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New treatment option for Peripheral Arterial Disease
Official title Assessment of the Utility of the Pantheris Small Vessel (SV) System
ClinicalTrials.gov ID: NCT04793581
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Grand Rapids, Michigan, United States
- Saint Clair Shores, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grand Rapids, Michigan, United States; Saint Clair Shores, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.