No registrations found.
ID
Source
Brief title
Health condition
Critical Limb Ischemia (CLI)
Sponsors and support
Intervention
Outcome measures
Primary outcome
To study the role of pre- and post- angioplasty perfusion data in patients with critical limb ischemia in relation to clinical outcome at 12 months.
Secondary outcome
Correlation between perfusion angiography and non-invasive measurements, differences in perfusion between diabetic and non-diabetic patients.
Background summary
This evaluation investigates the prognostic value of perfusion angiography software to be used during CLI interventions. Quantitative analysis of the software data will determine how well the software predicts the clinical outcome of CLI patients. Also, patient demographics and non-invasive measurements (standard of care treatment) will be collected in this study.
Study objective
Perfusion Angiography, in relation with known parameters, describes the ultimate prognostic model in revascularized Critical Limb Ischemia patients.
Study design
The total duration of the study is expected to take approximately 2 years.
Intervention
The patient will undergo standard of care medical treatment for his or her CLI condition. During the procedure, the interventionalist will take runoffs of the affected leg and foot, before and after the revascularization procedure. The DSA of the foot, pre- and post, will be automatically processed in the perfusion angiography software solution and displayed on the workstation in the control room. Retrospectively, the data will be post-processed and quantitative analysis will take place. After the procedure is finished, the patient will go home. When the patient returns to the outpatient clinic (standard of care), healing of the wound will be logged.
Jim A Reekers
Academic Medical Center Meibergdreef 9 PO box 22660
Amsterdam 1100 DD
The Netherlands
Tel 0031-20-5663228
email:j.a.reekers@amc.uva.nl
Jim A Reekers
Academic Medical Center Meibergdreef 9 PO box 22660
Amsterdam 1100 DD
The Netherlands
Tel 0031-20-5663228
email:j.a.reekers@amc.uva.nl
Inclusion criteria
1. Critical limb ischemia according to consensus document with a non-healing ulcer or gangrene.
2. Duration of complaints > 2 weeks.
3. Scheduled for DSA with endovascular intervention below the knee.
Exclusion criteria
1. Critical limb ischemia due to acute arterial occlusion.
2. No options for infra-popliteal angioplasty.
3. Allergy to contrast.
4. inability to give informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5190 |
| NTR-old | NTR5338 |
| Other | METC van het AMC : W15_144# 15.0172 |