Serrantor OCT Study

Launched by CAGENT VASCULAR LLC · May 23, 2024

Keywords

ClinConnect Summary

The Serrantor OCT Study is a clinical trial designed to explore a new treatment called serration angioplasty for patients suffering from Critical Limb Ischemia (CLI), a serious condition that reduces blood flow to the legs and can lead to severe pain or even loss of limbs. This trial will specifically look at how this treatment works on arteries below the knee that may have hard, calcified plaque buildup.

To participate in this study, individuals must be over 18 years old and have a specific level of disease severity (Rutherford category 4-6) affecting their leg. Unfortunately, those with certain types of artery blockages or who have previously had stenting will not be eligible. The trial is not yet recruiting participants, but once it starts, those who join can expect to undergo treatment and be closely monitored by medical professionals to see how well the new approach works for improving their condition. The goal is to find out if this innovative procedure can help restore better blood flow and ultimately enhance patients' quality of life.

Gender

ALL

Eligibility 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