No registrations found.
ID
Source
Brief title
Health condition
Critical Limb Ischemia
Sponsors and support
Intervention
Outcome measures
Primary outcome
A) Reproducibility and inter-rater reliability Perfusion Angiography
B) correlation between Perfusion Angiography and wound healing at 3 months in comparison to traditional DSA
Secondary outcome
A) correlation between Perfusion Angiography and wound healing at 6 months in comparison to traditional DSA
B) gaining insights in the flow redistribution during revascularization procedures.
Background summary
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.
Study objective
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.
Study design
The total duration of the study is expected to be 24 months.
Intervention
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.
Koekoekslaan 1
Nieuwegein 3430 EM
The Netherlands
0031 88 320 3000
d.van.den.heuvel@antoniusziekenhuis.nl
Koekoekslaan 1
Nieuwegein 3430 EM
The Netherlands
0031 88 320 3000
d.van.den.heuvel@antoniusziekenhuis.nl
Inclusion criteria
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
Exclusion criteria
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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6273 |
| NTR-old | NTR6615 |
| CCMO | NL59437.100.16 |
| OMON | NL-OMON43228 |