Using the Pantheris SV System to treat peripheral artery disease
Assessment of the Utility of the Pantheris SV System
This study is testing a new catheter called Pantheris SV to see if it can help people with peripheral artery disease below the knee by improving blood flow and monitoring their recovery over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Avinger, Inc. Industry-sponsored |
| Locations | 2 sites (Grand Rapids, Michigan and 1 other locations) |
| Trial ID | NCT04793581 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Pantheris SV catheter for treating peripheral artery disease in arteries below the knee. It involves a single-arm approach where patients undergo directional atherectomy to restore blood flow, followed by monitoring for symptoms and adverse events at 30 days, 6 months, and 1 year post-procedure. The study aims to collect data on the percentage of stenosis before and after the procedure, as well as the safety and effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with specific lesions in the infragenicular segment and a Rutherford classification of 3 to 6.
Not a fit: Patients who are pregnant, have had recent surgeries, or have a life expectancy of less than 1.5 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this could improve blood flow and reduce symptoms for patients with peripheral artery disease.
How similar studies have performed: Other studies using atherectomy techniques have shown promise, suggesting potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Grand Rapids, Michigan and 1 other locations
- Advanced Cardiac and Vascular Centers — Grand Rapids, Michigan, United States (Recruiting)
- Eastlake Cardiovascular PC — Saint Clair Shores, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Thomas Lawson, PhD
- Email: tlawson@avinger.com
- Phone: 6502417030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.