RECRUITINGINTERVENTIONAL
Assessment of the Utility of the Pantheris Small Vessel (SV) System
Assessment of the Utility of the Pantheris SV System
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
Atherectomy
Directional atherectomy of lesions below the knee.
Locations (2)
Advanced Cardiac and Vascular Centers
Grand Rapids, Michigan, United States
Eastlake Cardiovascular PC
Saint Clair Shores, Michigan, United States