A Study in Patients with a Descending TAA or PAU Treated with the E-nya Thoracic Stent Graft System
Reason given: Expiry of CE mark.
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Trial details
- Who runs it
- JOTEC GmbH
- Trial code
- NCT04381507
- Record updated
- 18 October 2024
- Original description
The CONFORM-TAA post-market clinical follow-up study is undertaken to evaluate the prevention of death related to a descending aortic aneurysm or PAU when treated by the E-nya Thoracic Stent Graft System. The secondary objective is to evaluate the safety and clinical performance of the device.Read full original descriptionShow less
CONFORM-TAA - a Post-market Clinical Follow-up Study in Patients with a Descending Thoracic Aortic Aneurysm or Penetrating Aortic Ulcer (PAU) Treated with the E-nya Thoracic Stent Graft System
The CONFORM-TAA post-market clinical follow-up study is undertaken to evaluate the prevention of death related to a descending aortic aneurysm or PAU when treated by the E-nya Thoracic Stent Graft System. The secondary objective is to evaluate the safety and clinical performance of the device.
Inclusion: Age between 18 and 85 years; A fusiform focal TAA ≥ 55 mm for females, ≥ 60 mm for males, or ≥ 2 times the diameter of the non-aneurysmal thoracic aorta and/or focal saccular TAA or penetrating aortic ulcer (PAU); Suitable proximal and distal landing zone 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 and distal non-aneurysmal neck diameter between 18 and 42 mm; Proximal non-aneurysmal neck length ≥ 20 mm; Distal non-aneurysmal neck length ≥ 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.
Exclusion: Patients who are planned to be treated with a chimney in the left subclavian artery; Treatment of a thoracoabdominal or infrarenal aneurysm at the time of implant; 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); Genetic connective tissue diseases (e.g. Marfan syndrome or Ehler-Danlos Syndrome); Allergies against materials necessary for endovascular repair (e.g. contrast media, heparin, materials of the stent graft); Systemic or local infections; Myocardial infarction or cerebrovascular accident < 3 months ago; Patient has specified disease of the thoracic aorta which is not included in the registry, for example: aortic dissection, intramural hematoma, traumatic injury or transection, aortic false aneurysm, (contained) ruptured aneurysm; 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)); eGFR < 45 ml/min/1.73m2 before the intervention; 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; Mycotic aneurysm; Simultaneously participating in another clinical trial; NYHA class IV.