|- candidate number||22519|
|- NTR Number||NTR5338|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-jul-2015|
|- Secondary IDs||W15_144# 15.0172 METC van het AMC|
|- Public Title||Perfusion Angiography and Critical Limb Ischemia.|
|- Scientific Title||Evaluation of Perfusion Angiography to be used during interventions in Critical Limb Ischemia patients.|
|- hypothesis||Perfusion Angiography, in relation with known parameters, describes the ultimate prognostic model in revascularized Critical Limb Ischemia patients.|
|- Healt Condition(s) or Problem(s) studied||Critical 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 criteria||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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-aug-2015|
|- planned closingdate||1-aug-2017|
|- Target number of participants||120|
|- Interventions||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.|
|- Primary outcome||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. |
|- Secondary outcome||Correlation between perfusion angiography and non-invasive measurements, differences in perfusion between diabetic and non-diabetic patients. |
|- Timepoints||The total duration of the study is expected to take approximately 2 years.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. Jim A Reekers|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Jim A Reekers|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Philips Medical Systems Nederland B.V.|
|- Publications||It is the intention of the investigator and sponsor to submit the clinical study data for publication.|
|- Brief summary||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.|
|- Main changes (audit trail)|
|- RECORD||30-jul-2015 - 17-okt-2015|