Trials / Recruiting
RecruitingNCT06434194
Serrantor OCT Study
Serranator OCT: Understanding the Mechanism of Action of Serration Angioplasty by Serranator Versus Conventional Balloon Angioplasty for below-the Knee (BTK) Artery Disease Using Optical Coherence Tomography (OCT)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Cagent Vascular LLC · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Serranator PTA Serration Catheter | The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications. |
| DRUG | PTA (Standard of Care) | A percutaneous transluminal angioplasty catheter will be used to treat the target lesion. |
Timeline
- Start date
- 2024-10-31
- Primary completion
- 2025-06-01
- Completion
- 2025-06-01
- First posted
- 2024-05-30
- Last updated
- 2025-05-18
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06434194. Inclusion in this directory is not an endorsement.