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RecruitingNCT06394180PREVENTUpdated Mar 9, 2026

PeRforation EVents During ENdovascular Therapy for Acute Ischemic Stroke

An observational study in Periprocedural Vessel Perforation and Acute Ischemic Stroke, sponsored by University Hospital, Basel, Switzerland. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-09.

Sponsored by University Hospital, Basel, Switzerland · Observational

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 10 months later.
Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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. Understand why the perforation happens by looking closely at images taken during the procedure.
  3. Create a simple way to classify these perforations to help doctors decide how to treat them right away.
  4. Improve the emergent treatment of vessel perforation to stop the bleeding rapidly.
  5. Provide data to guide decision whether thrombectomy should be continued or aborted after the event of vessel perforation.
  6. 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.

02

Conditions studied

  • Periprocedural Vessel Perforation
  • Acute Ischemic Stroke

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Keywords

  • Registry
  • Thrombectomy Complications
  • Endovascular Hemostatic Therapy
03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 300 across 777 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with and without vessel perforation perforation during thrombectomy.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
1,000 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 90 days

07

Study locations

1 of 1 sites recruiting
  • University Hospital Basel
    Basel, 4031, Switzerland
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06394180
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
May 1, 2024
Start date
Dec 2, 2024
Primary completion
Dec 2026 (estimated)
Completion
Sep 2027 (estimated)
Last update
Mar 9, 2026

Study contacts

Victor Schulze-Zachau, MD
Contact
Victor.schulze-zachau@usb.ch
+41 61 328 56 32
Marios N Psychogios, Prof. Dr.
Contact
Marios.psychogios@usb.ch
+41 61 328 59 36
Victor Schulze-Zachau, MD
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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