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

NCT04452240 | Unknown DMC

• 1 other identifier: EVF01
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 3

Brief 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

Keywords

thoracic endograft; direct cost; safety; efficacy

Outcome Measures

Primary Outcomes (2)

• • Freedom from descending thoracic aorta-related mortality

  Mortality rate related to the descending thoracic aorta condition or its endovascular repair or procedure

  0-3 years

• • Delivery and deployment success evaluation

  it includes the following qualitative variables: * Delivery system evaluation * Overall rate of vascular access complications (≤30 days) * Rate of access failures * Rate of deployment system difficulties or failures * Rate of angulation tool usage * Rate of arterial pressure reduction maneuver

  during the index procedure

Secondary Outcomes (2)

• o Micro-costing analysis

  0-3 years

• o Change in Health-Related Quality of Life (HRQoL) as assessed using the EuroQoL Group EQ-5D (EQ-5D-5L)

  0-3 years

Interventions

thoracic endovascular repair DEVICE

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

Also known as: TEVAR

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Elective and Urgent Thoracic aorta pathologies such as TAAs, pseudoaneurysms, TBADs, BTAIs, PAUs and IMHs, are eligible for screening for participation in the study. Only patients who meet all of the Inclusion Criteria and none of the Exclusion Criteria will be enrolled

You may qualify if:

• Male / female
• Age between 18 and 90 years of age
• Patient diagnosed with thoracic aorta pathology (TAA, TBAD, BTAI, PAU, IMH) suitable for TEVAR with a C-TAG Active Control stent-graft; diagnosis must be confirmed by contrast computed tomography angiography (CTA) or magnetic resonance imaging (MRI) within 3 months of the planned implant procedure.
• Proximal and distal aortic necks suitable for stent-graft placement (i.e., inner diameter ranging between 16 and 42 mm)
• Proximal and distal landing zones suitable for the stent-graft
• Adequate vascular access for insertion of the delivery system
• Written informed consent upon enrolment

You may not qualify if:

• Aneurysm/lesion location not accessible to the delivery system and stent placement
• Arterial access size insufficient for delivery system entrance or impossibility to perform a surgical access conduit
• Treatment of lesion that would require a delivery system with usable length greater than 90 cm
• Excessive arterial disease precluding delivery system entrance or passage
• Systemic infection
• Arterial tortuosity not allowing passage of the delivery system
• Arterial or aneurysm/lesion size incompatible with stent graft
• Mycotic aneurysm/lesions
• Massive thrombus
• Bleeding diathesis
• Any condition (medical or anatomic) which makes the patient not suitable for endovascular repair according to the opinion of the investigator
• Untreatable allergy or history of allergic reaction to radiographic contrast medium
• Untreatable allergy or history of allergic reaction to anticoagulants
• Hypersensitivity to any of the components of the C-TAG device
• Participation in an investigational clinical study involving a new chemical entity or medical device within 3 months or 1 year, respectively, prior to the planned procedure

Sponsors & Collaborators

• Endovascular Foundation: lead
• W.L.Gore & Associates: collaborator
• Bocconi University: collaborator

Study Sites (3)

Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

RECRUITING

Spedali Civili di Brescia

Brescia, Italy

RECRUITING

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Vincent RIAMBAU, MD. PhD

  Endovascular Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

vincent RIAMBAU, MD,PhD

CONTACT

+34607958090; vriambau@gmail.com

Santi Trimarchi, MD. PhD

CONTACT

satrimarchi@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and chief of vascular surgery division

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 30, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2024
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); ES (1)