Perfusion Angiography, in relation with known parameters, describes the ultimate prognostic model in revascularized Critical Limb Ischemia patients.
ID
Bron
Verkorte titel
Aandoening
Critical Limb Ischemia (CLI)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Perfusion Angiography, in relation with known parameters, describes the ultimate prognostic model in revascularized Critical Limb Ischemia patients.
Onderzoeksopzet
The total duration of the study is expected to take approximately 2 years.
Onderzoeksproduct en/of interventie
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.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL5190 |
NTR-old | NTR5338 |
Ander register | METC van het AMC : W15_144# 15.0172 |