Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT01407159
Eligibility Criteria:
The clinical records of the patients mus support the following criteria:
* Age \> 18 years
* Type B dissection with expanding false lumen eligible for endovascular treatment which occured within 90 days prior to implantation
* The endovascular treatment may be associated with a complementary surgical operation
* The total diameter of the dissected aortic segment should not surpass 6cm, and have increased between 0.5 and 1cm within 1 month, prior to implantation
* Visceral arteries involvement, i.e. perfusion of side branches via true or false lumen of type B dissection
* Aortic kinking \< 90°
* The patient must be available for the appropriate follow-up times for the duration of the study
* Informed consent from patient or authorized relative
The data of whose patients clinical records confirm one of the following conditions will not be considered in this study:
* Patients with a contraindication as indicated in the instruction for use
* Patients with chronic thrombocytopenia or ongoing anticoagulation
* Patients with renal failure and/or creatinine \>2.4mg/dl immediately before the intervention
* Patients in whom the false lumen is completely thrombosed
* Patients with ongoing infection
* Patients with ongoing cancer
* Patients who are enrolled in a clinical study
* Aortic landing zone diameter over 40 mm
* Potentially emboligenic iliac and aortic atheroma lesions
* Associated pathology with life expectancy of less than 24 months
* Unstable infectious syndrome
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01407159
Study Brief:
Protocol Section:
NCT01407159