Evaluating a new catheter for treating blocked arteries in the legs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.