Assessment of the Utility of the Pantheris Small Vessel (SV) System
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Peripheral Arterial Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Single-armMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a post-market, single-arm study of the optical coherence tomography (OCT)-guided directional atherectomy catheter, Pantheris SV. Patients presenting with reduced blood flow in the lower extremity arteries will under directional atherectomy, followed by adjunctive therapy as deemed necessary ...
This is a post-market, single-arm study of the optical coherence tomography (OCT)-guided directional atherectomy catheter, Pantheris SV. Patients presenting with reduced blood flow in the lower extremity arteries will under directional atherectomy, followed by adjunctive therapy as deemed necessary by the physician, and then adverse events and symptom resolution will be documented at 30 days, 6 months, and 1 year after the procedure. Primary safety endpoints are related to adverse events and will be assessed at the time of the procedure and at 30 days after the procedure. Effectiveness endpoints center on restoration of blood flow.
Tracking Information
- NCT #
- NCT04793581
- Collaborators
- Not Provided
- Investigators
- Study Chair: Jaafer Golzar, MD Avinger, Inc.
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