Who is sponsoring NCT04244370?

NCT04244370 is sponsored by C. R. Bard.

What drugs are being tested in NCT04244370?

Interventions in NCT04244370: Caterpillar™ Arterial Embolization Device.

What condition does NCT04244370 study?

NCT04244370 studies Embolization, Therapeutic.

Is NCT04244370 still recruiting?

NCT04244370 is currently completed. Last updated 25 July 2023.

Are results published for NCT04244370?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-07-25 · How we verify

NCT04244370: MONARCH

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Caterpillar™ Arterial Embolization Device Post-Market Study

Completed NA Results posted Last updated 25 July 2023

What this trial tests

NA trial testing Caterpillar™ Arterial Embolization Device in Embolization, Therapeutic in 50 participants. Completed in 12 August 2022.

Timeline

30 April 2020

Primary endpoint
13 August 2021

12 August 2022

Quick facts

Lead sponsor	C. R. Bard
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	30 April 2020
Primary completion	13 August 2021
Estimated completion	12 August 2022
Sites	11 locations across United States

Drugs / interventions tested

Caterpillar™ Arterial Embolization Device

Conditions studied

Embolization, Therapeutic — all drugs for Embolization, Therapeutic →

Sponsor

C. R. Bard — full company profile →

Who can join

18 and older, any sex, with Embolization, Therapeutic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Technical Success Primary · During the Index Procedure

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.

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	55

Freedom From Device-Related SAEs Primary · 30 (-7/+21) Days post Index Procedure

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

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	50

Time Point of Occlusion Secondary · During Index Procedure

The percentage of target embolization site(s) with occlusion at ≤1, ≤2, ≤3, ≤4, ≤5, ≤10 and \>10 minutes post-treatment.

≤1 minute

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	15

≤ 2 minutes

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	10

≤ 3 minutes

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	7

≤ 4 minutes

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	1

≤ 5 minutes

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	11

≤ 10 minutes

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	5

> 10 minutes

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	6

Freedom From Recanalization Secondary · 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure

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.

30-Day Follow-up

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	56

6-Month Follow-up

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	43

12-Month Follow-up

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	31

Freedom From Acute Migration Secondary · During Index Procedure

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.

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	62

Freedom From Non-Acute Migration Secondary · 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure

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.

30-Day Follow-up

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	62

6-Month Follow-up

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	47

12-Month Follow-up

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	34

Freedom From Device and/or Procedure-Related Adverse Events Secondary · 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index Procedure

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

30-Day Follow-up

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	42

6-Month Follow-up

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	31

12-Month Follow-up

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	23

Accuracy of Delivery Secondary · During Index Procedure

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

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	61

Ease of Trackability/Deliverability Secondary · During Index Procedure

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

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	61

Ease of Detachment Secondary · During Index Procedure

Ease of study device detachment as assessed by the Investigator.

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	62

Acceptability of Visibility Under Fluoroscopy Secondary · During Index Procedure

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

Group	Value	95% CI
Caterpillar™ Arterial Embolization Device	59

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Caterpillar™ Arterial Embolization Device

Serious: 11/50 (22%)

Deaths: 5/50

Serious adverse events (15 terms)

Reaction	System	Caterpillar™ Arterial Embo…
Sepsis	Infections and infestations	—
Obstruction Gastric	Gastrointestinal disorders	—
Acute Kidney Injury	Renal and urinary disorders	—
Pancytopenia	Blood and lymphatic system disorders	—
Ascites	Gastrointestinal disorders	—
Gastrointestinal Haemorrhage	Gastrointestinal disorders	—
Hepatic Cirrhosis	Hepatobiliary disorders	—
Cellulitis	Infections and infestations	—
Procedural Pain	Injury, poisoning and procedural complications	—
Breast Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Colorectal Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Hepatocellular Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	—
Hypotension	Vascular disorders	—
Hypokalaemia	Metabolism and nutrition disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	Caterpillar™ Arterial Embo…
Abdominal Pain	Gastrointestinal disorders	—
Urinary Tract Infection	Infections and infestations	—

Most-reported serious reactions: Sepsis, Obstruction Gastric, Acute Kidney Injury, Pancytopenia, Ascites, Gastrointestinal Haemorrhage, Hepatic Cirrhosis, Cellulitis.

Data from ClinicalTrials.gov NCT04244370 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04244370 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by C. R. Bard
Last refreshed: 25 July 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04244370.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04244370: MONARCH

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (15 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Embolization, Therapeutic

Other C. R. Bard trials

Verify against primary sources