(HALT) Embrace Hydrogel Embolic System (HES) Study of Embolization in Peripheral Arterial Bleeds

Not Applicable

Recruiting

• Conditions: Arterial Bleeding in Solid Organs and Peripheral Arteries

• Registration Number: NCT05364502
• Lead Sponsor: Instylla, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-5-3
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Male or female patients age = 18 years old<br><br> 2. Subjects who are candidates for transarterial catheter embolization with arterial<br> bleeding documented on a suitable radiologic imaging and/or endoscopic visualization<br> study taken during the index hospitalization that allows for the source of the<br> arterial injury/bleeding to be localized. Includes (but not limited to) the<br> following:<br><br> 1. Non-variceal Upper Gastrointestinal (UGI) bleeds refractory to endoscopic<br> treatment<br><br> 2. End organ/visceral bleeds (kidney, liver and spleen including tumor bleeds)<br><br> 3. Spontaneous hematoma (e.g., rectus sheath and psoas muscle hematomas)<br><br> 4. Other peripheral arterial bleeds (e.g., pelvic hemorrhage) if not associated<br> with risk of ischemia distal to the lesion or embolization of non-expendable<br> arteries.<br><br> 3. Subjects with at least one target vessel =6mm and Embrace HES can be delivered to<br> the target vessel(s).<br><br> 4. Subject is willing to comply with follow-up evaluation schedule.<br><br> 5. No prior embolization in the target territory prior to study entry<br><br> 6. The subject or a legally authorized representative has provided informed consent<br> approved by the appropriate local IRB/EC.<br><br>Exclusion Criteria:<br><br> 1. Life expectancy = 30 days<br><br> 2. In the Investigator's opinion, due to injury severity the subject is not likely to<br> benefit from angioembolization (e.g., in the presence of significant polytrauma,<br> multiple organ failure or shattered organs).<br><br> 3. Any contraindication to arteriography or the embolization protocol utilized at<br> treating institution.<br><br> 4. Pregnant or breast-feeding (women of child-bearing potential must undergo a<br> pregnancy test performed in accordance with local institutional requirements and<br> agree to use contraception for at least six months).<br><br> 5. Hemorrhagic shock (Class IV-see Appendix 1) at time of treatment<br><br> 6. Target vascular territory supplied by the pulmonary artery, coronary artery, or<br> cerebral or cerebellar artery (requiring embolization of these arteries) or the<br> artery to be embolized has connections to these arteries via a collateral pathway.<br><br> 7. Embolization for treatment of spinal arteries, lower GI bleeds, arteriovenous<br> malformations, embolization of arteriovenous shunts, endoleak management,<br> neurovascular bleeds, penetrating trauma of extremities.<br><br> 8. Forrest Classification Type III UGI bleeds (see Appendix 2)<br><br> 9. In the investigator's opinion, patient will require embolization of 4 or more<br> discrete vascular territories/arterial injuries (requires that microcatheter be<br> repositioned to discrete area) based on diagnostic angiography or another suitable<br> imaging study.<br><br> 10. Known or suspected angio-anatomical conditions that in the Investigator's opinion,<br> would prevent the delivery catheter to gain access to the selected position for safe<br> and intended embolization.<br><br> 11. Known allergies (based on history) to PEG, ferrous compounds, tert Butyl<br> Hydroperoxide, contrast media or procedural sedatives/anesthetics that is not<br> amenable to pre-medication<br><br> 12. Presence of medically relevant localized or systemic infection<br><br> 13. The patient has other concurrent conditions or known history that in the opinion of<br> the Investigator would be unlikely to receive clinical benefit from the study<br> procedure or participation in the study may compromise patient safety or study<br> objectives (including but not limited to ongoing acute infection, life-threatening<br> concomitant trauma or conditions).<br><br> 14. If known, enrollment in a concurrent study in which the study treatment may confound<br> the evaluation of the study device.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary safety endpoint;Clinical Success;Technical Success