Status:
WITHDRAWN
A Study in Patients With Complicated Type B Aortic Dissection Treated With the E-nya Thoracic Stent Graft
Lead Sponsor:
JOTEC GmbH
Collaborating Sponsors:
MedPass International
Conditions:
Vascular Diseases
Eligibility:
All Genders
18-85 years
Brief Summary
The CONFORM-TAD post-market clinical follow-up study is undertakento evaluate the prevention of death related to the treatment of a complicated acute, subacute or chronic type B aortic dissection with...
Detailed Description
In this study, patients who receive an E-nya Thoracic Stent Graft for the treatment of a complicated acute, subacute or chronic type B aortic dissection will be observed. The E-nya Thoracic Stent Graf...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 24 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04378361
Start Date
May 25 2020
End Date
July 24 2024
Last Update
July 25 2024
Active Locations (1)
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1
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany, 48149