Aneurysm CerebralNCT07420179
Derivo 2 Heal vs Derivo 2: In-Stent Stenosis After Flow Diversion
A study testing Coated Flow Diverter and Uncoated Flow Diverter in people with Aneurysm Cerebral, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
The goal of this clinical trial is to learn whether a coated flow diverter leads to fewer in-stent narrowings (in-stent stenosis) than an otherwise identical uncoated flow diverter when used to treat intracranial aneurysms in routine clinical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm Cerebral
- What is being tested?
- Coated Flow Diverter and Uncoated Flow Diverter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- 9 Sep 2021to 1 Apr 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years
- Unruptured, saccular aneurysm of the internal carotid artery (ICA) suitable for single-device flow diverter treatment
- Availability of angiographic follow-up imaging at both 3 and 9 months
Who cannot join
- Fusiform or dissecting aneurysms
- Requirement for multiple flow diverter implantation
- Previous treatment of the target aneurysm
- Contraindications to dual antiplatelet therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Derivo-ISS: A Prospective Randomized Study Comparing In-Stent Stenosis After Treatment With a Coated Versus Uncoated Flow Diverter (Derivo 2 Heal vs Derivo 2) for Intracranial ICA Aneurysms
The goal of this clinical trial is to learn whether a coated flow diverter leads to fewer in-stent narrowings (in-stent stenosis) than an otherwise identical uncoated flow diverter when used to treat intracranial aneurysms in routine clinical care. The main questions it aims to answer are:
Does the coated flow diverter reduce the rate and severity of in-stent stenosis compared with the uncoated flow diverter?
Read more
Are there differences in angiographic aneurysm occlusion and procedure-related complications between the two devices?
Researchers will compare treatment with the coated flow diverter (Derivo 2 heal) to the uncoated flow diverter (Derivo 2).
Participants will:
Receive endovascular treatment of their intracranial aneurysm with one of the two flow diverters assigned by randomization
Receive standard antiplatelet medication and follow-up imaging as part of routine care
Read the detailed description
This investigator-initiated, prospective, single-center randomized clinical study compared a surface-modified flow diverter (Derivo 2 heal; Acandis, Germany) with the corresponding uncoated device (Derivo 2) in the endovascular treatment of unruptured saccular internal carotid artery (ICA) aneurysms in routine clinical care. After confirmation of eligibility and written informed consent, patients were randomized in a 1:1 ratio to receive either the coated or uncoated flow diverter using a computer-generated permuted block randomization scheme with variable block sizes. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes prepared by an independent study coordinator. Device diameter and length were selected according to a predefined institutional sizing standard based on angiographic measurements, independent of treatment allocation.
All procedures were performed under general anesthesia via a transfemoral approach using standard technique. No adjunctive coiling and no balloon angioplasty were performed. All participants received dual antiplatelet therapy with aspirin 100 mg/day and clopidogrel 75 mg/day initiated at least 3 days before the procedure and continued for at least 12 months; platelet function testing was not routinely performed.
Angiographic follow-up was scheduled at 3 and 9 months using digital subtraction angiography (DSA). In-stent stenosis (ISS) was defined as a segmental reduction of the contrast-filled parent vessel lumen within the stented segment compared with the immediate post-procedural angiogram. Because absolute calibration is limited in 2D projection imaging, ISS severity was assessed using a standardized ratio-based approach: the vessel diameter at the site of maximal stenosis was related to a reference segment in the petrous ICA, and the resulting ratio was compared with the corresponding ratio on the immediate post-procedural angiogram to quantify relative luminal narrowing over time. For descriptive purposes, high-grade ISS (>50%) was recorded. In addition, ISS was morphologically categorized as stenosis associated with visible stent deformation (e.g., focal flattening, incomplete expansion, segmental collapse, fish-mouth configuration) versus stenosis without visible deformation, the latter interpreted as predominantly related to intimal hyperplasia.
Aneurysm occlusion was assessed on follow-up DSA using the O'Kelly-Marotta (OKM) grading scale. Complete occlusion was predefined as OKM grade D (no residual aneurysm filling). Clinical events and adverse events were prospectively recorded during the periprocedural period and follow-up visits.
The primary objective was to compare the incidence and severity of ISS between the coated and uncoated flow diverter groups over time. Secondary objectives included comparison of aneurysm occlusion rates and evaluation of relationships between angiographic outcomes and device- or vessel-related factors.
- Conditions
- Aneurysm Cerebral
- Being tested
- Coated Flow Diverter, Uncoated Flow Diverter
- Keywords
- Aneurysm, Flow Diverter, In-Stent-Stenosis
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coated Flow DiverterDevice
A surface-modified intracranial flow diverter stent with an anti-thrombogenic coating (Derivo 2 heal, Acandis, Germany) used for endovascular treatment of unruptured intracranial internal carotid artery aneurysms. Device diameter and length are selected individually based on angiographic measurements according to institutional routine practice.
Uncoated Flow DiverterDevice
The corresponding uncoated intracranial flow diverter stent (Derivo 2, Acandis, Germany) used for endovascular treatment of unruptured intracranial internal carotid artery aneurysms. Device diameter and length are selected individually based on angiographic measurements according to institutional routine practice.
| Study group | Role | What they receive |
|---|---|---|
| Coated Flow Diverter (Derivo 2 heal) | Experimental | Participants receive endovascular treatment of an unruptured intracranial internal carotid artery aneurysm using the coated flow diverter (Derivo 2 heal). Device diameter and length are selected individually based on angiographic measurements according to institutional routine practice. Periprocedural care and follow-up imaging are performed as part of standard care. Receives: Device: Coated Flow Diverter |
| Uncoated Flow Diverter (Derivo 2) | Active comparator | Participants receive endovascular treatment of an unruptured intracranial internal carotid artery aneurysm using the uncoated flow diverter (Derivo 2). Device diameter and length are selected individually based on angiographic measurements according to institutional routine practice. Periprocedural care and follow-up imaging are performed as part of standard care. Receives: Device: Uncoated Flow Diverter |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-Stent Stenosis Severity (Ratio-Based Luminal Narrowing)
In-stent stenosis (ISS) quantified on follow-up digital subtraction angiography (DSA) using a standardized ratio-based approach: the diameter at maximal stenosis within the stented segment relative to a reference segment (petrous ICA), compared with the corresponding ratio on the immediate post-procedural angiogram to derive relative luminal narrowing over time. Higher values indicate greater luminal narrowing (ISS severity).
Measured: 3 months and 9 months after the procedure (DSA follow-up)
Secondary outcomes (3)
High-Grade In-Stent Stenosis (>50%)
Proportion of participants with high-grade in-stent stenosis defined as >50% luminal narrowing within the stented segment on follow-up DSA.
Measured: 3 months and 9 months after the procedure
Complete Aneurysm Occlusion (OKM Grade D)
Complete angiographic occlusion on follow-up DSA defined as O'Kelly-Marotta (OKM) grade D (no residual aneurysm filling).
Measured: 3 months and 9 months after the procedure
Procedure-Related Complications
Occurrence of periprocedural complications related to the endovascular treatment (e.g., thromboembolic events, hemorrhagic complications, device-related adverse events) recorded prospectively.
Measured: Periprocedural period through 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start9 Sep 2021
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aneurysm CerebralStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Umut Yilmaz, Universität des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420179
- Sponsor's protocol ID
- 90/21
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to local data protection regulations and because participant consent did not include public sharing of individual-level clinical and imaging data. Aggregated results will be reported in publications.
Publications
Garner M, Fries F, Haussmann A, Kettner M, Bachhuber A, Reith W, Yilmaz U. Recurrent reversible in-stent-stenosis after flow diverter treatment. Neuroradiology. 2023 Jul;65(7):1173-1177. doi: 10.1007/s00234-023-03144-7. Epub 2023 Mar 28.
PubMed 36973452Muhl-Benninghaus R, Haussmann A, Simgen A, Tomori T, Reith W, Yilmaz U. Transient in-stent stenosis: a common finding after flow diverter implantation. J Neurointerv Surg. 2019 Feb;11(2):196-199. doi: 10.1136/neurintsurg-2018-013975. Epub 2018 Jul 3.
PubMed 29970620
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Derivo-ISS: A Prospective Randomized Study Comparing In-Stent Stenosis After Treatment With a Coated Versus Uncoated Flow Diverter (Derivo 2 Heal vs Derivo 2) for Intracranial ICA Aneurysms
- ClinicalTrials.gov ID
- NCT07420179
- Acronym / sponsor ID
- 90/21
- Conditions
- Aneurysm Cerebral
- Keywords
- Aneurysm, Flow Diverter, In-Stent-Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 19 Feb 2026 (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 goal of this clinical trial is to learn whether a coated flow diverter leads to fewer in-stent narrowings (in-stent stenosis) than an otherwise identical uncoated flow diverter when used to treat intracranial aneurysms in routine clinical care. The main questions it aims to answer are:
Does the coated flow diverter reduce the rate and severity of in-stent stenosis compared with the uncoated flow diverter?
Are there differences in angiographic aneurysm occlusion and procedure-related complications between the two devices?
Researchers will compare treatment with the coated flow diverter (Derivo 2 heal) to the uncoated flow diverter (Derivo 2).
Participants will:
Receive endovascular treatment of their intracranial aneurysm with one of the two flow diverters assigned by randomization
Receive standard antiplatelet medication and follow-up imaging as part of routine care
Detailed description
This investigator-initiated, prospective, single-center randomized clinical study compared a surface-modified flow diverter (Derivo 2 heal; Acandis, Germany) with the corresponding uncoated device (Derivo 2) in the endovascular treatment of unruptured saccular internal carotid artery (ICA) aneurysms in routine clinical care. After confirmation of eligibility and written informed consent, patients were randomized in a 1:1 ratio to receive either the coated or uncoated flow diverter using a computer-generated permuted block randomization scheme with variable block sizes. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes prepared by an independent study coordinator. Device diameter and length were selected according to a predefined institutional sizing standard based on angiographic measurements, independent of treatment allocation.
All procedures were performed under general anesthesia via a transfemoral approach using standard technique. No adjunctive coiling and no balloon angioplasty were performed. All participants received dual antiplatelet therapy with aspirin 100 mg/day and clopidogrel 75 mg/day initiated at least 3 days before the procedure and continued for at least 12 months; platelet function testing was not routinely performed.
Angiographic follow-up was scheduled at 3 and 9 months using digital subtraction angiography (DSA). In-stent stenosis (ISS) was defined as a segmental reduction of the contrast-filled parent vessel lumen within the stented segment compared with the immediate post-procedural angiogram. Because absolute calibration is limited in 2D projection imaging, ISS severity was assessed using a standardized ratio-based approach: the vessel diameter at the site of maximal stenosis was related to a reference segment in the petrous ICA, and the resulting ratio was compared with the corresponding ratio on the immediate post-procedural angiogram to quantify relative luminal narrowing over time. For descriptive purposes, high-grade ISS (>50%) was recorded. In addition, ISS was morphologically categorized as stenosis associated with visible stent deformation (e.g., focal flattening, incomplete expansion, segmental collapse, fish-mouth configuration) versus stenosis without visible deformation, the latter interpreted as predominantly related to intimal hyperplasia.
Aneurysm occlusion was assessed on follow-up DSA using the O'Kelly-Marotta (OKM) grading scale. Complete occlusion was predefined as OKM grade D (no residual aneurysm filling). Clinical events and adverse events were prospectively recorded during the periprocedural period and follow-up visits.
The primary objective was to compare the incidence and severity of ISS between the coated and uncoated flow diverter groups over time. Secondary objectives included comparison of aneurysm occlusion rates and evaluation of relationships between angiographic outcomes and device- or vessel-related factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coated Flow Diverter (Derivo 2 heal) | Experimental | Device: Coated Flow DiverterParticipants receive endovascular treatment of an unruptured intracranial internal carotid artery aneurysm using the coated flow diverter (Derivo 2 heal). Device diameter and length are selected individually based on angiographic measurements according to institutional routine practice. Periprocedural care and follow-up imaging are performed as part of standard care. |
| Uncoated Flow Diverter (Derivo 2) | Active comparator | Device: Uncoated Flow DiverterParticipants receive endovascular treatment of an unruptured intracranial internal carotid artery aneurysm using the uncoated flow diverter (Derivo 2). Device diameter and length are selected individually based on angiographic measurements according to institutional routine practice. Periprocedural care and follow-up imaging are performed as part of standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged ≥18 years
- Unruptured, saccular aneurysm of the internal carotid artery (ICA) suitable for single-device flow diverter treatment
- Availability of angiographic follow-up imaging at both 3 and 9 months
Key exclusion criteria (4 listed)
- Fusiform or dissecting aneurysms
- Requirement for multiple flow diverter implantation
- Previous treatment of the target aneurysm
- Contraindications to dual antiplatelet therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coated Flow DiverterA surface-modified intracranial flow diverter stent with an anti-thrombogenic coating (Derivo 2 heal, Acandis, Germany) used for endovascular treatment of unruptured intracranial internal carotid artery aneurysms. Device diameter and length are selected individually based on angiographic measurements according to institutional routine practice. | Device | Coated Flow Diverter (Derivo 2 heal) |
| Uncoated Flow DiverterThe corresponding uncoated intracranial flow diverter stent (Derivo 2, Acandis, Germany) used for endovascular treatment of unruptured intracranial internal carotid artery aneurysms. Device diameter and length are selected individually based on angiographic measurements according to institutional routine practice. | Device | Uncoated Flow Diverter (Derivo 2) |
Primary outcome
In-Stent Stenosis Severity (Ratio-Based Luminal Narrowing)
Time frame: 3 months and 9 months after the procedure (DSA follow-up)
In-stent stenosis (ISS) quantified on follow-up digital subtraction angiography (DSA) using a standardized ratio-based approach: the diameter at maximal stenosis within the stented segment relative to a reference segment (petrous ICA), compared with the corresponding ratio on the immediate post-procedural angiogram to derive relative luminal narrowing over time. Higher values indicate greater luminal narrowing (ISS severity).
3 secondary outcomes
High-Grade In-Stent Stenosis (>50%)
Time frame: 3 months and 9 months after the procedure
Complete Aneurysm Occlusion (OKM Grade D)
Time frame: 3 months and 9 months after the procedure
Procedure-Related Complications
Time frame: Periprocedural period through 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Background: PubMed 36973452Garner M, Fries F, Haussmann A, Kettner M, Bachhuber A, Reith W, Yilmaz U. Recurrent reversible in-stent-stenosis after flow diverter treatment. Neuroradiology. 2023 Jul;65(7):1173-1177. doi: 10.1007/s00234-023-03144-7. Epub 2023 Mar 28.
- Background: PubMed 29970620Muhl-Benninghaus R, Haussmann A, Simgen A, Tomori T, Reith W, Yilmaz U. Transient in-stent stenosis: a common finding after flow diverter implantation. J Neurointerv Surg. 2019 Feb;11(2):196-199. doi: 10.1136/neurintsurg-2018-013975. Epub 2018 Jul 3.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to local data protection regulations and because participant consent did not include public sharing of individual-level clinical and imaging data. Aggregated results will be reported in publications.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coated Flow Diverter and Uncoated Flow Diverter in people with Aneurysm Cerebral, run by Universität des Saarlandes 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 19 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-Stent Stenosis Severity (Ratio-Based Luminal Narrowing) (time frame: 3 months and 9 months after the procedure (DSA follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07420179, which also lists 2 linked publications.
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 19 Feb 2026.