The first objective is to determine the reproducibility and reliability of Perfusion Angiography. The second is to investigate the predictive value of Perfusion Angiography for wound healing in Critical Limb Ischemia.
ID
Bron
Verkorte titel
Aandoening
Critical Limb Ischemia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
A) Reproducibility and inter-rater reliability Perfusion Angiography<br>
B) correlation between Perfusion Angiography and wound healing at 3 months in comparison to traditional DSA
Achtergrond van het onderzoek
Predicting the success rate of wound healing in CLI is difficult. Currently applied methods do not correlate well with the clinical situation and are not applicable during revascularization procedures.
This study investigates the reproducibility and reliability of Perfusion Angiography and the prognostic value in predicting wound healing.
Doel van het onderzoek
The first objective is to determine the reproducibility and reliability of Perfusion Angiography. The second is to investigate the predictive value of Perfusion Angiography for wound healing in Critical Limb Ischemia.
Onderzoeksopzet
The total duration of the study is expected to be 24 months.
Onderzoeksproduct en/of interventie
Perfusion Angiography will be performed during revascularization procedures. Extra runs will be performed to investigate reproducibility and the correlation with wound healing. Perfusion Angiography results will be reviewed in retrospect so that the revascularization procedures are not influenced by the results.
Publiek
Koekoekslaan 1
Nieuwegein 3430 EM
The Netherlands
0031 88 320 3000
d.van.den.heuvel@antoniusziekenhuis.nl
Wetenschappelijk
Koekoekslaan 1
Nieuwegein 3430 EM
The Netherlands
0031 88 320 3000
d.van.den.heuvel@antoniusziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Diagnosed with CLI according to the TASC II Working Group criteria
2. Present with non-healing ulcers or gangrene (RB 5-6)
3. Older than 18 years
4. No or adequately treated inflow disease
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Severe renal failure defined as an eGFR <30 mL/1.73 m2
2. Severe allergy to contrast medium with an absolute contra-indication
3. Pregnancy
4. Scheduled or anticipated major amputation (above the ankle)
5. Inability to position the foot in the footrest used for Perfusion Angiography
6. Inability to give informed consent
7. Distal embolization after treatment of inflow vessels
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6273 |
| NTR-old | NTR6615 |
| CCMO | NL59437.100.16 |
| OMON | NL-OMON43228 |