- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04090320
CATERPILLAR™ Arterial Embolization Device Study (CHRYSALIS)
A Prospective, Multi-Center, Single-Arm Study Assessing the Clinical Use of the CATERPILLAR™ Arterial Embolization Device System for Arterial Embolization in the Peripheral Vasculature (CHRYSALIS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New South Wales
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Camperdown, New South Wales, Australia
- Sydney Local Health District
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Victoria
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Melbourne, Victoria, Australia
- Alfred Health
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Western Australia
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Perth, Western Australia, Australia, 6000
- Royal Perth Hospital
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Auckland, New Zealand
- Auckland Hospital
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Hamilton, New Zealand
- Clinical Trials New Zealand
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- The subject's access vessel(s) preclude safe insertion of the delivery catheter.
- The subject's target embolization site(s) is located within a vein.
- The subject's target embolization site(s) is located within the head, neck, heart or coronary vessels.
- 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).
- 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.
- The subject has a known allergy or hypersensitivity to contrast media that cannot be adequately pre-medicated.
- The subject has a known allergy or hypersensitivity to any of the device materials including: cobalt, chromium, nickel, titanium, platinum, iridium, polyurethane or polyethylene.
- The subject will receive anticoagulant or antiplatelet therapy (e.g. direct thrombin inhibitors, factor Xa inhibitors, vitamin K antagonists) before, during and/or after treatment with the study device, which, in the opinion of the Investigator, would clinically interfere with the study endpoints.
- The subject has a known uncontrolled blood coagulation or bleeding disorder.
- The subject has an unresolved systemic infection.
- 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.
- 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.
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CATERPILLAR™ Arterial Embolization Device
Placement of the CATERPILLAR™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).
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Placement of the CATERPILLAR™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technical Success
Time Frame: Index Procedure.
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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.
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Index Procedure.
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Freedom from Device-Related SAEs
Time Frame: 30 (-7/+21) Days
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Freedom from Device-Related Serious Adverse Events (SAE) through 30 day follow-up.
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30 (-7/+21) Days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time Point of Occlusion
Time Frame: Index Procedure
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The percentage of target embolization site(s) with occlusion at ≤1, ≤2, ≤3, ≤4, ≤5, ≤10 and >10 minutes post-treatment.
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Index Procedure
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Freedom from Recanalization
Time Frame: 30 (-7/+21) Days
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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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30 (-7/+21) Days
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Freedom from Migration
Time Frame: 30 (-7/+21) Days
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Freedom from Migration will be reported for each study device as follows:
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30 (-7/+21) Days
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Freedom from Device and/or Procedure-Related Adverse Events
Time Frame: 30 (-7/+21) Days
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Freedom from device and/or procedure-related adverse events (AE) through 30 day follow-up.
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30 (-7/+21) Days
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Investigator Satisfaction
Time Frame: Index Procedure
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The following will be reported by Investigators for each study device during the Index Procedure:
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Index Procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrew Holden, FRANZCR, Auckland City Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BPV-16-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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