Arteriovenous Malformations, Benign Prostatic Hyperplasia, Hypervascular Tumors, Uterine Fibroid
Conditions
Brief summary
This registry study is designed to collect data on the procedural success and complication rates in real-world patients undergoing HydroPearl embolization procedures via radial access.
Interventions
DEVICETreatment with HydroPearl via radial access
This is an observational study collecting data on patients who are already being treated with HydroPearl on-label per standard of care.
Sponsors
Terumo Medical Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥ 18 years old 2. Subject is scheduled for a procedure for treatment with HydroPearl microspheres using radial access. 3. Subject is willing and able to complete follow-up requirements 4. Subject is willing and able to sign a written Informed Consent form prior to participating in the registry.
Exclusion criteria
1. Unable to have a procedure with radial access for any reason. 2. Participating in another clinical study which, in the opinion of the investigator, could impact the results of this registry. 3. Pregnant or planning to become pregnant during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success | Duration of procedure (measured from the time the participant is sedated (start of study procedure) until all products are removed from the participant and closure is confirmed (end of the intended study procedure)) | Defined as completing the planned procedure without femoral access bailout |
| Technical Success | Duration of procedure (from when the injection of HydroPearls is started until access site closure has been completed) | Delivery of HydroPearls to the target vessel and slowing the blood flow with microsphere embolization |
| Freedom From Major Adverse Events and Radial Access Complications | within 30 days post-procedure | Major Adverse Events are defined as the following: Death MI Stroke |
| Radial Access Related Complications Within 30 Days | 30 days post procedure | Radial access related complications that occurred within 30 days of the index procedure include, but are not limited to, the following: Radial Artery Occlusion (RAO) Hand Ischemia Arteriovenous Fistula Pseudoaneurysm Any complication requiring surgical and/or endovascular intervention within 30 days of the index procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Uterine Fibroid Embolization With HydroPearls Via Radial Access Patients will be separated into the following groups based on indication:
Uterine Fibroid Embolization (UFE)
All subjects will receive treatment with HydroPearl via radial access. | 70 |
| Prostatic Artery Embolization With HydroPearls Via Radial Access Patients will be separated into the following groups based on indication:
Prostatic Artery Embolization (PAE) to treat benign prostatic hyperplasia (BPH).
All subjects will receive treatment with HydroPearls via radial access. | 16 |
| Liver Tumor Embolization With HydroPearls Via Radial Access Patients will be separated into the following groups based on indication:
Liver Tumor Embolization (LT) to hypervascular tumors in the liver.
All subjects will receive treatment with HydroPearls via radial access. | 7 |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access Patients will be separated into the following groups based on indication:
Other Hypervascular Tumors (OHT) to treat hypervascular tumors located outside of the liver.
All subjects will receive treatment with HydroPearls via radial access. | 6 |
| Total | 99 |
Baseline characteristics
| Characteristic | Prostatic Artery Embolization With HydroPearls Via Radial Access | Liver Tumor Embolization With HydroPearls Via Radial Access | Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Uterine Fibroid Embolization With HydroPearls Via Radial Access | Total |
|---|---|---|---|---|---|
| Age, Continuous | 67.6 years | 59.6 years | 60.3 years | 44.3 years | 50.1 years |
| Medical History Atrial Fibrillation | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Medical History Hypercholesterolemia | 4 Participants | 1 Participants | 3 Participants | 3 Participants | 11 Participants |
| Medical History Hypertension | 7 Participants | 4 Participants | 6 Participants | 26 Participants | 43 Participants |
| Medical History Myocardial Infarction (MI) | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 1 Participants | 44 Participants | 49 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) White | 14 Participants | 4 Participants | 5 Participants | 19 Participants | 42 Participants |
| Region of Enrollment United States | 16 participants | 7 participants | 6 participants | 70 participants | 99 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 3 Participants | 70 Participants | 74 Participants |
| Sex: Female, Male Male | 16 Participants | 6 Participants | 3 Participants | 0 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 70 | 0 / 16 | 1 / 7 | 0 / 6 |
| other Total, other adverse events | 32 / 70 | 9 / 16 | 4 / 7 | 3 / 6 |
| serious Total, serious adverse events | 6 / 70 | 0 / 16 | 1 / 7 | 2 / 6 |
Outcome results
Primary
Freedom From Major Adverse Events and Radial Access Complications
Major Adverse Events are defined as the following: Death MI Stroke
Time frame: within 30 days post-procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Freedom From Major Adverse Events and Radial Access Complications | Freedom from Major Adverse Events and radial access complications within 30 days post procedure | 69 Participants |
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Freedom From Major Adverse Events and Radial Access Complications | Death within 30 days | 1 Participants |
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Freedom From Major Adverse Events and Radial Access Complications | Stroke within 30 days | 0 Participants |
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Freedom From Major Adverse Events and Radial Access Complications | MI within 30 days | 0 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Freedom From Major Adverse Events and Radial Access Complications | Death within 30 days | 0 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Freedom From Major Adverse Events and Radial Access Complications | Stroke within 30 days | 0 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Freedom From Major Adverse Events and Radial Access Complications | MI within 30 days | 0 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Freedom From Major Adverse Events and Radial Access Complications | Freedom from Major Adverse Events and radial access complications within 30 days post procedure | 16 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Freedom From Major Adverse Events and Radial Access Complications | Freedom from Major Adverse Events and radial access complications within 30 days post procedure | 6 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Freedom From Major Adverse Events and Radial Access Complications | Stroke within 30 days | 0 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Freedom From Major Adverse Events and Radial Access Complications | MI within 30 days | 0 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Freedom From Major Adverse Events and Radial Access Complications | Death within 30 days | 1 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Freedom From Major Adverse Events and Radial Access Complications | Stroke within 30 days | 0 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Freedom From Major Adverse Events and Radial Access Complications | Freedom from Major Adverse Events and radial access complications within 30 days post procedure | 6 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Freedom From Major Adverse Events and Radial Access Complications | Death within 30 days | 0 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Freedom From Major Adverse Events and Radial Access Complications | MI within 30 days | 0 Participants |
Primary
Procedural Success
Defined as completing the planned procedure without femoral access bailout
Time frame: Duration of procedure (measured from the time the participant is sedated (start of study procedure) until all products are removed from the participant and closure is confirmed (end of the intended study procedure))
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Procedural Success | 70 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Procedural Success | 16 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Procedural Success | 7 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Procedural Success | 6 Participants |
Primary
Radial Access Related Complications Within 30 Days
Radial access related complications that occurred within 30 days of the index procedure include, but are not limited to, the following: Radial Artery Occlusion (RAO) Hand Ischemia Arteriovenous Fistula Pseudoaneurysm Any complication requiring surgical and/or endovascular intervention within 30 days of the index procedure
Time frame: 30 days post procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Access site pain | 0 Participants |
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Vessel occlusion | 0 Participants |
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Hand Ischemia | 0 Participants |
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Arteriovenous fistula | 0 Participants |
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Pseudoaneurysm | 0 Participants |
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Vessel dissection | 0 Participants |
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Vessel spasm | 4 Participants |
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Artery perforation | 0 Participants |
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Distal embolization | 0 Participants |
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Hematoma at the puncture site | 4 Participants |
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Finger amputation/ loss of limb | 0 Participants |
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Other | 8 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Hand Ischemia | 0 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Vessel occlusion | 0 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Hematoma at the puncture site | 2 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Artery perforation | 0 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Finger amputation/ loss of limb | 0 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Other | 0 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Distal embolization | 0 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Vessel dissection | 0 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Pseudoaneurysm | 0 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Access site pain | 0 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Arteriovenous fistula | 0 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Vessel spasm | 0 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Arteriovenous fistula | 0 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Other | 0 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Pseudoaneurysm | 0 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Vessel dissection | 0 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Finger amputation/ loss of limb | 0 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Vessel spasm | 1 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Artery perforation | 0 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Distal embolization | 0 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Hematoma at the puncture site | 1 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Access site pain | 0 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Vessel occlusion | 0 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Hand Ischemia | 0 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Arteriovenous fistula | 0 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Hand Ischemia | 0 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Hematoma at the puncture site | 1 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Vessel spasm | 1 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Access site pain | 1 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Vessel occlusion | 0 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Vessel dissection | 0 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Other | 2 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Pseudoaneurysm | 0 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Distal embolization | 0 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Artery perforation | 0 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Radial Access Related Complications Within 30 Days | Finger amputation/ loss of limb | 0 Participants |
Primary
Technical Success
Delivery of HydroPearls to the target vessel and slowing the blood flow with microsphere embolization
Time frame: Duration of procedure (from when the injection of HydroPearls is started until access site closure has been completed)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Technical Success | Successful delivery of HydroPearls to target vessels | 69 Participants |
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Technical Success | Complete Embolization | 69 Participants |
| Uterine Fibroid Embolization With HydroPearls Via Radial Access | Technical Success | Partial Embolization | 1 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Technical Success | Complete Embolization | 14 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Technical Success | Partial Embolization | 2 Participants |
| Prostatic Artery Embolization With HydroPearls Via Radial Access | Technical Success | Successful delivery of HydroPearls to target vessels | 16 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Technical Success | Successful delivery of HydroPearls to target vessels | 7 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Technical Success | Partial Embolization | 0 Participants |
| Liver Tumor Embolization With HydroPearls Via Radial Access | Technical Success | Complete Embolization | 7 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Technical Success | Partial Embolization | 0 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Technical Success | Successful delivery of HydroPearls to target vessels | 6 Participants |
| Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access | Technical Success | Complete Embolization | 6 Participants |