Trial Outcomes & Findings for Directional Versus Orbital Atherectomy Plaque Modification and Luminal Area Assessment of the Femoro-popliteal Artery Via Intravascular Ultrasound (NCT NCT03495453)
NCT ID: NCT03495453
Last Updated: 2023-12-26
Results Overview
To be measured via Intravasular Ultrasound (IVUS) before and after atherectomy
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
94 participants
Primary outcome timeframe
Day 0, Immediately before procedure, immediately after procedure
Results posted on
2023-12-26
Participant Flow
Participant milestones
| Measure |
CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy (OAS)
OAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB)
Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device: HawkOne Directional Atherectomy System (DAS) also is the small catheter with cutting device. Doctor slowly and smoothly advances it across the blockage in your artery and shaves the plaque from the vessel wall and collects it in the reservoir.
|
Medtronic's Hawkone Directional Atherectomy System (DAS)
DAS (using the Hawkone device) followed by DCB
Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS: Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is a small catheter with a diamond crown. The doctor inserts it at the groin and advances into the leg.The OAS works by spinning around inside the artery to "sand down" the buildup of material along the artery walls while leaving the healthy vessel behind.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy (OAS)
OAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB)
Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device: HawkOne Directional Atherectomy System (DAS) also is the small catheter with cutting device. Doctor slowly and smoothly advances it across the blockage in your artery and shaves the plaque from the vessel wall and collects it in the reservoir.
|
Medtronic's Hawkone Directional Atherectomy System (DAS)
DAS (using the Hawkone device) followed by DCB
Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS: Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is a small catheter with a diamond crown. The doctor inserts it at the groin and advances into the leg.The OAS works by spinning around inside the artery to "sand down" the buildup of material along the artery walls while leaving the healthy vessel behind.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Directional Versus Orbital Atherectomy Plaque Modification and Luminal Area Assessment of the Femoro-popliteal Artery Via Intravascular Ultrasound
Baseline characteristics by cohort
| Measure |
CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy (OAS)
n=30 Participants
OAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB)
Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device: HawkOne Directional Atherectomy System (DAS) also is the small catheter with cutting device. Doctor slowly and smoothly advances it across the blockage in your artery and shaves the plaque from the vessel wall and collects it in the reservoir.
|
Medtronic's Hawkone Directional Atherectomy System (DAS)
n=29 Participants
DAS (using the Hawkone device) followed by DCB
Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS: Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is a small catheter with a diamond crown. The doctor inserts it at the groin and advances into the leg.The OAS works by spinning around inside the artery to "sand down" the buildup of material along the artery walls while leaving the healthy vessel behind.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
n=5 Participants
|
72 years
n=7 Participants
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
29 participants
n=7 Participants
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0, Immediately before procedure, immediately after procedureTo be measured via Intravasular Ultrasound (IVUS) before and after atherectomy
Outcome measures
| Measure |
CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy (OAS)
n=29 Participants
OAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB)
Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device: HawkOne Directional Atherectomy System (DAS) also is the small catheter with cutting device. Doctor slowly and smoothly advances it across the blockage in your artery and shaves the plaque from the vessel wall and collects it in the reservoir.
|
Medtronic's Hawkone Directional Atherectomy System (DAS)
n=30 Participants
DAS (using the Hawkone device) followed by DCB
Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS: Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is a small catheter with a diamond crown. The doctor inserts it at the groin and advances into the leg.The OAS works by spinning around inside the artery to "sand down" the buildup of material along the artery walls while leaving the healthy vessel behind.
|
|---|---|---|
|
Change in Minimal Luminal Area
|
5.8 mm^2
Interval 4.7 to 8.4
|
4 mm^2
Interval 2.9 to 6.3
|
PRIMARY outcome
Timeframe: Day 0, Immediately before and after procedureAngiographic measurements of diameter stenosis following atherectomy
Outcome measures
| Measure |
CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy (OAS)
n=29 Participants
OAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB)
Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device: HawkOne Directional Atherectomy System (DAS) also is the small catheter with cutting device. Doctor slowly and smoothly advances it across the blockage in your artery and shaves the plaque from the vessel wall and collects it in the reservoir.
|
Medtronic's Hawkone Directional Atherectomy System (DAS)
n=30 Participants
DAS (using the Hawkone device) followed by DCB
Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS: Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is a small catheter with a diamond crown. The doctor inserts it at the groin and advances into the leg.The OAS works by spinning around inside the artery to "sand down" the buildup of material along the artery walls while leaving the healthy vessel behind.
|
|---|---|---|
|
Change in Percentage Diameter Stenosis (%DS)
|
39.5 %DS
Standard Deviation 14.2
|
69.8 %DS
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: Day 0, Immediately before procedure, immediately after procedureTo be measured and analyzed via Intravascular Ultrasound (IVUS)
Outcome measures
| Measure |
CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy (OAS)
n=29 Participants
OAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB)
Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device: HawkOne Directional Atherectomy System (DAS) also is the small catheter with cutting device. Doctor slowly and smoothly advances it across the blockage in your artery and shaves the plaque from the vessel wall and collects it in the reservoir.
|
Medtronic's Hawkone Directional Atherectomy System (DAS)
n=30 Participants
DAS (using the Hawkone device) followed by DCB
Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS: Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is a small catheter with a diamond crown. The doctor inserts it at the groin and advances into the leg.The OAS works by spinning around inside the artery to "sand down" the buildup of material along the artery walls while leaving the healthy vessel behind.
|
|---|---|---|
|
Change in Percentage Plaque Volume
|
66.5 V/V%
Interval 61.8 to 73.2
|
75.6 V/V%
Interval 69.9 to 81.8
|
Adverse Events
CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy (OAS)
Serious events: 12 serious events
Other events: 3 other events
Deaths: 0 deaths
Medtronic's Hawkone Directional Atherectomy System (DAS)
Serious events: 9 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy (OAS)
n=29 participants at risk
OAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB)
Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device: HawkOne Directional Atherectomy System (DAS) also is the small catheter with cutting device. Doctor slowly and smoothly advances it across the blockage in your artery and shaves the plaque from the vessel wall and collects it in the reservoir.
|
Medtronic's Hawkone Directional Atherectomy System (DAS)
n=30 participants at risk
DAS (using the Hawkone device) followed by DCB
Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS: Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is a small catheter with a diamond crown. The doctor inserts it at the groin and advances into the leg.The OAS works by spinning around inside the artery to "sand down" the buildup of material along the artery walls while leaving the healthy vessel behind.
|
|---|---|---|
|
Cardiac disorders
Angina
|
6.9%
2/29 • 1 year
regular investigator assessment
|
3.3%
1/30 • 1 year
regular investigator assessment
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/29 • 1 year
regular investigator assessment
|
3.3%
1/30 • 1 year
regular investigator assessment
|
|
Vascular disorders
PVD
|
3.4%
1/29 • 1 year
regular investigator assessment
|
0.00%
0/30 • 1 year
regular investigator assessment
|
|
Cardiac disorders
HTN
|
3.4%
1/29 • 1 year
regular investigator assessment
|
0.00%
0/30 • 1 year
regular investigator assessment
|
|
Cardiac disorders
AFIB
|
0.00%
0/29 • 1 year
regular investigator assessment
|
3.3%
1/30 • 1 year
regular investigator assessment
|
|
Cardiac disorders
AORTIC STENOSIS
|
3.4%
1/29 • 1 year
regular investigator assessment
|
0.00%
0/30 • 1 year
regular investigator assessment
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/29 • 1 year
regular investigator assessment
|
3.3%
1/30 • 1 year
regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA, COPD
|
0.00%
0/29 • 1 year
regular investigator assessment
|
3.3%
1/30 • 1 year
regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA, PLEURITIS
|
0.00%
0/29 • 1 year
regular investigator assessment
|
3.3%
1/30 • 1 year
regular investigator assessment
|
|
Endocrine disorders
DIABETIS
|
3.4%
1/29 • 1 year
regular investigator assessment
|
0.00%
0/30 • 1 year
regular investigator assessment
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.00%
0/29 • 1 year
regular investigator assessment
|
3.3%
1/30 • 1 year
regular investigator assessment
|
|
Cardiac disorders
CHF
|
3.4%
1/29 • 1 year
regular investigator assessment
|
0.00%
0/30 • 1 year
regular investigator assessment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MENINGIOMA
|
0.00%
0/29 • 1 year
regular investigator assessment
|
3.3%
1/30 • 1 year
regular investigator assessment
|
|
Cardiac disorders
STABLE ANGINA
|
3.4%
1/29 • 1 year
regular investigator assessment
|
0.00%
0/30 • 1 year
regular investigator assessment
|
|
Cardiac disorders
CHEST PAIN
|
3.4%
1/29 • 1 year
regular investigator assessment
|
0.00%
0/30 • 1 year
regular investigator assessment
|
|
Cardiac disorders
CAD, CABG
|
3.4%
1/29 • 1 year
regular investigator assessment
|
3.3%
1/30 • 1 year
regular investigator assessment
|
|
Cardiac disorders
CAD PCI
|
3.4%
1/29 • 1 year
regular investigator assessment
|
0.00%
0/30 • 1 year
regular investigator assessment
|
|
Cardiac disorders
CHEST PAIN PCI
|
3.4%
1/29 • 1 year
regular investigator assessment
|
0.00%
0/30 • 1 year
regular investigator assessment
|
Other adverse events
| Measure |
CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy (OAS)
n=29 participants at risk
OAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB)
Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device: HawkOne Directional Atherectomy System (DAS) also is the small catheter with cutting device. Doctor slowly and smoothly advances it across the blockage in your artery and shaves the plaque from the vessel wall and collects it in the reservoir.
|
Medtronic's Hawkone Directional Atherectomy System (DAS)
n=30 participants at risk
DAS (using the Hawkone device) followed by DCB
Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS: Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is a small catheter with a diamond crown. The doctor inserts it at the groin and advances into the leg.The OAS works by spinning around inside the artery to "sand down" the buildup of material along the artery walls while leaving the healthy vessel behind.
|
|---|---|---|
|
Vascular disorders
PVD
|
10.3%
3/29 • 1 year
regular investigator assessment
|
10.0%
3/30 • 1 year
regular investigator assessment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place