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This single center prospective, randomized study will be conducted to investigate plaque removal and luminal gain using CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy System (OAS) (St.Paul, MN) versus Medtronic's Hawkone Directional Atherectomy system (DAS) (Minneapolis, MN) assessed by angiography and Intravascular Ultrasound (IVUS) in patients diagnosed with symptomatic obstructive femoro-popliteal disease will be analyzed. Both devices have received clearance by the Food and Drug Administration (FDA) for use by the label indication.Subjects will be randomized in a 1:1 fashion to receive treatment with either OAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB) or DAS (using the Hawkone device) followed by DCB. Subjects in both arms will undergo IVUS before and after atherectomy, as well as at the conclusion of the procedure. Clinical data will be collected at baseline, immediately prior to the procedure, during and immediately after the procedures, and within 30 days, 6 and 12 months office visits after the procedure. Data may also be collected at office or hospital visits that are not scheduled but occur up to 12 months after the procedure, if they pertain to treatment related to the obstructive SFA disease. Data to be collected for this study includes demographics, medical history, procedural parameters and follow-up. The study will be conducted at one study center, 90 subjects will be enrolled in the trial with plan to accrue 60 subjects - 30 patients enrolled in the OAS arm and 30 patients enrolled in the DAS arm. The duration of the study is expected to be approximately 2 years from the date of first enrollment (1 year for enrollment of 60 subjects and a year for follow-up).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy (OAS) | Active Comparator | OAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB) |
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| Medtronic's Hawkone Directional Atherectomy system (DAS) | Active Comparator | DAS (using the Hawkone device) followed by DCB |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Minimal Luminal Area | To be measured via Intravasular Ultrasound (IVUS) before and after atherectomy | Day 0, Immediately before procedure, immediately after procedure |
| Change in Percentage Diameter Stenosis (%DS) | Angiographic measurements of diameter stenosis following atherectomy | Day 0, Immediately before and after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percentage Plaque Volume | To be measured and analyzed via Intravascular Ultrasound (IVUS) | Day 0, Immediately before procedure, immediately after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anvar Babaev, MD, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 23, 2020 |
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| Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device | 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. |
|
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Minimal Luminal Area | To be measured via Intravasular Ultrasound (IVUS) before and after atherectomy | Posted | Median | Inter-Quartile Range | mm^2 | Day 0, Immediately before procedure, immediately after procedure |
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| Primary | Change in Percentage Diameter Stenosis (%DS) | Angiographic measurements of diameter stenosis following atherectomy | Posted | Mean | Standard Deviation | %DS | Day 0, Immediately before and after procedure |
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| ||||||||||||||||||||||||||||||
| Secondary | Change in Percentage Plaque Volume | To be measured and analyzed via Intravascular Ultrasound (IVUS) | Posted | Median | Inter-Quartile Range | V/V% | Day 0, Immediately before procedure, immediately after procedure |
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1 year
regular investigator assessment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 29 | 12 | 29 | 3 | 29 |
| EG001 | 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. | 0 | 30 | 9 | 30 | 3 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina | Cardiac disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| PVD | Vascular disorders | Systematic Assessment |
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| HTN | Cardiac disorders | Systematic Assessment |
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| AFIB | Cardiac disorders | Systematic Assessment |
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| AORTIC STENOSIS | Cardiac disorders | Systematic Assessment |
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| COLITIS | Gastrointestinal disorders | Systematic Assessment |
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| PNEUMONIA, COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| PNEUMONIA, PLEURITIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| DIABETIS | Endocrine disorders | Systematic Assessment |
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| CARDIOMYOPATHY | Cardiac disorders | Systematic Assessment |
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| CHF | Cardiac disorders | Systematic Assessment |
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| MENINGIOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| STABLE ANGINA | Cardiac disorders | Systematic Assessment |
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| CHEST PAIN | Cardiac disorders | Systematic Assessment |
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| CAD, CABG | Cardiac disorders | Systematic Assessment |
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| CAD PCI | Cardiac disorders | Systematic Assessment |
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| CHEST PAIN PCI | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PVD | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anvar Babaev, MD, PhD | NYU Langone Health | 212-263-5656 | Anvar.Babaev@nyulangone.org |
| Jul 26, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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| Participants |
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