Embolization, Therapeutic
Conditions
Keywords
Arterial Embolization, Vascular Plug
Brief summary
The primary objective of this study is to evaluate the performance and safety of the Caterpillar™ Arterial Embolization Device when used for arterial embolization in the peripheral vasculature in a real world, on-label application.
Detailed description
The post-market study is a prospective, multi-center, single-arm, real world study of the Caterpillar™ Arterial Embolization Device. Enrollment will continue until up to fifty (50) subjects have been treated with the Caterpillar™ Arterial Embolization Device at up to 20 investigational sites in the United States.
Interventions
Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject or Legally Authorized Representative (LAR) must voluntarily sign and date the approved Informed Consent Form (ICF) prior to collection of study-specific data or performance of study-specific procedures. 2. Subject must be either male or non-pregnant female ≥18 years of age with an expected lifespan sufficient to allow for completion of all study procedures. 3. Subject must be willing and able to comply with protocol requirements, including all study visits and procedures. 4. Subject must require peripheral vascular occlusion at an arterial target embolization site(s) that can be treated with the Caterpillar™ Arterial Embolization Device according to the Instructions for Use (IFU). Note: Per Investigator discretion, up to five (5) Target Embolization Sites may be treated with up to ten (10) study devices per subject. Angiographic Inclusion Criteria 5. The target embolization site(s) must be located in a native arterial vessel(s) with the intended arterial vessel diameter ranges shown in the IFU, as assessed by the Investigator (via visual estimate). 6. The target embolization site(s) must have a landing zone sufficient to accommodate the device implant lengths shown in the IFU.
Exclusion criteria
1. The subject's access vessel(s) preclude safe insertion of the delivery catheter. 2. The subject's target embolization site(s) is located within a vein. 3. The subject's target embolization site(s) is located within the head, neck, heart or coronary vessels. 4. The subject's target embolization site(s) is located across highly locomotive joints or muscle beds (e.g. elbow, hip, knee, shoulder, thoracic inlet/outlet). 5. The subject's target embolization site(s) is located in a high-flow vessel where, in the opinion of the Investigator, there may be significant risk of migration and unintended (non-target site) occlusion. 6. The subject has a known allergy or hypersensitivity to contrast media that cannot be adequately pre-medicated. 7. The subject has a known allergy or hypersensitivity to any of the device materials including: cobalt, chromium, nickel, titanium, platinum, iridium, polyurethane or polyethylene. 8. The subject has planned use of anticoagulant (e.g. direct thrombin inhibitors, factor Xa inhibitors, vitamin K antagonists) or antiplatelet therapy before, during and/or after treatment with the study device, which, in the opinion of the Investigator, would clinically interfere with the study endpoints. 9. The subject has a known uncontrolled blood coagulation or bleeding disorder. 10. The subject has an unresolved systemic infection. 11. The subject's required pre-operative laboratory tests and/or physical examination indicate abnormal results, which, in the opinion of the Investigator, would clinically interfere with the study endpoints. 12. The subject has a connective tissue disorders (e.g. Ehlers-Danlos Syndrome), arteritis (e.g. Takayasu's Disease) or another circulatory disorder, which, in the opinion of the Investigator, would clinically interfere with the study endpoints. 13. The subject has another medical condition which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, may confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up. 14. The subject is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | During the Index Procedure | Successful occlusion of the target embolization site(s) as confirmed by the Investigator via angiographic assessment during the Index Procedure. Technical success will be reported for each target embolization site. |
| Freedom From Device-Related SAEs | 30 (-7/+21) Days post Index Procedure | Freedom from device-related serious adverse events (SAE) through 30-day follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Acute Migration | During Index Procedure | Freedom from clinically relevant acute migration of the study device(s) as confirmed by the Investigator via angiographic assessment during the Index Procedure. Clinically relevant migration is defined as migration of the study device from the target embolization site that requires intervention. |
| Freedom From Non-Acute Migration | 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure | Freedom from clinically relevant migration of the study device(s) through 30 day, 6 month and 12 month follow-up was reported by the Investigators. Clinically relevant migration is defined as migration of the study device from the target embolization site that requires intervention. |
| Freedom From Device and/or Procedure-Related Adverse Events | 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure | Freedom from device and/or procedure-related adverse events (AE) through 30-days, 6 and 12-months follow-up. |
| Time Point of Occlusion | During Index Procedure | The percentage of target embolization site(s) with occlusion at ≤1, ≤2, ≤3, ≤4, ≤5, ≤10 and \>10 minutes post-treatment. |
| Ease of Trackability/Deliverability | During Index Procedure | Ease of study device trackability and deliverability as assessed by the Investigator. |
| Ease of Detachment | During Index Procedure | Ease of study device detachment as assessed by the Investigator. |
| Acceptability of Visibility Under Fluoroscopy | During Index Procedure | Acceptability of study device visibility under fluoroscopy as assessed by the Investigator. |
| Accuracy of Delivery | During Index Procedure | Accurate delivery of the study device to the target embolization site as assessed by the Investigator. |
| Freedom From Recanalization | 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure | Freedom from clinically relevant recanalization of the target embolization site(s) through 30-days, 6 and 12-months follow-up as confirmed by the Investigator. Clinically relevant recanalization is defined as recanalization through the study device that requires a re-intervention. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Caterpillar™ Arterial Embolization Device Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).
Caterpillar™ Arterial Embolization Device: Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Caterpillar™ Arterial Embolization Device |
|---|---|
| Age, Continuous | 58.9 years STANDARD_DEVIATION 14.51 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment United States | 50 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 50 |
| other Total, other adverse events | 6 / 50 |
| serious Total, serious adverse events | 11 / 50 |
Outcome results
Primary
Freedom From Device-Related SAEs
Freedom from device-related serious adverse events (SAE) through 30-day follow-up.
Time frame: 30 (-7/+21) Days post Index Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Caterpillar™ Arterial Embolization Device | Freedom From Device-Related SAEs | 50 Participants |
Primary
Technical Success
Successful occlusion of the target embolization site(s) as confirmed by the Investigator via angiographic assessment during the Index Procedure. Technical success will be reported for each target embolization site.
Time frame: During the Index Procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Caterpillar™ Arterial Embolization Device | Technical Success | 55 Target Embolization Sites |
Secondary
Acceptability of Visibility Under Fluoroscopy
Acceptability of study device visibility under fluoroscopy as assessed by the Investigator.
Time frame: During Index Procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Caterpillar™ Arterial Embolization Device | Acceptability of Visibility Under Fluoroscopy | 59 Target Embolization Sites (TESs) |
Secondary
Accuracy of Delivery
Accurate delivery of the study device to the target embolization site as assessed by the Investigator.
Time frame: During Index Procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Caterpillar™ Arterial Embolization Device | Accuracy of Delivery | 61 Target Embolization Sites (TESs) |
Secondary
Ease of Detachment
Ease of study device detachment as assessed by the Investigator.
Time frame: During Index Procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Caterpillar™ Arterial Embolization Device | Ease of Detachment | 62 Target Embolization Sites (TESs) |
Secondary
Ease of Trackability/Deliverability
Ease of study device trackability and deliverability as assessed by the Investigator.
Time frame: During Index Procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Caterpillar™ Arterial Embolization Device | Ease of Trackability/Deliverability | 61 Target Embolization Sites (TESs) |
Secondary
Freedom From Acute Migration
Freedom from clinically relevant acute migration of the study device(s) as confirmed by the Investigator via angiographic assessment during the Index Procedure. Clinically relevant migration is defined as migration of the study device from the target embolization site that requires intervention.
Time frame: During Index Procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Caterpillar™ Arterial Embolization Device | Freedom From Acute Migration | 62 Target Embolization Sites (TESs) |
Secondary
Freedom From Device and/or Procedure-Related Adverse Events
Freedom from device and/or procedure-related adverse events (AE) through 30-days, 6 and 12-months follow-up.
Time frame: 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure
Population: Number of Participants analyzed at 6-Months and 12-Months differs from 30-Day follow-up due to subject discontinuation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Caterpillar™ Arterial Embolization Device | Freedom From Device and/or Procedure-Related Adverse Events | 30-Day Follow-up | 42 Participants |
| Caterpillar™ Arterial Embolization Device | Freedom From Device and/or Procedure-Related Adverse Events | 6-Month Follow-up | 31 Participants |
| Caterpillar™ Arterial Embolization Device | Freedom From Device and/or Procedure-Related Adverse Events | 12-Month Follow-up | 23 Participants |
Secondary
Freedom From Non-Acute Migration
Freedom from clinically relevant migration of the study device(s) through 30 day, 6 month and 12 month follow-up was reported by the Investigators. Clinically relevant migration is defined as migration of the study device from the target embolization site that requires intervention.
Time frame: 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure
Population: Number of devices analyzed at 6-Months and 12-Months differs from 30-Day follow-up due to subject discontinuation in the study
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Caterpillar™ Arterial Embolization Device | Freedom From Non-Acute Migration | 30-Day Follow-up | 62 Devices |
| Caterpillar™ Arterial Embolization Device | Freedom From Non-Acute Migration | 6-Month Follow-up | 47 Devices |
| Caterpillar™ Arterial Embolization Device | Freedom From Non-Acute Migration | 12-Month Follow-up | 34 Devices |
Secondary
Freedom From Recanalization
Freedom from clinically relevant recanalization of the target embolization site(s) through 30-days, 6 and 12-months follow-up as confirmed by the Investigator. Clinically relevant recanalization is defined as recanalization through the study device that requires a re-intervention.
Time frame: 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure
Population: Number of TESs analyzed at 6-Months and 12-Months differs from 30-Day follow-up due to subject discontinuation in the study
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Caterpillar™ Arterial Embolization Device | Freedom From Recanalization | 30-Day Follow-up | 56 Target Embolization Sites (TESs) |
| Caterpillar™ Arterial Embolization Device | Freedom From Recanalization | 6-Month Follow-up | 43 Target Embolization Sites (TESs) |
| Caterpillar™ Arterial Embolization Device | Freedom From Recanalization | 12-Month Follow-up | 31 Target Embolization Sites (TESs) |
Secondary
Time Point of Occlusion
The percentage of target embolization site(s) with occlusion at ≤1, ≤2, ≤3, ≤4, ≤5, ≤10 and \>10 minutes post-treatment.
Time frame: During Index Procedure
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Caterpillar™ Arterial Embolization Device | Time Point of Occlusion | ≤1 minute | 15 Target Embolization Sites (TESs) |
| Caterpillar™ Arterial Embolization Device | Time Point of Occlusion | ≤ 2 minutes | 10 Target Embolization Sites (TESs) |
| Caterpillar™ Arterial Embolization Device | Time Point of Occlusion | ≤ 3 minutes | 7 Target Embolization Sites (TESs) |
| Caterpillar™ Arterial Embolization Device | Time Point of Occlusion | ≤ 4 minutes | 1 Target Embolization Sites (TESs) |
| Caterpillar™ Arterial Embolization Device | Time Point of Occlusion | ≤ 5 minutes | 11 Target Embolization Sites (TESs) |
| Caterpillar™ Arterial Embolization Device | Time Point of Occlusion | ≤ 10 minutes | 5 Target Embolization Sites (TESs) |
| Caterpillar™ Arterial Embolization Device | Time Point of Occlusion | > 10 minutes | 6 Target Embolization Sites (TESs) |