Follow-up Study of the Serranator PTA Serration Balloon Catheter

What is the Purpose of this Study?

This study focuses on people who have peripheral artery disease or a dysfunctional arteriovenous fistula and will be treated as part of routine standard care with a device called the Serranator PTA Serration Balloon Catheter (Serranator). The Serranator is approved by the U.S. Food and Drug Administration (FDA). It is a type of balloon catheter that includes the technology to score the lesion to enhance the balloon effect, which helps open up the blood vessel. The study will collect information about the safety and effectiveness of the Serranator; the data will be included in a registry about the device. Study procedures include collecting post-surgery information from medical records about how well the surgery using the Serranator PTA Serration Balloon Catheter worked for the procedure and how the patient felt following the surgery. Researchers aim to confirm the performance and safety of the Serranator when used to treat a lesion in the blood vessel. This will be evaluated as a part of standard of care with an angiogram (a type of imaging to view the vessels and determine how it worked). Safety will also be assessed by tracking adverse events (unwanted effects or injuries).


Eligibility

  • * Subject requires angioplasty
  • * Subject has a lesion in the iliac, femoral, iliofemoral, popliteal artery, or obstructive lesion of native or synthetic arteriovenous dialysis fistulae as per the product indications for use
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

POst-Market ClINical Follow-up STudy oF the SerranatOR PTA Serration Balloon CathEter

Study Details
Disease Type/Condition

Other

Principal Investigator

Baril, Donald

Age Group

Adult

Phase

N/A

IRB Number

STUDY00003830

ClinicalTrials.gov ID

NCT03538392

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Baril, Donald

Age Group

Adult

Phase

N/A

IRB Number

NIS-CSP0696

ClinicalTrials.gov ID

NCT03538392

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org