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Perfusion Angiography and Critical Limb Ischemia.


- candidate number22519
- NTR NumberNTR5338
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jul-2015
- Secondary IDsW15_144# 15.0172 METC van het AMC
- Public TitlePerfusion Angiography and Critical Limb Ischemia.
- Scientific TitleEvaluation of Perfusion Angiography to be used during interventions in Critical Limb Ischemia patients.
- ACRONYMPALI
- hypothesisPerfusion Angiography, in relation with known parameters, describes the ultimate prognostic model in revascularized Critical Limb Ischemia patients.
- Healt Condition(s) or Problem(s) studiedCritical limb ischemia
- 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-aug-2015
- planned closingdate1-aug-2017
- Target number of participants120
- InterventionsThe 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.
- Primary outcomeTo 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 outcomeCorrelation between perfusion angiography and non-invasive measurements, differences in perfusion between diabetic and non-diabetic patients.
- TimepointsThe total duration of the study is expected to take approximately 2 years.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. Jim A Reekers
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Jim A Reekers
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Philips Medical Systems Nederland B.V.
- PublicationsIt is the intention of the investigator and sponsor to submit the clinical study data for publication.
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD30-jul-2015 - 17-okt-2015


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