Thrombectomy In ANdalucia Using Aspiration (TRIANA)

Status Completed

Clinical Trial Summary

This study aims to compare the efficacy and safety of ADAPT vs Stentriever techique in a multicenter stroke cohort of patients.

Clinical Trial Description

In Andalusia, current data show that the mortality rate from stroke is 50% higher than in Spain as a whole. Endovascular therapy has revolutionized the treatment of acute stroke and could improve these high mortality rates. The investigators propose to take the great advance that the thrombectomy has given to the community of Andalusia in which there are more limited resources with several strategies such as the implementation of strict protocols of inclusion through a common registry, use of cheaper equipment (aspiration vs stent-retrievers)

The objective of the TRIANA trial is thus to:

1. Demonstrate that the use of thrombectomy systems with direct aspiration first pass technique (ADAPT ) using the new large-bore 6F SOFIA Plus catheter (MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation) is equal in safety and efficacy to the results of thrombectomy with stent retriever.

2) The use of mechanical aspiration systems would lead to a decrease in cost per procedure, shortening the duration of treatment and decrease the rate of embolism to new territory.

3) Identify futile recanalization blood biomarkers that will allow the investigators in the future to treat only those patients who will benefit from the most adequate reperfusion treatment.

The design is an observational, prospective and multicentric study of patients with acute ischemic stroke of anterior circulation and less than 8 hours of evolution treated with neurointerventionist rescue techniques to study safety, effectiveness, costs of the intervention and duration (puncture-recanalization) of the thrombectomy system with aspiration with Sofia Plus in comparison with the stent retrievers system.

1. To evaluate the safety and effectiveness of thrombectomy with manual mechanical aspiration with Sofia Plus under clinical practice conditions.

2. Determine if the duration (puncture-recanalization) of thrombectomy with aspiration is less than that of stents retrievers; And if the number of embolisms distal to new vascular territories decreases with aspiration.

3. To estimate the cost savings by procedure in the treatment of ischemic stroke and to analyze the efficiency (cost effectiveness) of thrombectomy with aspiration. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03407092
Study type	Observational [Patient Registry]
Source	Hospitales Universitarios Virgen del Rocío
Contact
Status	Completed
Phase
Start date	January 1, 2018
Completion date	December 31, 2018

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Thrombectomy In ANdalucia Using Aspiration (TRIANA) — TRIANA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms