Trial Outcomes & Findings for Caterpillar™ Arterial Embolization Device Post-Market Study (NCT NCT04244370)
NCT ID: NCT04244370
Last Updated: 2023-07-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
During the Index Procedure
Results posted on
2023-07-25
Participant Flow
Participant milestones
| Measure |
Caterpillar™ Arterial Embolization Device
Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).
Caterpillar™ Arterial Embolization Device: Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
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|---|---|
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Overall Study
STARTED
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50
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Overall Study
COMPLETED
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49
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Caterpillar™ Arterial Embolization Device Post-Market Study
Baseline characteristics by cohort
| Measure |
Caterpillar™ Arterial Embolization Device
n=50 Participants
Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).
Caterpillar™ Arterial Embolization Device: Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
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|---|---|
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Age, Continuous
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58.9 years
STANDARD_DEVIATION 14.51 • n=93 Participants
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Sex: Female, Male
Female
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25 Participants
n=93 Participants
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Sex: Female, Male
Male
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25 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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15 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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33 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=93 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Asian
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2 Participants
n=93 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Black or African American
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4 Participants
n=93 Participants
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Race (NIH/OMB)
White
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40 Participants
n=93 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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4 Participants
n=93 Participants
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Region of Enrollment
United States
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50 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: During the Index ProcedureSuccessful 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.
Outcome measures
| Measure |
Caterpillar™ Arterial Embolization Device
n=56 Target Embolization Sites
Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).
Caterpillar™ Arterial Embolization Device: Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
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|---|---|
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Technical Success
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55 Target Embolization Sites
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PRIMARY outcome
Timeframe: 30 (-7/+21) Days post Index ProcedureFreedom from device-related serious adverse events (SAE) through 30-day follow-up.
Outcome measures
| Measure |
Caterpillar™ Arterial Embolization Device
n=50 Participants
Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).
Caterpillar™ Arterial Embolization Device: Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
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|---|---|
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Freedom From Device-Related SAEs
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50 Participants
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SECONDARY outcome
Timeframe: During Index ProcedureThe percentage of target embolization site(s) with occlusion at ≤1, ≤2, ≤3, ≤4, ≤5, ≤10 and \>10 minutes post-treatment.
Outcome measures
| Measure |
Caterpillar™ Arterial Embolization Device
n=55 Target Embolization Sites (TESs)
Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).
Caterpillar™ Arterial Embolization Device: Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
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|---|---|
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Time Point of Occlusion
≤1 minute
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15 Target Embolization Sites (TESs)
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Time Point of Occlusion
≤ 2 minutes
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10 Target Embolization Sites (TESs)
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Time Point of Occlusion
≤ 3 minutes
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7 Target Embolization Sites (TESs)
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Time Point of Occlusion
≤ 4 minutes
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1 Target Embolization Sites (TESs)
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Time Point of Occlusion
≤ 5 minutes
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11 Target Embolization Sites (TESs)
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Time Point of Occlusion
≤ 10 minutes
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5 Target Embolization Sites (TESs)
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Time Point of Occlusion
> 10 minutes
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6 Target Embolization Sites (TESs)
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SECONDARY outcome
Timeframe: 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index ProcedurePopulation: Number of TESs analyzed at 6-Months and 12-Months differs from 30-Day follow-up due to subject discontinuation in the study
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.
Outcome measures
| Measure |
Caterpillar™ Arterial Embolization Device
n=56 Target Embolization Sites (TESs)
Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).
Caterpillar™ Arterial Embolization Device: Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
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|---|---|
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Freedom From Recanalization
30-Day Follow-up
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56 Target Embolization Sites (TESs)
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Freedom From Recanalization
6-Month Follow-up
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43 Target Embolization Sites (TESs)
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Freedom From Recanalization
12-Month Follow-up
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31 Target Embolization Sites (TESs)
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SECONDARY outcome
Timeframe: During Index ProcedureFreedom 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.
Outcome measures
| Measure |
Caterpillar™ Arterial Embolization Device
n=62 Target Embolization Sites (TESs)
Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).
Caterpillar™ Arterial Embolization Device: Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
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|---|---|
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Freedom From Acute Migration
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62 Target Embolization Sites (TESs)
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SECONDARY outcome
Timeframe: 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index ProcedurePopulation: Number of devices analyzed at 6-Months and 12-Months differs from 30-Day follow-up due to subject discontinuation in the study
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.
Outcome measures
| Measure |
Caterpillar™ Arterial Embolization Device
n=62 Devices
Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).
Caterpillar™ Arterial Embolization Device: Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
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|---|---|
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Freedom From Non-Acute Migration
30-Day Follow-up
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62 Devices
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Freedom From Non-Acute Migration
6-Month Follow-up
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47 Devices
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Freedom From Non-Acute Migration
12-Month Follow-up
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34 Devices
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SECONDARY outcome
Timeframe: 30 (-7/+21) days, 6 months (±30 days) and 12 months (±30 days) Post Index ProcedurePopulation: Number of Participants analyzed at 6-Months and 12-Months differs from 30-Day follow-up due to subject discontinuation
Freedom from device and/or procedure-related adverse events (AE) through 30-days, 6 and 12-months follow-up.
Outcome measures
| Measure |
Caterpillar™ Arterial Embolization Device
n=50 Participants
Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).
Caterpillar™ Arterial Embolization Device: Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
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|---|---|
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Freedom From Device and/or Procedure-Related Adverse Events
30-Day Follow-up
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42 Participants
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Freedom From Device and/or Procedure-Related Adverse Events
6-Month Follow-up
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31 Participants
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Freedom From Device and/or Procedure-Related Adverse Events
12-Month Follow-up
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23 Participants
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SECONDARY outcome
Timeframe: During Index ProcedureAccurate delivery of the study device to the target embolization site as assessed by the Investigator.
Outcome measures
| Measure |
Caterpillar™ Arterial Embolization Device
n=62 Target Embolization Sites (TESs)
Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).
Caterpillar™ Arterial Embolization Device: Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
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|---|---|
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Accuracy of Delivery
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61 Target Embolization Sites (TESs)
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SECONDARY outcome
Timeframe: During Index ProcedureEase of study device trackability and deliverability as assessed by the Investigator.
Outcome measures
| Measure |
Caterpillar™ Arterial Embolization Device
n=62 Target Embolization Sites (TESs)
Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).
Caterpillar™ Arterial Embolization Device: Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
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|---|---|
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Ease of Trackability/Deliverability
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61 Target Embolization Sites (TESs)
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SECONDARY outcome
Timeframe: During Index ProcedureEase of study device detachment as assessed by the Investigator.
Outcome measures
| Measure |
Caterpillar™ Arterial Embolization Device
n=62 Target Embolization Sites (TESs)
Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).
Caterpillar™ Arterial Embolization Device: Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
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|---|---|
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Ease of Detachment
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62 Target Embolization Sites (TESs)
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SECONDARY outcome
Timeframe: During Index ProcedureAcceptability of study device visibility under fluoroscopy as assessed by the Investigator.
Outcome measures
| Measure |
Caterpillar™ Arterial Embolization Device
n=63 Target Embolization Sites (TESs)
Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).
Caterpillar™ Arterial Embolization Device: Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
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|---|---|
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Acceptability of Visibility Under Fluoroscopy
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59 Target Embolization Sites (TESs)
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Adverse Events
Caterpillar™ Arterial Embolization Device
Serious events: 11 serious events
Other events: 6 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Caterpillar™ Arterial Embolization Device
n=50 participants at risk
Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).
Caterpillar™ Arterial Embolization Device: Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
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|---|---|
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Gastrointestinal disorders
Obstruction Gastric
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2.0%
1/50 • Number of events 1 • 12 months
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Renal and urinary disorders
Acute Kidney Injury
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2.0%
1/50 • Number of events 1 • 12 months
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Blood and lymphatic system disorders
Pancytopenia
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2.0%
1/50 • Number of events 1 • 12 months
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Gastrointestinal disorders
Ascites
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2.0%
1/50 • Number of events 1 • 12 months
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Gastrointestinal disorders
Gastrointestinal Haemorrhage
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2.0%
1/50 • Number of events 1 • 12 months
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Hepatobiliary disorders
Hepatic Cirrhosis
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2.0%
1/50 • Number of events 1 • 12 months
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Infections and infestations
Cellulitis
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2.0%
1/50 • Number of events 1 • 12 months
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Infections and infestations
Sepsis
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4.0%
2/50 • Number of events 2 • 12 months
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Injury, poisoning and procedural complications
Procedural Pain
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2.0%
1/50 • Number of events 1 • 12 months
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Metastatic
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2.0%
1/50 • Number of events 1 • 12 months
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal Cancer Metastatic
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2.0%
1/50 • Number of events 1 • 12 months
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular Carcinoma
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2.0%
1/50 • Number of events 1 • 12 months
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Respiratory, thoracic and mediastinal disorders
Respiratory Failure
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2.0%
1/50 • Number of events 1 • 12 months
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Vascular disorders
Hypotension
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2.0%
1/50 • Number of events 1 • 12 months
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Metabolism and nutrition disorders
Hypokalaemia
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2.0%
1/50 • Number of events 1 • 12 months
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Other adverse events
| Measure |
Caterpillar™ Arterial Embolization Device
n=50 participants at risk
Placement of the Caterpillar™ Arterial Embolization Device via percutaneous transcatheter embolization (PTE).
Caterpillar™ Arterial Embolization Device: Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
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|---|---|
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Gastrointestinal disorders
Abdominal Pain
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6.0%
3/50 • Number of events 3 • 12 months
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Infections and infestations
Urinary Tract Infection
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6.0%
3/50 • Number of events 3 • 12 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator seeking publication shall submit to Sponsor for review a draft of the proposed publication at least 60 days prior to submission of the draft for publication. Sponsor shall have the right to: (i) review and make editorial comments on any such proposed publication; and (ii) make any results from the Study known to its customers and governmental agencies prior to publication.
- Publication restrictions are in place
Restriction type: OTHER