HISTOACRYL® Used for Embolization of Thoracoabdominal Artery Bleeding
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAesculap AG
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adults with active thoracoabdominal arterial bleeding requiring endovascular embolization will be enrolled at approximately 11 centers in Japan. Eligible patients must be scheduled to undergo embolization with Histoacryl® according to routine clinical practice and within the approved indication in Japan. The study population is expected to include patients with bleeding of various etiologies, including traumatic, iatrogenic, gastrointestinal, pulmonary (hemoptysis), obstetric, neoplastic, or other thoracoabdominal arterial hemorrhages.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Embolization therapy
DeviceEmbolization of Thoracoabdominal Artery Bleeding (TAB), excluding "Cardiac blood vessels other than Pulmonary artery", "Endoscopic esophageal varices embolization operations", and "Pulmonary artery malformation".
Treatment groups
176 Participants
are divided into 1 treatment groupGroup A: Embolization1 intervention
Trial outcomes
Primary outcomes
1
Clinical Success at 1 Month After Histoacryl® Embolization
Clinical success is defined as absence of bleeding from the target location after embolization with Histoacryl® without need for re-embolization or other re-interventions of the target lesion due to persistent or recurrent hemorrhage. Assessment performed on a per-patient basis.
Time frame
30 ± 10 days after index embolization procedureSecondary outcomes
1
Technical Success of Embolarization
Technical success is defined as absence of angiographic evidence of bleeding from the target location at completion of the index embolization procedure. Assessment performed on a per-lesion basis.
Time frame
Immediately after completion of the index procedure2
Clinical Success at 7 Days
Clinical success defined as absence of bleeding from the target location after embolization without need for re-embolization or other re-interventions due to persistent or recurrent hemorrhage.
Time frame
7 ± 2 days after embolarization3
Clinical Success at 3 Months (Optional Follow-up)
Clinical success as defined for the primary endpoint, assessed at optional long-term follow-up.
Time frame
90 ± 15 days after embolization4
Successful Device Delivery
Successful delivery is defined as administration of Histoacryl® with intact microcatheter retrieval at the end of the embolization procedure.
Time frame
During the index embolization procedureSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: