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The purpose of this study is to evaluate the safety and effectiveness of Onyxâ„¢ LES in the treatment of subjects with active arterial bleeding in the peripheral vasculature outside of the heart and brain.
This is a pivotal, prospective, multi-center, non-randomized, single arm study. This study will enroll patients with active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by investigator. In this study, peripheral vasculature is defined as outside of the brain and heart.
Up to 135 subjects will be consented to achieve 119 enrolled at up to 25 sites in the US.
This study will have two visits post-index procedure including hospital discharge visit and 30-day follow-up visit. Reintervention visits will be captured through 30 days post-index procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Onyx LES | Experimental | Device; embolization with liquid embolic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Onyxâ„¢ Liquid Embolic System | Device | The proposed indication for Onyxâ„¢ LES is: Onyxâ„¢ LES is indicated for the embolization of arterial hemorrhage in the peripheral vasculature. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from Arterial Hemorrhage | Freedom from arterial hemorrhage in all target location(s) after treatment with Onyxâ„¢ LES at the index procedure without re-embolization or any other intervention at the target location(s) due to persistent or recurrent hemorrhage through 30 days. Freedom from arterial hemorrhage where an arterial hemorrhage event is defined as a type 3 or greater BARC bleeding criteria as assessed by the Clinical Events Committee (CEC) through 30 days. | Through 30 days post-index procedure |
| Freedom from System-related Major Adverse Events (MAE) | The primary safety endpoint is defined as freedom from system-related Major Adverse Events (MAE) through 30 days after the point of enrollment as assessed by the CEC. | Through 30 days post-index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Success | successful delivery and deployment of Onyxâ„¢ to the target location without non-target embolization or Onyxâ„¢ cast migration and the successful removal of the delivery system at the completion of the index procedure. | At the completion of the index procedure |
| Technical Success |
| Measure | Description | Time Frame |
|---|---|---|
| Ancillary Endpoint | Duration of the index procedure | Through index procedure |
| Ancillary Endpoint | Length of hospitalization, post-index procedure |
Inclusion Criteria:
Patient is ≥ 22 years old.
Active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by the investigator.
In this study, peripheral vasculature is defined as outside the brain and heart.
Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study.
Life expectancy of >30 days, in the opinion of the investigator at the time of enrollment.
Target treatment area is free from prior embolization treatment.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janki Shah | Contact | 7322662503 | janki.shah@medtronic.com | |
| Liza Marie | Contact | 7072172314 | liza.marie@medtronic.com |
| Name | Affiliation | Role |
|---|---|---|
| Osman Ahmed, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Phoenix | Arizona | 85054 | United States |
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|
Technical Success is defined as absence of angiographic signs of bleeding after Onyx â„¢ embolization at each target location based on core lab assessment. |
| At the completion of the index procedure |
| Reintervention | Reintervention is defined as the number of additional procedures needed to treat the target location(s) embolized with Onyxâ„¢ through 30 days following the index procedure. | Through 30 days post-index procedure |
| Transfusions | Transfusions defined as the number of blood transfusions required post-index procedure through 30 days will use blood transfusions starting after the removal of the delivery system. The number of blood units used for each transfusion will also be collected. | Through 30 days post-index procedure |
| Through 30 days post-index procedure |
| Ancillary Endpoint | Tabulate adjunctive use of other types of embolic agents to treat target locations at index procedure and reinterventions | Through 30 days post-index procedure |
| University of California, Irvine | Recruiting | Irvine | California | 92627 | United States |
|
| Stanford Medical Center | Recruiting | Palo Alto | California | 94304 | United States |
|
| UCHealth University of Colorado Hospital | Recruiting | Aurora | Colorado | 80045 | United States |
|
| Yale New Haven | Recruiting | New Haven | Connecticut | 06510 | United States |
|
| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
|
| University of Iowa Hospitals and Clinics | Recruiting | Iowa City | Iowa | 52242 | United States |
|
| Masschusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| CHI Health Creighton University Medical Center-Bergan-Mercy | Recruiting | Omaha | Nebraska | 68124 | United States |
|
| Rutgers New Jersey Medical School | Recruiting | Newark | New Jersey | 07103 | United States |
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| Albany Medical Center | Recruiting | Albany | New York | 12208 | United States |
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| The Mount Sinai | Recruiting | New York | New York | 10029 | United States |
|
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
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| The Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
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| University of Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15237 | United States |
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| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37212 | United States |
|
| Univ Of Texas Southwestern | Recruiting | Dallas | Texas | 75235 | United States |
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| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
|
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D006471 | Gastrointestinal Hemorrhage |
| D014456 | Ulcer |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004621 | Embolization, Therapeutic |
| ID | Term |
|---|---|
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
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