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

M
Matthew S. Johnson, MD

Primary Investigator

Enrolling By Invitation
18 years and older
All
Phase N/A
118 participants needed
2 Locations

Brief description of study

To evaluate the safety and effectiveness of Embrace Hydrogel Embolic System for theheter embolization of peripheral arterial bleeds.

Detailed description of study

A Prospective Multicenter Single-Arm Staged Study to Evaluate the Safety and Effectiveness ofbrace™ Hydrogel Embolic For Transcatheter Embolization of Arterial Bleeding in Solid Organsd Peripheral Arteries

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Arterial Bleeding in Solid Organs and Peripheral Arteries
  • Age: 18 Years
  • Gender: All

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

Updated on 01 Aug 2024. Study ID: INY-P-21-002
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