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A single-arm study to assess the utility of the Pantheris SV catheter in addressing peripheral artery disease in arteries located below the knee. Data will be collected on the percent stenosis pre- and post-atherectomy and then symptoms and adverse events noted at 30 days, 6 months, and 1 year after the procedure.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Other | Single-arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atherectomy | Device | Directional atherectomy of lesions below the knee. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Events | freedom from cardiovascular-related events | from procedure to 30 days post-procedure |
| Technical success | defined as residual stenosis < 50 percent after atherectomy | At 1 day post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure success | defined as residual stenosis < 30 percent post adjunctive therapy | At 1 day post-procedure |
| Freedom from target vessel revascularization (TVR) | revascularization needed further |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Lawson, PhD | Contact | 6502417030 | tlawson@avinger.com | |
| Ruth Lira, BS | Contact | 6502417031 | rlira@avinger.com |
| Name | Affiliation | Role |
|---|---|---|
| Jaafer Golzar, MD | Avinger, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Cardiac and Vascular Centers | Recruiting | Grand Rapids | Michigan | 49525 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30499198 | Result | Khalili H, Jeon-Slaughter H, Armstrong EJ, Baskar A, Tejani I, Shammas NW, Prasad A, Abu-Fadel M, Brilakis ES, Banerjee S. Atherectomy in below-the-knee endovascular interventions: One-year outcomes from the XLPAD registry. Catheter Cardiovasc Interv. 2019 Feb 15;93(3):488-493. doi: 10.1002/ccd.27897. Epub 2018 Nov 30. | |
| 28393673 | Result |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D017073 | Atherectomy |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
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Single-arm
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| At 6 and 12 months post-procedure |
| Primary patency | change in peak systolic velocity ratio (PSVR) | At 6 and 12 months post-procedure |
| Ankle-Brachial Index (ABI) | change since index procedure | At 6 and 12 months post-procedure |
| Rutherford Classificaiton | Change since index procedure | At 30 days, 6 months, and 1 year post-procedure |
| Eastlake Cardiovascular PC | Recruiting | Saint Clair Shores | Michigan | 48080 | United States |
|
| Schwindt AG, Bennett JG Jr, Crowder WH, Dohad S, Janzer SF, George JC, Tedder B, Davis TP, Cawich IM, Gammon RS, Muck PE, Pigott JP, Dishmon DA, Lopez LA, Golzar JA, Chamberlin JR, Moulton MJ, Zakir RM, Kaki AK, Fishbein GJ, McDaniel HB, Hezi-Yamit A, Simpson JB, Desai A. Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the EValuatIon of the PantheriS OptIcal COherence Tomography ImagiNg Atherectomy System for Use in the Peripheral Vasculature (VISION) Study. J Endovasc Ther. 2017 Jun;24(3):355-366. doi: 10.1177/1526602817701720. Epub 2017 Apr 10. |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D014656 |
| Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |