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The value of Perfusion Angiography in Critical Limb Ischemia


- candidate number27743
- NTR NumberNTR6615
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-aug-2017
- Secondary IDsNL59437.100.16 R16.072/REPEAT
- Public TitleThe value of Perfusion Angiography in Critical Limb Ischemia
- Scientific TitleReproducibility and reliability of Perfusion Angiography and prediction of wound healing in critical limb ischemia
- ACRONYMREPEAT
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedCritical limb ischemia, Perfusion angiography
- Inclusion criteria1. 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 criteria1. 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jul-2017
- planned closingdate1-jul-2018
- Target number of participants50
- InterventionsPerfusion 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.
- Primary outcomeA) Reproducibility and inter-rater reliability Perfusion Angiography
B) correlation between Perfusion Angiography and wound healing at 3 months in comparison to traditional DSA
- Secondary outcomeA) 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.
- TimepointsThe total duration of the study is expected to be 24 months.
- Trial web sitenone
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. Daniel A.F. van den Heuvel,
- CONTACT for SCIENTIFIC QUERIESDrs. Daniel A.F. van den Heuvel,
- Sponsor/Initiator St. Antonius Hospital
- Funding
(Source(s) of Monetary or Material Support)
Philips Medical Systems Nederland B.V.
- PublicationsData will be published in peer reviewed journal(s)
- Brief summaryPredicting 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.
- Main changes (audit trail)
- RECORD14-aug-2017 - 19-aug-2017


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