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Embolization, TherapeuticMONARCHNCT04244370

Caterpillar™ Arterial Embolization Device Post-Market Study

A study testing Caterpillar™ Arterial Embolization Device in people with Embolization, Therapeutic, run by C. R. Bard at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 in a real world, on-label application. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Embolization, Therapeutic
What is being tested?
Caterpillar™ Arterial Embolization Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
11 sitesUnited States
Study dates
30 Apr 2020to 12 Aug 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject or Legally Authorized Representative (LAR) must voluntarily sign and date the approved Informed Consent Form (ICF) prior to collection of study-specific data or performance of study-specific 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: Per Investigator discretion, up to five (5) Target Embolization Sites may be treated with up to ten (10) study devices 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.

Who cannot join

  • 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.
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  • 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 has planned use of anticoagulant (e.g. direct thrombin inhibitors, factor Xa inhibitors, vitamin K antagonists) or antiplatelet therapy 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Cardiothoracic and Vascular Surgeons

    Austin, Texas, 78756

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • University of Kansas Medical Center Research Institute

    Kansas City, Kansas, 66160

  • Baptist Hospital of Miami

    Miami, Florida, 33176

  • The Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin, 53226

  • University of Minnesota Medical Center - Fairview

    Minneapolis, Minnesota, 55455

  • Dignity Health/St. Joseph's & Medical Center

    Phoenix, Arizona, 85013

Other trials in United States

About this study

Official title: A Prospective, Multi-Center, Single-Arm, Real World Study Assessing the Clinical Use of the Caterpillar™ Arterial Embolization Device for Arterial Embolization in the Peripheral Vasculature (MONARCH)

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 in a real world, on-label application.

Read the detailed description

The post-market study is a prospective, multi-center, single-arm, real world study of the Caterpillar™ Arterial Embolization Device. Enrollment will continue until up to fifty (50) subjects have been treated with the Caterpillar™ Arterial Embolization Device at up to 20 investigational sites in the United States.

Being tested
Caterpillar™ Arterial Embolization Device
Keywords
Arterial Embolization, Vascular Plug

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caterpillar™ Arterial Embolization DeviceDevice

    Also called Caterpillar™ Micro (027), Caterpillar™ (038 & 056)

    Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.

Study groups in NCT04244370
Study groupRoleWhat they receive
Caterpillar™ Arterial Embolization DeviceExperimentalPlacement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).
Receives: Device: Caterpillar™ Arterial Embolization Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During the Index Procedure

  2. Freedom From Device-Related SAEs

    Freedom from device-related serious adverse events (SAE) through 30-day follow-up.

    Measured: 30 (-7/+21) Days post Index Procedure

Secondary outcomes (9)

  1. 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.

    Measured: During Index Procedure

  2. Freedom From Recanalization

    Freedom from clinically relevant recanalization of the target embolization site(s) through 30-days, 6 and 12-months follow-up as confirmed by the Investigator. Clinically relevant recanalization is defined as recanalization through the study device that requires a re-intervention.

    Measured: 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure

  3. Freedom From Acute Migration

    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.

    Measured: During Index Procedure

  4. Freedom From Non-Acute Migration

    Freedom from clinically relevant migration of the study device(s) through 30 day, 6 month and 12 month follow-up was reported by the Investigators. Clinically relevant migration is defined as migration of the study device from the target embolization site that requires intervention.

    Measured: 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure

  5. Freedom From Device and/or Procedure-Related Adverse Events

    Freedom from device and/or procedure-related adverse events (AE) through 30-days, 6 and 12-months follow-up.

    Measured: 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure

  6. Accuracy of Delivery

    Accurate delivery of the study device to the target embolization site as assessed by the Investigator.

    Measured: During Index Procedure

  7. Ease of Trackability/Deliverability

    Ease of study device trackability and deliverability as assessed by the Investigator.

    Measured: During Index Procedure

  8. Ease of Detachment

    Ease of study device detachment as assessed by the Investigator.

    Measured: During Index Procedure

  9. Acceptability of Visibility Under Fluoroscopy

    Acceptability of study device visibility under fluoroscopy as assessed by the Investigator.

    Measured: During Index Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2020
  2. Study start30 Apr 2020
  3. Primary completion13 Aug 2021
  4. Study completion12 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04244370
Sponsor's protocol ID
BPV-18-001
Acronym
MONARCH
Status last verified
Jul 2023
First submitted
24 Jan 2020
Last updated
25 Jul 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Caterpillar™ Arterial Embolization Device in people with Embolization, Therapeutic, run by C. R. Bard at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technical Success (time frame: During the Index Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04244370.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023; AzTrials last refreshed its copy on 29 Oct 2026.

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