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Safety, Efficacy and Cost Analysis of the Conformable Thoracic Stent Graft With ACTIVE CONTROL

NCT04452240 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2021-09-21

No results posted yet for this study

Summary

Study Design This is a prospective, multicenter, non-randomized clinical study in patients presenting thoracic aortic pathologies.

Following a baseline assessment, the implantation procedure will be performed according to the Instructions for Use and local routine practice. A follow-up visit will be performed 30 days, 6, 12,24 and 36 months after the implantation procedure.

The investigator will perform assessments of the implantation procedure and device system and document adverse events (AE) and device deficiencies. Resources utilization and unit costs will be collected at index procedure and during follow-up. HRQoL is going to be investigated in this prospective study using the generic questionnaire EQ5D 5 levels, comparing pre- and postoperative scores.

Study Objective The objective of the study is to evaluate the safety, performance and resource utilization associated with the use of GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL systems in humans having thoracic aortic pathologies. Safety will be evaluated considering mortality and morbidity variables (mainly focused on device related complications). Efficacy will be evaluated according to the variables related to the technical and clinical successes. In addition, resource utilization and associated costs will be collected prospectively with the objective to analyze differences in resource utilization between outcome groups, landing zone groups, disease severity groups, adverse event groups and case-mix groups. We will calculate the average marginal costs increase for complications when they occurred during TEVAR or surgical revascularization (e.g., paralysis, stroke, nerve injury, lymph damages, myocardial infarction, major bleeding event, respiratory complication). Resource utilization analysis is not going to be limited to the index procedure but will continue during follow-up.

Subject Population: Elective and Urgent Thoracic aorta pathologies such as aneurysms, pseudoaneurysms, dissections, blunt thoracic aorta injury, penetrating ulcers and intramural hematoma.

Planned number of patients: A total of 200 patients. Approx. 20 study centers in 2 European countries (15 in Italy and 5 in Spain) . A subgroup of 8centers will be selected for the micro-costing analysis (7 in Italy and one in Barcelona) Expected Time to Complete Enrollment: end of 2021 (18 months).

Conditions

  • Thoracic Aorta
  • Thoracic Aorta Aneurysm
  • Thoracic Aorta Abnormality

Interventions

DEVICE

thoracic endovascular repair

Repair of thoracic aorta lesions with the application of a dedicatet stent-graft by endovascular way.

Sponsors & Collaborators

  • W.L.Gore & Associates

    collaborator INDUSTRY

  • Bocconi University

    collaborator OTHER

  • Endovascular Foundation

    lead OTHER

Principal Investigators

  • Vincent RIAMBAU, MD. PhD · Endovascular Foundation

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2023-07-01
Completion
2024-12-01

Countries

  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04452240 on ClinicalTrials.gov