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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04090320




Registration number
NCT04090320
Ethics application status
Date submitted
12/09/2019
Date registered
16/09/2019
Date last updated
2/09/2020

Titles & IDs
Public title
CATERPILLAR™ Arterial Embolization Device Study
Scientific title
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)
Secondary ID [1] 0 0
BPV-16-002
Universal Trial Number (UTN)
Trial acronym
CHRYSALIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Embolization, Therapeutic 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - CATERPILLAR™ Arterial Embolization Device

Experimental: CATERPILLAR™ Arterial Embolization Device - Placement of the CATERPILLAR™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).


Treatment: Devices: CATERPILLAR™ Arterial Embolization Device
Placement of the CATERPILLAR™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Index Procedure.
Primary outcome [2] 0 0
Freedom from Device-Related SAEs - Freedom from Device-Related Serious Adverse Events (SAE) through 30 day follow-up.
Timepoint [2] 0 0
30 (-7/+21) Days
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Index Procedure
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
30 (-7/+21) Days
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
30 (-7/+21) Days
Secondary outcome [4] 0 0
Freedom from Device and/or Procedure-Related Adverse Events - Freedom from device and/or procedure-related adverse events (AE) through 30 day follow-up.
Timepoint [4] 0 0
30 (-7/+21) Days
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Index Procedure

Eligibility
Key inclusion criteria
Clinical

1. Subject must voluntarily sign and date the approved Informed Consent Form (ICF) prior
to collection of study data or performance of study 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: More than one target embolization
site may be treated per subject.

Angiographic

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.

Clinical
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 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.

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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Sydney Local Health District - Camperdown
Recruitment hospital [2] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
C. R. Bard
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04090320
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Holden, FRANZCR
Address 0 0
Auckland City Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David Stanfield
Address 0 0
Country 0 0
Phone 0 0
(480) 350-6467
Fax 0 0
Email 0 0
David.Stanfield@bd.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04090320