followed during 12 months | Decrease of vascular endothelium growth factor (VEGF) and Tissue Factor (TF) plasma levels Platelet count, and fibrinogen, D-dimers, factor V levels supporting the presence and disappearance of an abnormal intravascular coagulation consumption |
| Secondary | Adverse events and safe adverse events will be compared | Participants will be followed during 12 months | Adverse events and safe adverse events will be compared using the Mc Nemar test, if applicable. Otherwise, descriptive statistics (percentages) will be estimated. |
| Secondary | Organic collection of skin and blood samples | at 5 month or 6 month or 7 month or 8 month or 9 month after inclusion | From the organic collection (including blood and skin samples), genetic analysis of several genes involved in vasculogenesis (currently TIE2 and PIK3CA) will be performed. A genotype/phenotype study will be carried out. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02509468
GET https://conductscience.org/api/trials/v1/NCT02509468/registered