Clinical Study to Evaluate the Safety, Efficacy and Cost Analysis of the GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System FOR Patients With Descending Thoracic Aortic Pathologies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- • Freedom from descending thoracic aorta-related mortality
研究概览
简要总结
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).
详细描述
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. The investigators 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Patient not willing to give consent for transmission of personal "pseudonymised" data
- •For females: pregnancy or lactation
- •Women of childbearing potential (not postmenopausal or surgically sterile) not willing to use an effective method of contraception during the study. Effective methods are hormonal contraceptives (e.g., oral, implanted, or injected), intrauterine device (IUDs), and sexual abstinence.
- •Patient committed to an institution by virtue of an order issued either by the courts or by an authority
- •Patient who is unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study.
结局指标
主要结局
• Freedom from descending thoracic aorta-related mortality
时间窗: 0-3 years
Mortality rate related to the descending thoracic aorta condition or its endovascular repair or procedure
• Delivery and deployment success evaluation
时间窗: during the index procedure
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
次要结局
- 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)
研究者
V. Riambau, MD, PhD
Professor and chief of vascular surgery division
Endovascular Foundation