Peripheral Arterial Disease
Conditions
Keywords
peripheral artery disease (PAD) below-the-knee atherectomy
Brief summary
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.
Detailed 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 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.
Interventions
DEVICEAtherectomy
Directional atherectomy of lesions below the knee.
Sponsors
Avinger, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Target lesion in the infragenicular segment * At least 1 pedal vessel noted in the foot * Rutherford classification 3 to 6 * Willing to give informed consent
Exclusion criteria
* if female, is pregnant or breast feeding * has had surgery or endovascular procedure within 30 days prior to the index procedure * has planned surgery within 30 days after the index procedure * had a major bleeding event within 60 days prior to the index procedure * currently in the treatment phase of a drug or device trial * has anticipated life span of less than 1.5 years * is unwilling to present to the investigator at 30 days, 6 moths, or 1 year after the index procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Events | from procedure to 30 days post-procedure | freedom from cardiovascular-related events |
| Technical success | At 1 day post-procedure | defined as residual stenosis \< 50 percent after atherectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency | At 6 and 12 months post-procedure | change in peak systolic velocity ratio (PSVR) |
| Procedure success | At 1 day post-procedure | defined as residual stenosis \< 30 percent post adjunctive therapy |
| Rutherford Classificaiton | At 30 days, 6 months, and 1 year post-procedure | Change since index procedure |
| Ankle-Brachial Index (ABI) | At 6 and 12 months post-procedure | change since index procedure |
| Freedom from target vessel revascularization (TVR) | At 6 and 12 months post-procedure | revascularization needed further |
Countries
United States
Contacts
Primary ContactThomas Lawson, PhD
Backup ContactRuth Lira, BS
Outcome results
None listed