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DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device

ConditionsIntracranial AneurysmFlow Diverter
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcandis GmbH

About this trial

To analyse the clinical safety and efficacy of the DERIVO® 2heal® Embolisation Device in the standard clinical routine of flow diversion treatment with respect to the mid- and long-term clinical and angiographic outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient to be treated with DERIVO® 2heal® Embolisation Device due to intracranial aneurysm according to IFU

Age > 18 years

Signed Informed Consent Form

Patient scheduled to be treated for only one target aneurysm except multiple aneurysms located in the same target zone to be treated with one DERIVO® 2heal® Embolisation Device

Disqualifiers

Previously treated aneurysms with flow diverter, stent or WEB device

Treatment as preparation for the flow-diversion treatment does not lead to exclusion of the patient

Patient with a ruptured aneurysm in the acute phase of bleeding

Pre-treatment disability (mRS > 2)

Trial population

All patients who were selected for flow diversion therapy and will be treated with DERIVO® 2heal® Embolisation Device due to intracranial aneurysm according to clinical routine.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Flow Diverter Treatment with DERIVO 2 Heal Embolisation Device

    Device

    Flow diversion therapy fpr intracranial aneurysm treatment.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Primary efficacy endpoint

• Rate of complete aneurysm occlusion

Time frame
6 weeks +/- 3weeks; 6months +/- 3 months; 12months +/-3months
2

Primary safety endpoint

* Stroke/Death Occurrence Percentage of subjects with major stroke in the territory of treated artery or neurological death post-procedure * Rate of device-related \& procedure-related complications (e.g. ICH, in-stent stenosis, in-stent thrombosis)

Time frame
12month ± 3month
3

Primary clinical endpoint

• Good Clinical outcome

Time frame
6 weeks ± 3weeks; 6months ± 3 months; 12months ± 3months

Secondary outcomes

1

Secondary efficacy endpoint

* Wall apposition of the flow-diverter(s) per patient as determined by the treating physician and the core-lab after treatment. 1. Correct wall apposition in the parent vessel 2. Gap between FD and vessel wall \< 25 % of vessel diameter 3. Gap between FD and vessel wall \>25 % of vessel diameter * Stasis / flow changes in the aneurysm (O´Kelly Marotta Scale/Kamran grading scale)

Time frame
Measured directly after treatment
2

Secondary safety endpoint

• Rate of participants (%) with significant parent artery stenosis (\> 50%) or retreatment of the target aneurysm post-procedure

Time frame
12months ± 3months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Acandis GmbH

Lead sponsor

Source ClinicalTrials.gov
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