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NCT06687590 · ClinicalTrials.gov registry record
Serranator POINT FORCE Registry
A clinical trial of Peripheral Artery Disease (PAD) and Dysfunctional AV Fistula, sponsored by Cagent Vascular.
- Recruiting
- Registry status
- 500
- Enrollment target
- 1
- Study location
NCT06687590: Recruiting study of Peripheral Artery Disease (PAD) and Dysfunctional AV Fistula, sponsored by Cagent Vascular.
NCT06687590 is a study of Peripheral Artery Disease (PAD) and Dysfunctional AV Fistula that is actively recruiting participants, run by Cagent Vascular. The registered enrollment target is 500 participants, above the 189-participant average among 5 other Peripheral Artery Disease (PAD) trials with a reported enrollment target (165% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06687590, a study of Peripheral Artery Disease (PAD) and Dysfunctional AV Fistula, is actively recruiting participants, sponsored by Cagent Vascular.
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario. The data and conclusions derived from this study will be used to provide clinical evidence for the clinical evaluation process.
Primary Outcome
Device Success defined as the achievement of successful delivery, balloon inflation and deflation, and retrieval of the study device(s) with a post- Serranator® residual stenosis of ≤30% by angiographic core laboratory assessment at the intended target lesion.
Conditions Studied
Interventions
- DEVICE Peripheral balloon angioplasty
Study Locations (1)
Texas
- UT Southwestern - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2025-01-22 |
| Est. Completion | 2026-12-31 |
What NCT06687590 shows while recruiting
NCT06687590 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 189-participant average among 5 other Peripheral Artery Disease (PAD) trials with a reported enrollment target (165% higher).
The record links to 3 conditions, with Peripheral Artery Disease (PAD) appearing as the primary indexed condition, and to 1 intervention - of which Peripheral balloon angioplasty is the first listed.
NCT06687590 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06687590 about?
NCT06687590 is a clinical study titled "Serranator POINT FORCE Registry". The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario. The dat...
What is the current status of trial NCT06687590?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2025-01-22. Estimated completion is 2026-12-31.
What conditions does trial NCT06687590 study?
This clinical trial studies the following conditions: Peripheral Artery Disease (PAD), Dysfunctional AV Fistula, Dysfunctional AV Graft.
What interventions are being tested in trial NCT06687590?
The interventions under investigation include: Peripheral balloon angioplasty (DEVICE).
Who is sponsoring clinical trial NCT06687590?
This trial is sponsored by Cagent Vascular, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06687590 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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