Evaluating a new catheter for treating blocked arteries in the legs
Serranator OCT: Understanding the Mechanism of Action of Serration Angioplasty by Serranator Versus Conventional Balloon Angioplasty for below-the Knee (BTK) Artery Disease Using Optical Coherence Tomography (OCT)
This study is testing a new catheter to see if it can help improve blood flow in patients with blocked leg arteries compared to standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Cagent Vascular LLC Industry-sponsored |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT06434194 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective randomized control trial designed to assess the effectiveness of the Serrantor PTA Serration Catheter in treating critical limb ischemia in patients with varying degrees of calcified plaque in below-the-knee arteries. Participants will be randomly assigned to receive either the serration catheter intervention or standard care. The study aims to determine if this new approach can improve blood flow and patient outcomes compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with Rutherford clinical category 4-6 in the target limb.
Not a fit: Patients with de novo or restenotic stenosis or occlusion, or those with lesions outside the specified criteria, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve blood flow and reduce complications for patients suffering from critical limb ischemia.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes for patients with critical limb ischemia.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Rutherford clinical category 4-6 of the target limb * Age of subjects is \>18 years old * Patients has given informed consent to participate in this study Exclusion Criteria: * De novo or restenotic (without prior stent) stenosis (≥70%) or occlusion * Target lesion is in the BTK arteries, including below the knee popliteal, tibioperoneal trunk, tibial, peroneal, and pedal arteries. * Angiographic visual estimated reference vessel diameter is between 2.0 and 5.0 mm. * Lesion length less than 220 mm
Where this trial is running
New York, New York and 1 other locations
- Columbia University — New York, New York, United States (Recruiting)
- Weill Cornell Medical — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Feeny
- Email: kjclinconsulting@gmail.com
- Phone: 4197878496
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.