Registry for the Serranator device in treating peripheral artery disease and dialysis fistula issues
POst-Market ClINical Follow-up STudy oF the SerranatOR PTA Serration Balloon CathEter
This study is collecting information on how well the Serranator device works for people with peripheral artery disease and dialysis fistula problems while they receive standard treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cagent Vascular LLC Industry-sponsored |
| Locations | 19 sites (Scottsdale, Arizona and 18 other locations) |
| Trial ID | NCT06687590 on ClinicalTrials.gov |
What this trial studies
This registry collects observational data on the safety and performance of the Serranator® device used in treating peripheral artery disease (PAD) and dysfunctional arteriovenous dialysis fistulae. Participants will receive peripheral balloon angioplasty as part of their standard care, and the data gathered will help evaluate the device's effectiveness in real-world scenarios. The study aims to provide clinical evidence that can support future evaluations of the Serranator® in medical practice.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with claudication or critical limb-threatening ischemia due to PAD or dysfunctional dialysis fistulae.
Not a fit: Patients with medical conditions that contraindicate the use of the Serranator® or those enrolled in other conflicting studies may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance treatment options for patients with PAD and dialysis-related vascular issues.
How similar studies have performed: While this registry approach is observational, similar studies evaluating device performance in real-world settings have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects intended to be treated with Serranator® for de-novo or restenotic lesions of the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries or dysfunctional native or synthetic arteriovenous dialysis fistulae. * Subjects presenting with claudication or critical limb-threatening ischemia (CLTI) by Rutherford Clinical Category 3, 4, 5, or 6 of the target limb. * Age of subject is \> 18. * Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form. Exclusion Criteria: * Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Serranator® as per Instructions for Use (IFU) or investigator's opinion. * Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
Where this trial is running
Scottsdale, Arizona and 18 other locations
- HonorHealth — Scottsdale, Arizona, United States (Recruiting)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- Hartford HealthCare — Hartford, Connecticut, United States (Recruiting)
- MedStar Washington Hospital / MedStar Montgomery — Washington D.C., District of Columbia, United States (Recruiting)
- Manatee Memorial — Bradenton, Florida, United States (Recruiting)
- Radiology and Imaging Specialists — Lakeland, Florida, United States (Recruiting)
- Henry Ford Health — Detroit, Michigan, United States (Recruiting)
- Barnes Jewish — St Louis, Missouri, United States (Recruiting)
- Atlantic Medical Imaging — Brick, New Jersey, United States (Recruiting)
- Virtua Health — Marlton, New Jersey, United States (Recruiting)
- Northwell — New Hyde Park, New York, United States (Recruiting)
- Ohio State University Medical Center — Columbus, Ohio, United States (Recruiting)
- Miami Valley Hospital — Dayton, Ohio, United States (Recruiting)
- Oregon Health & Sciences University — Portland, Oregon, United States (Recruiting)
- Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States (Active_not_recruiting)
- Jefferson Einstein — Philadelphia, Pennsylvania, United States (Recruiting)
- Brown Health — Providence, Rhode Island, United States (Recruiting)
- Prisma Health — Greenville, South Carolina, United States (Recruiting)
- Aurora St. Luke's — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Alexis Shewfelt
- Email: ashewfelt33@cagentvascular.com
- Phone: 6502086743
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.