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HISTOACRYL® Used for Embolization of Thoracoabdominal Artery Bleeding

Not Yet RecruitingN/A

Sponsor: Aesculap AG

Conditions: Hemorrhage, Gastrointestinal Hemorrhage, Hemoptysis, Postpartum Hemorrhage

Interventions: Embolization therapy

Countries: Japan

This observational study will collect information from adult patients in Japan who are treated with Histoacryl® to stop bleeding from arteries in the chest or abdomen, in order to better understand how well the treatment works and how safe it is during routine medical care.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Active thoracoabdominal arterial bleeding diagnosed by endoscopy, catheter angiography, or computed tomography angiography (CTA).
* Planned embolization treatment using Histoacryl® as the sole embolic agent for the target lesion.
* No endoleak following thoracic endovascular aortic repair (TEVAR) or endovascular abdominal aortic repair (EVAR).
* Patients with malignant tumors must have an expected survival of at least 1 month.
* Written informed consent obtained from the patient or a legally authorized representative.

Exclusion Criteria:

* Previous embolization in the target vascular territory.
* Known allergy or hypersensitivity to n-butyl cyanoacrylate (NBCA), Lipiodol®, or related treatment components.
* Use of adjunctive embolic agents in the same target location.
* Planned surgical treatment after embolization as part of a predefined two-step treatment strategy.
* Severe septicemia.
* Participation in another clinical trial.
* Target vessels unsuitable for safe Histoacryl® injection.
* Empiric embolization without identification of a target bleeding location.
* Pregnancy, with the exception of patients treated for postpartum hemorrhage.

Locations (11)

Nagoya, Aichi-ken, Japan
Toyoake, Aichi-ken, Japan
Kashiwa, Chiba, Japan
Gifu, Gifu, Japan
Sapporo, Hokkaido, Japan
Nishinomiya, Hyōgo, Japan
Kawasaki, Kawasaki, Japan
Kashihara, Nara, Japan
Nagaizumi-chō, Shizuoka, Japan
Tokyo, Tokyo, Japan
Tokyo, Tokyo, Japan