Status:
TERMINATED
A Study in Patients with a Descending TAA or PAU Treated with the E-nya Thoracic Stent Graft System
Lead Sponsor:
JOTEC GmbH
Collaborating Sponsors:
MedPass International
Conditions:
Vascular Aneurysm
Eligibility:
All Genders
18-85 years
Brief Summary
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 Sys...
Detailed Description
In this study, patients who receive an E-nya Thoracic Stent Graft for the endovascular treatment of descending thoracic aortic aneurysm or PAU will be observed. The E-nya Thoracic Stent Graft will be ...
Eligibility Criteria
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
- 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 Ehler-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
- Mycotic aneurysm
- 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
- 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)
- 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
Key Trial Info
Start Date :
June 12 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 24 2024
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04381507
Start Date
June 12 2020
End Date
July 24 2024
Last Update
October 18 2024
Active Locations (1)
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1
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany, 48149