Trials / Recruiting
RecruitingNCT06264843
Peripheral Bypass Trial for Completion Control
Open, Prospective, Multicentre Study Addressing the Immediate Benefits and the Prognostic Value of Intraoperative Completion Control Following Infrainguinal Bypass Surgery in Chronic Limb-Threatening Ischemia (CLTI) Patients
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 450 (estimated)
- Sponsor
- Medistim ASA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MiraQ with Transit-Time Flow Measurement (TTFM) and L15 High Frequency Ultrasound (HFUS) probes | Identify and validate intraoperative TTFM and HFUS findings (e.g. threshold values of Mean Graft Flow (MGF), MGF capacity, flow curve pattern, morphological issues) |
Timeline
- Start date
- 2024-11-14
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2024-02-20
- Last updated
- 2025-10-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06264843. Inclusion in this directory is not an endorsement.