Active — Not RecruitingNot Applicable

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

United States130 participantsStarted 2022-12-12

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female patients age ≥ 18 years old
✓. Subjects who are candidates for transarterial catheter embolization with arterial bleeding documented on a suitable radiologic imaging and/or endoscopic visualization study taken during the index hospitalization that allows for the source of the arterial injury/bleeding to be localized. Includes (but not limited to) the following:
✓. Non-variceal Upper Gastrointestinal (UGI) bleeds refractory to endoscopic treatment
✓. End organ/visceral bleeds (kidney, liver and spleen including tumor bleeds)
✓. Spontaneous hematoma (e.g., rectus sheath and psoas muscle hematomas)
✓. Other peripheral arterial bleeds (e.g., pelvic hemorrhage) if not associated with risk of ischemia distal to the lesion or embolization of non-expendable arteries.
✓. Subjects with at least one target vessel ≤6mm and Embrace HES can be delivered to the target vessel(s).
✓. Subject is willing to comply with follow-up evaluation schedule.

✕. Life expectancy ≤ 30 days
✕. In the Investigator's opinion, due to injury severity the subject is not likely to benefit from angioembolization (e.g., in the presence of significant polytrauma, multiple organ failure or shattered organs).
✕. Any contraindication to arteriography or the embolization protocol utilized at treating institution.
✕. Pregnant or breast-feeding (women of child-bearing potential must undergo a pregnancy test performed in accordance with local institutional requirements and agree to use contraception for at least six months).
✕. Hemorrhagic shock (Class IV-see Appendix 1) at time of treatment
✕. Target vascular territory supplied by the pulmonary artery, coronary artery, or cerebral or cerebellar artery (requiring embolization of these arteries) or the artery to be embolized has connections to these arteries via a collateral pathway.
✕. Embolization for treatment of spinal arteries, lower GI bleeds, arteriovenous malformations, embolization of arteriovenous shunts, endoleak management, neurovascular bleeds, penetrating trauma of extremities.
✕. Forrest Classification Type III UGI bleeds (see Appendix 2)

Primary safety endpoint

Timeframe: Through 30 days post-index procedure

Clinical Success

Timeframe: Within 30 days of the index procedure

Technical Success

Timeframe: Immediately following index procedure

NCT IDNCT05364502

SponsorInstylla, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female patients age ≥ 18 years old
✓. Subjects who are candidates for transarterial catheter embolization with arterial bleeding documented on a suitable radiologic imaging and/or endoscopic visualization study taken during the index hospitalization that allows for the source of the arterial injury/bleeding to be localized. Includes (but not limited to) the following:
✓. Non-variceal Upper Gastrointestinal (UGI) bleeds refractory to endoscopic treatment
✓. End organ/visceral bleeds (kidney, liver and spleen including tumor bleeds)
✓. Spontaneous hematoma (e.g., rectus sheath and psoas muscle hematomas)
✓. Other peripheral arterial bleeds (e.g., pelvic hemorrhage) if not associated with risk of ischemia distal to the lesion or embolization of non-expendable arteries.
✓. Subjects with at least one target vessel ≤6mm and Embrace HES can be delivered to the target vessel(s).
✓. Subject is willing to comply with follow-up evaluation schedule.

✕. Life expectancy ≤ 30 days
✕. In the Investigator's opinion, due to injury severity the subject is not likely to benefit from angioembolization (e.g., in the presence of significant polytrauma, multiple organ failure or shattered organs).
✕. Any contraindication to arteriography or the embolization protocol utilized at treating institution.
✕. Pregnant or breast-feeding (women of child-bearing potential must undergo a pregnancy test performed in accordance with local institutional requirements and agree to use contraception for at least six months).
✕. Hemorrhagic shock (Class IV-see Appendix 1) at time of treatment
✕. Target vascular territory supplied by the pulmonary artery, coronary artery, or cerebral or cerebellar artery (requiring embolization of these arteries) or the artery to be embolized has connections to these arteries via a collateral pathway.
✕. Embolization for treatment of spinal arteries, lower GI bleeds, arteriovenous malformations, embolization of arteriovenous shunts, endoleak management, neurovascular bleeds, penetrating trauma of extremities.
✕. Forrest Classification Type III UGI bleeds (see Appendix 2)