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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Placement of the CATERPILLAR™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
Sydney Local Health District
Camperdown, New South Wales, Australia
Alfred Health
Melbourne, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Auckland Hospital
Auckland, New Zealand
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.
Time frame: Index Procedure.
Freedom from Device-Related SAEs
Freedom from Device-Related Serious Adverse Events (SAE) through 30 day follow-up.
Time frame: 30 (-7/+21) Days
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: 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.
Time frame: 30 (-7/+21) Days
Freedom from Migration
Freedom from Migration will be reported for each study device as follows: * 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 clinically relevant migration of the study device(s) through 30 day follow-up as confirmed by the Investigator. Clinically relevant migration is defined as migration of the study device from the target embolization site that requires a re-intervention.
Time frame: 30 (-7/+21) Days
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Clinical Trials New Zealand
Hamilton, New Zealand
Freedom from Device and/or Procedure-Related Adverse Events
Freedom from device and/or procedure-related adverse events (AE) through 30 day follow-up.
Time frame: 30 (-7/+21) Days
Investigator Satisfaction
The following will be reported by Investigators for each study device during the Index Procedure: * Accurate delivery of the CATERPILLAR™ Arterial Embolization Device to the target embolization site * Ease of CATERPILLAR™ Arterial Embolization Device trackability and deliverability * Acceptability of CATERPILLAR™ Arterial Embolization Device visibility under fluoroscopy
Time frame: Index Procedure