Periprocedural Vessel PerforationPREVENTNCT06394180
PeRforation EVents During ENdovascular Therapy for Acute Ischemic Stroke
An observational study of Periprocedural Vessel Perforation and Acute Ischemic Stroke, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
A large, worldwide study called PREVENT is looking at a complication that can happen during a stroke treatment called thrombectomy. This complication is a perforation of a blood vessel. The investigators aim to: 1. Find what factors make this perforation more likely. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprocedural Vessel Perforation, Acute Ischemic Stroke
- How many people
- 1,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Dec 2024to Sep 2027
- How long will I take part?
- 3 Years
- 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: Patients with and without vessel perforation perforation during thrombectomy.
Who may be able to join
- Age ≥ 18 years at time of thrombectomy
- Acute ischemic stroke with occlusion of one or several intracranial arteries and subsequent thrombectomy.
- Target cohort: Occurrence of intracranial perforation during thrombectomy with evidence of contrast extravasation in at least one diagnostic angiography series.
- Comparison cohort: No perforation during thrombectomy. Every patient in the comparison group is matched to one patient in the target population. Matching will be carried out with respect to age, gender, participating center and location of the vascular occlusion.
Who cannot join
- Presence of a documented rejection
- Presence of both ischemic stroke and intracranial hemorrhage on pre-interventional imaging.
- Patients with intracranial dissection without active contrast extravasation.
- Patients with rupture of a pre-existing intracranial aneurysm during thrombectomy.
- Patients with contrast medium extravasation into a venous space instead of free contrast medium extravasation, e.g. the cavernous sinus with consecutive development of a carotid-cavernous fistula.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Victor Schulze-Zachau, MD, +41613285632, Victor.schulze-zachau@usb.ch
Marios N Psychogios, Prof. Dr., +41613285936, Marios.psychogios@usb.ch
About this study
Official title: PeRforation EVents During ENdovascular Therapy for Acute Ischemic Stroke (PREVENT) - Registry
A large, worldwide study called PREVENT is looking at a complication that can happen during a stroke treatment called thrombectomy. This complication is a perforation of a blood vessel. The investigators aim to:
- Find what factors make this perforation more likely.
- Understand why the perforation happens by looking closely at images taken during the procedure.
- Create a simple way to classify these perforations to help doctors decide how to treat them right away.
- Improve the emergent treatment of vessel perforation to stop the bleeding rapidly.
- Provide data to guide decision whether thrombectomy should be continued or aborted after the event of vessel perforation.
- Develop a safer way to perform thrombectomy.
Investigators will compare the results collected for patients where perforation happened with those where perforation did not happen.
Read the detailed description
Stroke is the second leading cause of death and the leading cause of disability, both worldwide and in Europe. Endovascular treatment (ENT), also called thrombectomy, is a minimally invasive procedure in which the occlusion of the brain-supplying artery, which is the cause of the stroke, is recanalized by removing the obstructing blood clot using endovascular methods, i.e. via access through the vessels, and thus restoring blood flow in the affected vessel and re-establishing brain perfusion. In 2015, five randomized controlled trials showed an overwhelming benefit of thrombectomy in patients with acute ischemic stroke with large vessel occlusion of the anterior circulation with a number needed to treat as low as 2.6. Since then, the indications for thrombectomy have been expanding continuously, including patients with posterior circulation occlusions, selected patients presenting late after symptom onset and patients with large infarcts. In addition, patients with distal vessel occlusions are increasingly being considered for thrombectomy.
Despite the effectiveness of thrombectomy, the procedure has a relevant risk of periprocedural complications. In 1-2% of patients who undergo thrombectomy, a periprocedural intracranial vessel perforation occurs with subsequent arterial intracranial bleeding. This complication typically represents a major turning point and is associated with severe permanent sequelae and a mortality of approximately 50%. Given the rapidly increasing frequency of thrombectomies, an increase in the incidence of periprocedural perforations is to be expected. The available data on vascular perforations during thrombectomy are limited. It is unknown why a minority of patients experience this complication while the majority are spared. Likewise, the exact pathophysiological process that leads to vessel wall damage is not understood. There is also uncertainty as to whether extravasation in the event of vessel perforation should be treated endovascularly with intention to stop the bleeding, e.g. via temporary vessel occlusion using a balloon catheter or permanent vascular occlusion using coils or liquid embolization. In addition, there is hardly any data on whether thrombectomy attempts should continue after a perforation has occurred or whether the procedure should be aborted. Due to the low frequency of this complication, randomized prospective trials will most likely not be feasible.
In an international retrospective cohort study with 25 participating centers, the investigators were able to evaluate data from over 25,000 thrombectomies. In this cohort, 335 vessel perforations were reported. About half of the affected patients died within the first 3 months after perforation. The remaining patients experienced a clinical course that was, on average, worse than that of stroke patients without perforation in large registries. This research represents the largest cohort of patients with perforation during thrombectomy to date. It shows that although perforations are rare complications, they have enormous relevance for the affected patients.
- Keywords
- Registry, Thrombectomy Complications, Endovascular Hemostatic Therapy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Perforation during thrombectomy | The target cohort includes 500 patients where vessel perforation occured during Thrombectomy. | |
| No perforation during thrombectomy | The comparison cohort includes 500 patients, matched to the target cohort, where vessel perforation did not occur during Thrombectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS)
The mRS is a measure of patient global disability. The scale is coded from 0 (no symptoms at all) through 5 (severe disability) and 6 (death).
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start2 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionSep 2027 (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 Periprocedural Vessel PerforationStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victor Schulze-Zachau, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394180
- Sponsor's protocol ID
- 0000-00000; th23Psychogios2
- Acronym
- PREVENT
- Status last verified
- Mar 2026
- First submitted
- 26 Apr 2024
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schulze-Zachau V, Rommers N, Muenger H, Singh GK, Katan M, Balmer L, Psychogios S, Brehm A, Fischer U, Psychogios MN. PREVENT: Towards the prevention of intracranial vessel perforations during mechanical thrombectomy - protocol for a multicenter registry study. Front Neurol. 2026 Jan 23;16:1680379. doi: 10.3389/fneur.2025.1680379. eCollection 2025.
PubMed 41659979
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PeRforation EVents During ENdovascular Therapy for Acute Ischemic Stroke (PREVENT) - Registry
- ClinicalTrials.gov ID
- NCT06394180
- Acronym / sponsor ID
- PREVENT / 0000-00000; th23Psychogios2
- Keywords
- Registry, Thrombectomy Complications, Endovascular Hemostatic Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 1 May 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.
A large, worldwide study called PREVENT is looking at a complication that can happen during a stroke treatment called thrombectomy. This complication is a perforation of a blood vessel. The investigators aim to:
- Find what factors make this perforation more likely.
- Understand why the perforation happens by looking closely at images taken during the procedure.
- Create a simple way to classify these perforations to help doctors decide how to treat them right away.
- Improve the emergent treatment of vessel perforation to stop the bleeding rapidly.
- Provide data to guide decision whether thrombectomy should be continued or aborted after the event of vessel perforation.
- Develop a safer way to perform thrombectomy.
Investigators will compare the results collected for patients where perforation happened with those where perforation did not happen.
Detailed description
Stroke is the second leading cause of death and the leading cause of disability, both worldwide and in Europe. Endovascular treatment (ENT), also called thrombectomy, is a minimally invasive procedure in which the occlusion of the brain-supplying artery, which is the cause of the stroke, is recanalized by removing the obstructing blood clot using endovascular methods, i.e. via access through the vessels, and thus restoring blood flow in the affected vessel and re-establishing brain perfusion. In 2015, five randomized controlled trials showed an overwhelming benefit of thrombectomy in patients with acute ischemic stroke with large vessel occlusion of the anterior circulation with a number needed to treat as low as 2.6. Since then, the indications for thrombectomy have been expanding continuously, including patients with posterior circulation occlusions, selected patients presenting late after symptom onset and patients with large infarcts. In addition, patients with distal vessel occlusions are increasingly being considered for thrombectomy.
Despite the effectiveness of thrombectomy, the procedure has a relevant risk of periprocedural complications. In 1-2% of patients who undergo thrombectomy, a periprocedural intracranial vessel perforation occurs with subsequent arterial intracranial bleeding. This complication typically represents a major turning point and is associated with severe permanent sequelae and a mortality of approximately 50%. Given the rapidly increasing frequency of thrombectomies, an increase in the incidence of periprocedural perforations is to be expected. The available data on vascular perforations during thrombectomy are limited. It is unknown why a minority of patients experience this complication while the majority are spared. Likewise, the exact pathophysiological process that leads to vessel wall damage is not understood. There is also uncertainty as to whether extravasation in the event of vessel perforation should be treated endovascularly with intention to stop the bleeding, e.g. via temporary vessel occlusion using a balloon catheter or permanent vascular occlusion using coils or liquid embolization. In addition, there is hardly any data on whether thrombectomy attempts should continue after a perforation has occurred or whether the procedure should be aborted. Due to the low frequency of this complication, randomized prospective trials will most likely not be feasible.
In an international retrospective cohort study with 25 participating centers, the investigators were able to evaluate data from over 25,000 thrombectomies. In this cohort, 335 vessel perforations were reported. About half of the affected patients died within the first 3 months after perforation. The remaining patients experienced a clinical course that was, on average, worse than that of stroke patients without perforation in large registries. This research represents the largest cohort of patients with perforation during thrombectomy to date. It shows that although perforations are rare complications, they have enormous relevance for the affected patients.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perforation during thrombectomy | – | –The target cohort includes 500 patients where vessel perforation occured during Thrombectomy. |
| No perforation during thrombectomy | – | –The comparison cohort includes 500 patients, matched to the target cohort, where vessel perforation did not occur during Thrombectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with and without vessel perforation perforation during thrombectomy.
Key inclusion criteria (4 listed)
- Age ≥ 18 years at time of thrombectomy
- Acute ischemic stroke with occlusion of one or several intracranial arteries and subsequent thrombectomy.
- Target cohort: Occurrence of intracranial perforation during thrombectomy with evidence of contrast extravasation in at least one diagnostic angiography series.
- Comparison cohort: No perforation during thrombectomy. Every patient in the comparison group is matched to one patient in the target population. Matching will be carried out with respect to age, gender, participating center and location of the vascular occlusion.
Key exclusion criteria (5 listed)
- Presence of a documented rejection
- Presence of both ischemic stroke and intracranial hemorrhage on pre-interventional imaging.
- Patients with intracranial dissection without active contrast extravasation.
- Patients with rupture of a pre-existing intracranial aneurysm during thrombectomy.
- Patients with contrast medium extravasation into a venous space instead of free contrast medium extravasation, e.g. the cavernous sinus with consecutive development of a carotid-cavernous fistula.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Rankin Scale (mRS)
Time frame: 90 days
The mRS is a measure of patient global disability. The scale is coded from 0 (no symptoms at all) through 5 (severe disability) and 6 (death).
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 9 Mar 2026.
- Derived from this study: PubMed 41659979Schulze-Zachau V, Rommers N, Muenger H, Singh GK, Katan M, Balmer L, Psychogios S, Brehm A, Fischer U, Psychogios MN. PREVENT: Towards the prevention of intracranial vessel perforations during mechanical thrombectomy - protocol for a multicenter registry study. Front Neurol. 2026 Jan 23;16:1680379. doi: 10.3389/fneur.2025.1680379. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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.
Victor Schulze-Zachau, MD principal investigator
University Hospital, Basel, Switzerland
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 Periprocedural Vessel Perforation and Acute Ischemic Stroke, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 4 inclusion and 5 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 9 Mar 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 Switzerland. 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 Victor Schulze-Zachau, MD (+41 61 328 56 32, Victor.schulze-zachau@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) (time frame: 90 days). 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 NCT06394180, 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 9 Mar 2026.