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CATERPILLAR™ Arterial Embolization Device Study (CHRYSALIS)

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ClinicalTrials.gov Identifier: NCT04090320
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

Tracking Information
First Submitted Date  ICMJE September 12, 2019
First Posted Date  ICMJE September 16, 2019
Last Update Posted Date September 27, 2019
Actual Study Start Date  ICMJE September 25, 2019
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
  • Technical Success [ Time Frame: Index Procedure. ]
    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.
  • Freedom from Device-Related SAEs [ Time Frame: 30 (-7/+21) Days ]
    Freedom from Device-Related Serious Adverse Events (SAE) through 30 day follow-up.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
  • Primary Performance Endpoint [ Time Frame: Index Procedure. ]
    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.
  • Primary Safety Endpoint [ Time Frame: 30 (-7/+21) Days ]
    Freedom from Device-Related Serious Adverse Events (SAE) through 30 day follow-up.
Change History Complete list of historical versions of study NCT04090320 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2019)
  • Time Point of Occlusion [ Time Frame: Index Procedure ]
    The percentage of target embolization site(s) with occlusion at ≤1, ≤2, ≤3, ≤4, ≤5, ≤10 and >10 minutes post-treatment.
  • Freedom from Recanalization [ Time Frame: 30 (-7/+21) Days ]
    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.
  • Freedom from Migration [ Time Frame: 30 (-7/+21) Days ]
    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.
  • Freedom from Device and/or Procedure-Related Adverse Events [ Time Frame: 30 (-7/+21) Days ]
    Freedom from device and/or procedure-related adverse events (AE) through 30 day follow-up.
  • Investigator Satisfaction [ Time Frame: Index Procedure ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CATERPILLAR™ Arterial Embolization Device Study
Official Title  ICMJE 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)
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.
Detailed Description 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Embolization, Therapeutic
Intervention  ICMJE Device: CATERPILLAR™ Arterial Embolization Device
Placement of the CATERPILLAR™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
Other Names:
  • CATERPILLAR™ Micro (027)
  • CATERPILLAR™ (038 & 056)
Study Arms  ICMJE Experimental: CATERPILLAR™ Arterial Embolization Device
Placement of the CATERPILLAR™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).
Intervention: Device: CATERPILLAR™ Arterial Embolization Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Clinical Inclusion Criteria:

  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 Inclusion Criteria:

  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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Stanfield (480) 350-6467 David.Stanfield@bd.com
Listed Location Countries  ICMJE Australia,   New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04090320
Other Study ID Numbers  ICMJE BPV-16-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party C. R. Bard
Study Sponsor  ICMJE C. R. Bard
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Holden, FRANZCR Auckland City Hospital
PRS Account C. R. Bard
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP