Derivo 2 Heal vs Derivo 2: In-Stent Stenosis After Flow Diversion

NCT07420179 | Completed

• 1 other identifier: 90/21
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Aneurysm Cerebral

Keywords

Aneurysm; Flow Diverter; In-Stent-Stenosis

Outcome Measures

Primary Outcomes (1)

• 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).

  3 months and 9 months after the procedure (DSA follow-up)

Secondary Outcomes (3)

• High-Grade In-Stent Stenosis (>50%)

  3 months and 9 months after the procedure

• Complete Aneurysm Occlusion (OKM Grade D)

  3 months and 9 months after the procedure

• Procedure-Related Complications

  Periprocedural period through 9 months

Study Arms (2)

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.

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.

Device: Uncoated Flow Diverter

Interventions

Coated Flow Diverter DEVICE

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.

Coated Flow Diverter (Derivo 2 heal)

Uncoated Flow Diverter DEVICE

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.

Uncoated Flow Diverter (Derivo 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Fusiform or dissecting aneurysms
• Requirement for multiple flow diverter implantation
• Previous treatment of the target aneurysm
• Contraindications to dual antiplatelet therapy

Sponsors & Collaborators

• Universität des Saarlandes: lead

Study Sites (1)

Saarland University Hospital

Homburg, Saarland, 66421, Germany

Location

Related Publications (2)

• 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.

  PMID: 36973452 BACKGROUND

• Muhl-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.

  PMID: 29970620 BACKGROUND

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: September 9, 2021
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)