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NCT03495453 · ClinicalTrials.gov registry record · NA
Directional Versus Orbital Atherectomy Plaque Modification and Luminal Area Assessment of the Femoro-popliteal Artery Via Intravascular Ultrasound
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 94
- Enrollment target
NCT03495453 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 94 participants.
The verdict
NCT03495453, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 94 participants
- Enrollment target
Study Summary
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).
Interventions
- DEVICE Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS
- DEVICE Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2018-03-23 |
| Est. Completion | 2023-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03495453
The ClinicalTrials.gov registry entry for NCT03495453 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS is the first listed.
NCT03495453 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03495453 about?
NCT03495453 is a clinical study titled "Directional Versus Orbital Atherectomy Plaque Modification and Luminal Area Assessment of the Femoro-popliteal Artery Via Intravascular Ultrasound". 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 angio...
What is the current status of trial NCT03495453?
This trial is currently completed. It is a NA study. The enrollment target is 94 participants. The study started on 2018-03-23. Estimated completion is 2023-08-31.
What interventions are being tested in trial NCT03495453?
The interventions under investigation include: Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS (DEVICE), Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device (DEVICE).
Who is sponsoring clinical trial NCT03495453?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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