Trial Outcomes & Findings for OptiCal COherence ToMography ABoard InformiNg AtherEctomy (NCT NCT01775410)
NCT ID: NCT01775410
Last Updated: 2021-04-21
Results Overview
Freedom from major adverse events (MAE) through 30 day follow-up: * Clinically driven target lesion revascularization (TLR) * Myocardial infarct (MI) * Cardiovascular related deaths * Unplanned, major index limb amputation * Device Related Events: * Clinically Significant Perforations * Clinically Significant Dissections * Clinically Significant Embolus * Pseudoaneurysm
TERMINATED
NA
4 participants
Through 30 day follow-up
2021-04-21
Participant Flow
Participant milestones
| Measure |
Wolverine System
Wolverine System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
OptiCal COherence ToMography ABoard InformiNg AtherEctomy
Baseline characteristics by cohort
| Measure |
Wolverine System
n=4 Participants
Wolverine System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Colombia
|
4 participants
n=99 Participants
|
|
Target lesion length in cm
|
8.5 cm
STANDARD_DEVIATION 1.7 • n=99 Participants
|
|
Vessel Luminal diameter in cm
|
3.8 cm
STANDARD_DEVIATION 0.65 • n=99 Participants
|
PRIMARY outcome
Timeframe: Through 30 day follow-upFreedom from major adverse events (MAE) through 30 day follow-up: * Clinically driven target lesion revascularization (TLR) * Myocardial infarct (MI) * Cardiovascular related deaths * Unplanned, major index limb amputation * Device Related Events: * Clinically Significant Perforations * Clinically Significant Dissections * Clinically Significant Embolus * Pseudoaneurysm
Outcome measures
| Measure |
Wolverine System
n=4 Participants
Wolverine System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries
|
|---|---|
|
Number of Participants With no Major Adverse Events
|
4 Participants
|
SECONDARY outcome
Timeframe: During interventional procedureTechnical success is defined as the percent of target lesions that has a residual diameter stenosis \< 50% post the Wolverine device alone as assessed by an independent review at the time of treatment using quantitative angiography or visual estimate
Outcome measures
| Measure |
Wolverine System
n=4 Participants
Wolverine System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries
|
|---|---|
|
Technical Success: Percent of Target Lesions That Have a Residual Diameter Stenosis < 50%
|
100 Percentage of target lesions
|
SECONDARY outcome
Timeframe: Day 0Outcome measures
| Measure |
Wolverine System
n=4 Participants
Wolverine System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries
|
|---|---|
|
Procedural Success: Percent of Target Lesions That Have Residual Diameter Stenosis ≤30% Post-Wolverine and Any Other Adjunctive Therapy
|
100 Percentage of target lesions
|
SECONDARY outcome
Timeframe: During interventional procedureA procedural emboli is defined as a new occlusion of any visualized runoff vessel which cannot be reversed with an intravascular vasodilator.
Outcome measures
| Measure |
Wolverine System
n=4 Participants
Wolverine System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries
|
|---|---|
|
Number of Participants With no Procedural Emboli
|
4 Participants
|
SECONDARY outcome
Timeframe: At 30 daysAnkle-Brachial Index (ABI) is the ratio of blood pressure in the lower legs to the blood pressure in the arms. It is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm. ABI \< 0.95 indicates arterial disease; ABI between 0.95 and 1.3 is considered normal (free from significant peripheral artery disease); ABI \> 1.3 is abnormal, and suggests calcification of the artery walls and incompressible vessels, indicating severe peripheral vascular disease.
Outcome measures
| Measure |
Wolverine System
n=4 Participants
Wolverine System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries
|
|---|---|
|
Ankle-Brachial Index (ABI) at 30 Days
|
1.32 Ratio
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: At 30 daysRutherford Classification is a commonly used clinical means for describing the degree of peripheral artery disease. Rutherford Classifications range from Class 0: Asymptomatic, to Class 6: Major Tissue Loss. A lower score is less severe disease and a higher score is more severe disease progression.
Outcome measures
| Measure |
Wolverine System
n=4 Participants
Wolverine System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries
|
|---|---|
|
Rutherford Classification at 30 Days Post-procedure
|
2.6 score on a scale
Standard Deviation 0.63
|
Adverse Events
Wolverine System
Serious adverse events
| Measure |
Wolverine System
n=4 participants at risk
Wolverine System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries
|
|---|---|
|
Vascular disorders
Dissection
|
50.0%
2/4 • Number of events 2
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60