Aneurysm AbdominalDEDICATENCT06325371
Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2
An observational study of Aneurysm Abdominal and Arterial Aneurysm, run by University of Turin, Italy at 1 site in Italy.
Trial summary
This is a multicentric voluntary observational study with a retrospective evaluation of prospectively collected data concerning the treatment of visceral aneurysms with flow diversion stent Derivo Peripher and Derivo 2 (DED, Acandis GmbH) Follow-up will include clinical and radiological (CT) evaluation at least 12… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm Abdominal, Arterial Aneurysm
- What is being tested?
- Visceral aneurysm stenting
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 20 Nov 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Men and women >18 years old with the presence of a visceral aneurysm.
Who may be able to join
- >18 years old
- Visceral artery aneurysms, evaluated with computed tomography angiography-CTA- withindication for treatment according to 2020 SVS and 2024 SICVE/SIRM and 2024 CIRSE guidelines. Specifically:
- Renal artery: >2 cm if fusiform morphology or all dimensions if sacculary or bifurcation morphology, if in fertile women or in hypertensive patients with renal stenosis
- Splenic artery: if >2 cm, or all dimensions in fertile women.
- Celiac tripod: if >2 cm.
- Hepatic artery: if >2 cm or growth greater than 0.5 cm/year.
Show all 14Show fewer
- Superior mesenteric artery, gastric or gastroepiploic artery, pancreaticoduodenal or gastroduodenal arteries, colic arteries, jejunal arteries, and ileal arteries: any size
- anatomical characteristics compatible with the stent DED Instruction for Use (IFU). Specifically:
- the stent diameter should match the largest diameter of either the proximal or distal vessel of the aneurysm with an oversizing of 1-2 mm according to IFU.
- the stent length must allow for adequate proximal and distal landing, covering the neck of the aneurysm to 2.5 times the vessel's internal diameter and no less than 15 mm.
- proper adherence to the anticoagulant and antiplatelet pharmacological protocol for the peri-procedural and post-procedural periods. Specifically:
- all patients should begin dual antiplatelet therapy (DAPT) before surgery (for at least 3 days before the procedure or with a loading dose pre-procedurally).
- all patients receive systemic anticoagulation during the procedure (Heparin 70 IU/kg to achieve an Activated Clot Time (ACT) > 250 s).
- after the procedure, the patient should continue DAPT (e.g., ASA 100 mg daily and Clopidogrel 75 mg daily) for at least 1 month, then continue with single antiplatelet therapy (e.g., ASA 100 mg) indefinitely.
Who cannot join
- patients who are hemodynamically unstable or show CT signs of rupture or contained rupture of visceral aneurysm
- pregnant or breastfeeding women
- life expectancy less than 2 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
AOU Città della Salute e della Scienza di Torino
Torino, TO, 10126
Marco Prof. Calandri, MD, +390116336311, marco.calandri@unito.it
Andrea Dott. Discalzi, MD
About this study
This is a multicentric voluntary observational study with a retrospective evaluation of prospectively collected data concerning the treatment of visceral aneurysms with flow diversion stent Derivo Peripher and Derivo 2 (DED, Acandis GmbH) Follow-up will include clinical and radiological (CT) evaluation at least 12 months after the intervention.
The enrollment period will be of 65 months (01/jan/2020-30/jun/2025). Sample size will be of 100 patients.
- Conditions
- Aneurysm Abdominal, Arterial Aneurysm
- Being tested
- Visceral aneurysm stenting
- Keywords
- flow diverter, visceral aneurysm, stenting
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visceral aneurysm stentingDevice
Also called stent
Flow diverter stenting
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the stenting in terms of patency and side branches
stent patency and side branches (the absence of stenosis greater than 50% of the stent's internal lumen and the side branches' lumen)
Measured: 12 months
Efficacy of the stenting in terms of aneurysm thrombosis rate
aneurysm (partial or complete, >50% or 100%) thrombosis
Measured: 12 months
Efficacy of the stenting in terms of aneurysm volume assessment
aneurysm volume assessment (percentage of volume reduction respect to the initial volume)
Measured: 12 months
Safety in terms of morbidity
morbidity (any adverse events occured during follow up for any causes and by causes associated with treatment)
Measured: 12 months
Safety in terms of mortality
mortality (any cause of death related to pathology or not)
Measured: 12 months
Safety in terms of technical issues
technical issues (any adverse event during stent placement)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start20 Nov 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aneurysm AbdominalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Calandri, M.D., Principal investigator, University of Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325371
- Sponsor's protocol ID
- 0028201
- Acronym
- DEDICATE
- Status last verified
- Feb 2025
- First submitted
- 5 Mar 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD will be shared to other researchers
Publications
Discalzi A, Nardelli F, Ficara B, Comelli S, de Donato G, Fanelli F, Quaretti P, Sallemi C, Semeraro V, Sirovich R, Calandri M; DEDICATE Investigators. Study Protocol DEDICATE: Italian Multicenter Study on the Treatment of Visceral Aneurysms with the Derivo Peripher and Derivo 2 Flow Diverter Stent. Cardiovasc Intervent Radiol. 2025 May;48(5):694-701. doi: 10.1007/s00270-025-04016-8. Epub 2025 Mar 13.
PubMed 40082273
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2
- ClinicalTrials.gov ID
- NCT06325371
- Acronym / sponsor ID
- DEDICATE / 0028201
- Conditions
- Aneurysm Abdominal, Arterial Aneurysm
- Keywords
- flow diverter, visceral aneurysm, stenting
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Mar 2024 (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.
This is a multicentric voluntary observational study with a retrospective evaluation of prospectively collected data concerning the treatment of visceral aneurysms with flow diversion stent Derivo Peripher and Derivo 2 (DED, Acandis GmbH) Follow-up will include clinical and radiological (CT) evaluation at least 12 months after the intervention.
The enrollment period will be of 65 months (01/jan/2020-30/jun/2025). Sample size will be of 100 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women >18 years old with the presence of a visceral aneurysm.
Key inclusion criteria (14 listed)
- >18 years old
- Visceral artery aneurysms, evaluated with computed tomography angiography-CTA- withindication for treatment according to 2020 SVS and 2024 SICVE/SIRM and 2024 CIRSE guidelines. Specifically:
- anatomical characteristics compatible with the stent DED Instruction for Use (IFU). Specifically:
- proper adherence to the anticoagulant and antiplatelet pharmacological protocol for the peri-procedural and post-procedural periods. Specifically:
Key exclusion criteria (3 listed)
- patients who are hemodynamically unstable or show CT signs of rupture or contained rupture of visceral aneurysm
- pregnant or breastfeeding women
- life expectancy less than 2 years
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 |
|---|---|---|
| Visceral aneurysm stentingAlso: stentFlow diverter stenting | Device | – |
Primary outcome
Efficacy of the stenting in terms of patency and side branches
Time frame: 12 months
stent patency and side branches (the absence of stenosis greater than 50% of the stent's internal lumen and the side branches' lumen)
Efficacy of the stenting in terms of aneurysm thrombosis rate
Time frame: 12 months
aneurysm (partial or complete, >50% or 100%) thrombosis
Efficacy of the stenting in terms of aneurysm volume assessment
Time frame: 12 months
aneurysm volume assessment (percentage of volume reduction respect to the initial volume)
Safety in terms of morbidity
Time frame: 12 months
morbidity (any adverse events occured during follow up for any causes and by causes associated with treatment)
Safety in terms of mortality
Time frame: 12 months
mortality (any cause of death related to pathology or not)
Safety in terms of technical issues
Time frame: 12 months
technical issues (any adverse event during stent placement)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Derived from this study: PubMed 40082273Discalzi A, Nardelli F, Ficara B, Comelli S, de Donato G, Fanelli F, Quaretti P, Sallemi C, Semeraro V, Sirovich R, Calandri M; DEDICATE Investigators. Study Protocol DEDICATE: Italian Multicenter Study on the Treatment of Visceral Aneurysms with the Derivo Peripher and Derivo 2 Flow Diverter Stent. Cardiovasc Intervent Radiol. 2025 May;48(5):694-701. doi: 10.1007/s00270-025-04016-8. Epub 2025 Mar 13.
- Individual participant dataSharing planned: No. No IPD will be shared to other researchers
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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.
Marco Calandri, M.D. principal investigator
University of Torino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm Abdominal and Arterial Aneurysm, run by University of Turin, Italy at 1 site in Italy.
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 14 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Feb 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Discalzi, M.D. (390116336311, adiscalzi@cittadellasalute.to.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the stenting in terms of patency and side branches (time frame: 12 months). The study lists 6 primary outcomes in all. 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 NCT06325371, which also lists 1 linked publication.
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 18 Feb 2025.