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 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT04378361
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 85 years
* Complicated acute, subacute or chronic type B aortic dissection with evidence of at least one of the following:
* Malperfusion (visceral, renal, spinal cord and/or lower limb ischemia)
* Three of the following risk factors in acute or subacute dissections
* Young patient
* Primary entry tear \> 10 mm
* Early aortic expansion \> 5 mm within 6 months
* Total aortic diameter \> 40 mm
* False lumen diameter \> 20 mm
* Partially thrombosed false lumen
* Total diameter \> 50 mm in case of chronic dissections
* Patient is hemodynamically stable (stable blood pressure and heart rate, no shock)
* Planned proximal and distal landing zone of the E-nya Thoracic Stent Graft component(s) in the native aorta
* Landing zone of the proximal edge of the fabric distal to the left carotid artery
* Landing zone of the distal edge of the fabric proximal to the celiac trunk
* Proximal landing zone diameter between 20 and 44 mm
* Centerline distance from the distal edge of the left carotid artery to the start of the most proximal tear ≥ 20 mm
* Thoracic aortic lesion confirmed by thin sliced (≤ 1 mm) CTA with optional three-dimensional reconstruction obtained within 3 months prior to the implant procedure
* Patient is able and willing to undergo follow-up imaging and examinations prior to discharge from the hospital, at 30 days and 12 months, and annually thereafter until 5 years follow-up
* Patient understands and has signed the Informed Consent Form prior to intervention whenever possible or after the intervention in case the patient's status does not allow consent to be obtained prior to intervention
Exclusion Criteria:
* Female of child bearing potential, breast feeding
* Access vessels not suitable for endovascular treatment
* Significant circular thrombi or calcification in proximal or distal landing zones
* Genetic connective tissue diseases (e.g. Marfan Syndrome or Ehlers-Danlos Syndrome)
* Allergies against materials necessary for endovascular repair (e.g. contrast media, heparin, materials of the stent graft)
* Systemic or local infections
* eGFR \< 45 ml/min/1.73m2 before the intervention
* Myocardial infarction or cerebrovascular accident \< 3 months
* Patient has specified disease of the thoracic aorta which is not included in the registry, for example: intramural hematoma, penetrating aortic ulcer, traumatic injury or transection, (contained) aortic rupture (hemorrhage outside of aorta)
* Patients who are planned to be treated with a chimney in the left subclavian artery
* Patients who are planned to be treated with the Petticoat concept
* Previous stent and/or stent graft or previous surgical repair of descending thoracic aorta
* Patient had or planned to have a major surgical or interventional procedure within 30 days before or 30 days after the planned implantation of the E-nya Stent Graft System(s). This exclusion does not include planned procedures that are needed for the safe and effective placement of the stent graft (ie, carotid/subclavian transposition, carotid/subclavian bypass procedure)
* Other medical condition that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with a limited life expectancy (i.e. heart failure, active malignancy (progressive, stable or partial remission))
* Simultaneously participating in another clinical trial
* NYHA class IV
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04378361
Study Brief:
Protocol Section:
NCT04378361