Recruiting
Serrantor OCT Study
Cagent Vascular LLC · NCT06434194
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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 19+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 60
- US sites recruiting
- 2
- Study start
- October 31, 2024
- Record last updated
- May 18, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
Being studied: Serranator PTA Serration Catheter; PTA (Standard of Care)
Conditions: Critical Limb Ischemia
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Columbia University
New York, NY 10032
Site contact: K Dalton
Weill Cornell Medical
New York, NY 10065
Site contact: R Chu
Study contacts (from the official record)
- Feeny · 4197878496 · kjclinconsulting@gmail.com
- Wittwer · twittwer@mededge.io