Arterial Bleeding in Solid Organs and Peripheral Arteries
Investigational drug(s) / intervention(s)
Embrace HES including Instylla™ Delivery Kit and Instylla™ Microcatheter
Embrace HES including Instylla™ Delivery Kit and Instylla™ Microcatheter: The Embrace Hydrogel Embolic System (HES) is indicated for embolization of peripheral arterial bleeds in vessels ≤6mm
Study summary
To evaluate the safety and effectiveness of Embrace Hydrogel Embolic System for the transcatheter embolization of peripheral arterial bleeds.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Male or female patients age ≥ 18 years old
2. 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:
1. Non-variceal Upper Gastrointestinal (UGI) bleeds refractory to endoscopic treatment
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 with risk 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 consent approved 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 to benefit from angioembolization (e.g., in the presence of significant polytrauma, multiple organ failure or shattered organs).
3. Any contraindication to arteriography or the embolization protocol utilized at treating institution.
4. 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).
5. Hemorrhagic shock (Class IV-see Appendix 1) at time of treatment
6. 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.
7. Embolization for treatment of spinal arteries, lower GI bleeds, arteriovenous malformations, embolization of arteriovenous shunts, endoleak management, neurovascular 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 discrete vascular territories/arterial injuries (requires that microcatheter be repositioned to discrete 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 safe and intended embolization.
11. Known allergies (based on history) to PEG, ferrous compounds, tert Butyl Hydroperoxide, contrast media or procedural sedatives/anesthetics that is not amenable to pre-medication
12. Presence of medically relevant localized or systemic infection
13. The patient has other concurrent conditions or known history that in the opinion of the Investigator would be unlikely to receive clinical benefit from the study procedure or participation in the study may compromise patient safety or study objectives (including but not limited to ongoing acute infection, life-threatening concomitant trauma or conditions).
14. Presence of Uncorrectable Coagulopathy: Defined as thrombocytopenia with platelet counts \< 40,000/mm3 and/or INR \> 2.0.
15. If known, enrollment in a concurrent study in which the study treatment may confound the evaluation of the study device.
Primary outcome measure(s)
Primary safety endpoint — Through 30 days post-index procedure Freedom from major adverse events (MAE)
Clinical Success — Within 30 days of the index procedure Defined as the absence of bleeding from the target lesion after embolization with Embrace HES without the need for subsequent embolic devices in the index procedure, emergency surgery, re-embolization or other target vessel re-interventions due to rebleeding.
Technical Success — Immediately following index procedure Defined as occlusion of the target vessel or exclusion of the area of arterial damage and/or the cessation of extravasation on angiography after embolization with Embrace HES.
Trial sites (22)
Facility
City
Region
Status
Banner Health
Phoenix
Arizona
Memorial Health Services
Long Beach
California
Stanford University
Stanford
California
UCLA Harbor Lindquist Institute
Torrance
California
Nuvance Health
Danbury
Connecticut
Yale University
New Haven
Connecticut
Medstar Georgetown University
Washington D.C.
District of Columbia
University of Miami
Miami
Florida
Northwestern
Evanston
Illinois
Indiana University
Indianapolis
Indiana
University of Maryland
Baltimore
Maryland
Massachusetts General Hospital
Boston
Massachusetts
Boston Medical Center
Boston
Massachusetts
Mount Sinai Hospital
New York
New York
Columbia University Milstein
New York
New York
UNC School of Medicine
Chapel Hill
North Carolina
University of Cincinnati
Cincinnati
Ohio
University of Oklahoma
Oklahoma City
Oklahoma
University of Pennsylvania
Philadelphia
Pennsylvania
University of Pittsburgh
Pittsburgh
Pennsylvania
Prisma Health
Greenville
South Carolina
Medical College of Wisconsin
Milwaukee
Wisconsin
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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