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The Dutch LimFlow registry; a clinical post marketing trial investigating the long term results after a Percutaneous Deep Vein Arterialization (LimFlow) in the treatment of no-option chronic limb threatening ischemia patient.

Dutch LimFlow Registry

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21714
Enrollment
50
Registered
2019-11-13
Start date
2020-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic limb threatening ischemia

Interventions

Percutaneous deep venous arterialization

Sponsors

LimFlow
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: I-1. Approved for the LimFlow procedure I-2. Subject is willing and has adequate support to comply with protocol requirements, including medication regimen and followup visits

Exclusion criteria

Exclusion criteria: E-1. Patient unable to give consent

Design outcomes

Primary

MeasureTime frame
Amputation-free survival at 24 months follow-up

Secondary

MeasureTime frame
Secondary objectives are to evaluate the long-term effect of pDVA on: - Complete wound healing - Primary and secondary patency - Limb salvage - Renal function - Quality of life - Long term cardial effect - Cost effectiveness

Contacts

Public ContactEline Huizing

Northwest Clinics

e.huizing@nwz.nl072 548 4444

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)