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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caterpillar™ Arterial Embolization Device | Experimental | Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caterpillar™ Arterial Embolization Device | Device | Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the Index Procedure |
| Freedom From Device-Related SAEs | Freedom from device-related serious adverse events (SAE) through 30-day follow-up. | 30 (-7/+21) Days post Index Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During Index Procedure |
| Freedom From Recanalization |
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Inclusion Criteria:
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.
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.
Subject must be willing and able to comply with protocol requirements, including all study visits and procedures.
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
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).
The target embolization site(s) must have a landing zone sufficient to accommodate the device implant lengths shown in the IFU.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Rilling, MD, FSIR | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dignity Health/St. Joseph's & Medical Center | Phoenix | Arizona | 85013 | United States | ||
| Baptist Hospital of Miami |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Units | Target Embolization Sites | During the Index Procedure | Target Embolization Sites | Target Embolization Sites |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Obstruction Gastric | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Vander Ploeg | BD | 602-751-3268 | heather.vander.ploeg@bd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2020 | Sep 13, 2022 | Prot_SAP_000.pdf |
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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.
| 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure |
| 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. | During Index Procedure |
| 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. | 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 | Freedom from device and/or procedure-related adverse events (AE) through 30-days, 6 and 12-months follow-up. | 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure |
| Accuracy of Delivery | Accurate delivery of the study device to the target embolization site as assessed by the Investigator. | During Index Procedure |
| Ease of Trackability/Deliverability | Ease of study device trackability and deliverability as assessed by the Investigator. | During Index Procedure |
| Ease of Detachment | Ease of study device detachment as assessed by the Investigator. | During Index Procedure |
| Acceptability of Visibility Under Fluoroscopy | Acceptability of study device visibility under fluoroscopy as assessed by the Investigator. | During Index Procedure |
| Miami |
| Florida |
| 33176 |
| United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| University of Kansas Medical Center Research Institute | Kansas City | Kansas | 66160 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Minnesota Medical Center - Fairview | Minneapolis | Minnesota | 55455 | United States |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Cardiothoracic and Vascular Surgeons | Austin | Texas | 78756 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| The Medical College of Wisconsin, Inc. | Milwaukee | Wisconsin | 53226 | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Target Embolization Sites |
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| Primary | Freedom From Device-Related SAEs | Freedom from device-related serious adverse events (SAE) through 30-day follow-up. | Posted | Count of Participants | Participants | 30 (-7/+21) Days post Index Procedure |
|
|
|
| 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. | Posted | Count of Units | Target Embolization Sites (TESs) | During Index Procedure | Target Embolization Sites (TESs) | Target Embolization Sites (TESs) |
|
|
|
| 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. | Number of TESs analyzed at 6-Months and 12-Months differs from 30-Day follow-up due to subject discontinuation in the study | Posted | Count of Units | Target Embolization Sites (TESs) | 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure | Target Embolization Sites (TESs) | 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. | Posted | Count of Units | Target Embolization Sites (TESs) | During Index Procedure | Target Embolization Sites (TESs) | Target Embolization Sites (TESs) |
|
|
|
| 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. | Number of devices analyzed at 6-Months and 12-Months differs from 30-Day follow-up due to subject discontinuation in the study | Posted | Count of Units | Devices | 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure | Devices | Devices |
|
|
|
| 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. | Number of Participants analyzed at 6-Months and 12-Months differs from 30-Day follow-up due to subject discontinuation | Posted | Count of Participants | Participants | 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure |
|
|
|
| Secondary | Accuracy of Delivery | Accurate delivery of the study device to the target embolization site as assessed by the Investigator. | Posted | Count of Units | Target Embolization Sites (TESs) | During Index Procedure | Target Embolization Sites (TESs) | Target Embolization Sites (TESs) |
|
|
|
| Secondary | Ease of Trackability/Deliverability | Ease of study device trackability and deliverability as assessed by the Investigator. | Posted | Count of Units | Target Embolization Sites (TESs) | During Index Procedure | Target Embolization Sites (TESs) | Target Embolization Sites (TESs) |
|
|
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| Secondary | Ease of Detachment | Ease of study device detachment as assessed by the Investigator. | Posted | Count of Units | Target Embolization Sites (TESs) | During Index Procedure | Target Embolization Sites (TESs) | Target Embolization Sites (TESs) |
|
|
|
| Secondary | Acceptability of Visibility Under Fluoroscopy | Acceptability of study device visibility under fluoroscopy as assessed by the Investigator. | Posted | Count of Units | Target Embolization Sites (TESs) | During Index Procedure | Target Embolization Sites (TESs) | Target Embolization Sites (TESs) |
|
|
|
| 5 |
| 50 |
| 11 |
| 50 |
| 6 |
| 50 |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Hepatic Cirrhosis | Hepatobiliary disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 23.1 | Non-systematic Assessment |
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| Breast Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
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| Colorectal Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
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| Hepatocellular Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Non-systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
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Investigator seeking publication shall submit to Sponsor for review a draft of the proposed publication at least 60 days prior to submission of the draft for publication. Sponsor shall have the right to: (i) review and make editorial comments on any such proposed publication; and (ii) make any results from the Study known to its customers and governmental agencies prior to publication.
| Title | Measurements |
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| ≤ 4 minutes |
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| ≤ 5 minutes |
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| ≤ 10 minutes |
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| > 10 minutes |
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| 6-Month Follow-up |
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| 12-Month Follow-up |
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| 6-Month Follow-up |
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| 12-Month Follow-up |
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| 12-Month Follow-up |
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