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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.
This feasibility study is a prospective, multi-center, single-arm study of the CATERPILLAR™ Arterial Embolization Device. Up to twenty (20) subjects will be treated with the CATERPILLAR™ Arterial Embolization Device at up to 5 investigational sites in New Zealand and Australia.
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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 | 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. | Index Procedure. |
| Freedom from Device-Related SAEs | Freedom from Device-Related Serious Adverse Events (SAE) through 30 day follow-up. | 30 (-7/+21) Days |
| 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. | Index Procedure |
| Freedom from Recanalization | Freedom from clinically relevant recanalization of the target embolization site(s) through 30 day follow-up as confirmed by the Investigator. Clinically relevant recanalization is defined as recanalization through the study device that requires a re-intervention. Freedom from recanalization will be reported for each target embolization site. |
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Clinical Inclusion Criteria:
Subject must voluntarily sign and date the approved Informed Consent Form (ICF) prior to collection of study data or performance of study 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: More than one target embolization site may be treated 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.
Clinical Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Holden, FRANZCR | Auckland City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydney Local Health District | Camperdown | New South Wales | Australia | |||
| Alfred Health |
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| 30 (-7/+21) Days |
| Freedom from Migration | Freedom from Migration will be reported for each study device as follows:
| 30 (-7/+21) Days |
| Freedom from Device and/or Procedure-Related Adverse Events | Freedom from device and/or procedure-related adverse events (AE) through 30 day follow-up. | 30 (-7/+21) Days |
| Investigator Satisfaction | The following will be reported by Investigators for each study device during the Index Procedure:
| Index Procedure |
| Melbourne |
| Victoria |
| Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| Auckland Hospital | Auckland | New Zealand |
| Clinical Trials New Zealand | Hamilton | New Zealand |