Currently accepted at: JMIR Research Protocols
Date Submitted: Feb 2, 2018
Open Peer Review Period: Feb 7, 2018 - Feb 21, 2018
Date Accepted: Oct 8, 2018
(closed for review but you can still tweet)
INDIAN REGISTRY: The INDigo system In Acute lower limb malperfusioN
Acute lower limb ischaemia (ALLI) poses a major threat to limb survival. For many years surgical thrombo-embolectomy was the mainstay of treatment. Recent years have brought an endovascular revolution in the management of acute lower limb ischaemia. It seems that the newly designed endovascular thrombectomy devices may shift treatment recommendations towards endovascular options. This protocol study aims to collect evidence supporting the latest hypothesis.
The devices under investigation are the Penumbra/Indigo Systems (San Francisco, California). The objective of this clinical investigation is to evaluate, in a controlled setting, the early safety and effectiveness of the devices, and to define optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions.
This study will be an interventional prospective trial of patients with a diagnosis of ALLI, treated with Penumbra/Indigo devices. This project is intended to be a National platform where every Physician invited to participate could register his own data procedure. The primary outcome is the technical success of the thromboaspiration with the Indigo system. Assessment of vessel patency will be recorded using the Thrombolysis in Myocardial Infarction (TIMI) score classifications both before and after use of the device. Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-month follow-up of one class or more as compared to the pre-procedure Rutherford classification. Secondary Endpoints include: safety rate at discharge, defined as absence of any serious adverse events (SAE); primary patency at 1 month, defined as a target lesion without a hemodynamically significant stenosis/reocclusion on duplex ultrasound (>50%,) and without target lesion reintervention (TLR) within 1 month; Limb salvage at 1 month.
The study is currently in the recruitment phase, and the final patient is expected by the end of March 2019. 150 patients will be recruited. Analyses will focus on primary and secondary endpoints.
The analysis of primary and secondary endpoints is expected by the end of 2019. These new endovascular thrombectomy devices specifically designed for peripheral intervention in this difficult set of patients, as that under investigation in the proposed registry, may offer improved clinical outcomes with lower rates of major systemic and local complications. After completion of the present study, it is expected that the value of the Indigo thrombectomy system in the treatment of ALLI will be better defined. As a result, a shift of treatment recommendation towards endovascular options may be observed in the near future. Clinical Trial: Clinicaltrials.gov Identifier: NCT03386370
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