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NCT06434194 · ClinicalTrials.gov registry record · NA
Serrantor OCT Study
A NA study of Critical Limb Ischemia, sponsored by Cagent Vascular.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT06434194: Recruiting NA study of Critical Limb Ischemia, sponsored by Cagent Vascular.
NCT06434194 is a NA study of Critical Limb Ischemia that is actively recruiting participants, run by Cagent Vascular. The registered enrollment target is 60 participants, below the 88-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (32% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06434194, a NA study of Critical Limb Ischemia, is actively recruiting participants, sponsored by Cagent Vascular.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study Summary
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
Primary Outcome
Residual lumen volume stenosis derived by OCT comparing Serration Angioplasty and conventional plain balloon angioplasty (PTA) measured at 10-15min post procedure. The lesion segment is defined as the entire treated segment where the balloon has been inflated.
Conditions Studied
Interventions
- DEVICE Serranator PTA Serration Catheter
- DRUG PTA (Standard of Care)
Study Locations (2)
New York
- Columbia University - New York
- Weill Cornell Medical - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-10-31 |
| Est. Completion | 2025-06-01 |
| Phase | NA |
What NCT06434194 shows while recruiting
NCT06434194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 88-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (32% lower).
The record links to 1 condition, with Critical Limb Ischemia appearing as the primary indexed condition, and to 2 interventions - of which Serranator PTA Serration Catheter is the first listed.
NCT06434194 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06434194 about?
NCT06434194 is a clinical study titled "Serrantor OCT Study". TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
What is the current status of trial NCT06434194?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2024-10-31. Estimated completion is 2025-06-01.
What conditions does trial NCT06434194 study?
This clinical trial studies the following conditions: Critical Limb Ischemia.
What interventions are being tested in trial NCT06434194?
The interventions under investigation include: Serranator PTA Serration Catheter (DEVICE), PTA (Standard of Care) (DRUG).
Who is sponsoring clinical trial NCT06434194?
This trial is sponsored by Cagent Vascular, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06434194 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06434194's enrollment target sits among peer trials
60 6th of 18 higher than 13 of 18 other Critical Limb Ischemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Critical Limb Ischemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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