Clinical trial NCT04381507: A Study in Patients with a Descending TAA or PAU Treated with the E-nya Thoracic Stent Graft System
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Vascular Aneurysm
Keywords: Descending
Aorta
Penetrating
Ulcer
Lead sponsor: JOTEC GmbH
Sponsor class: INDUSTRY
Collaborators: name: MedPass International
First posted: 2020-05-11
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female patients with descending thoracic aortic aneurysm or PAU and who are eligible for treatment with a thoracic stent graft according to the instructions for use for the E-nya Thoracic Stent Graft System and scheduled for implantation of the E-nya Thoracic Stent Graft System at their physician's discretion in accordance with the listed inclusion / exclusion criteria.

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 System. The secondary objective is to evaluate the safety and clinical performance of the device.

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 implanted in accordance with the instructions for use of the E-nya Thoracic Stent Graft System and at the discretion of the treating physician.

Participating physicians will be asked to provide their observations collected during routine standard of care for patients he/she had decided to treat with the E-nya Thoracic Stent Graft System. Informed consent of the patients will be obtained to allow the use of their clinical records for the purpose of this observational study before data are being collected.

The period of data collection for each patient will be approximately 60 months from the intervention. Source document verification will be performed on 100% of patients; data from all visits will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans will be sent to the CoreLab for independent evaluation.

Eligibility criteria: Inclusion Criteria:

* 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 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 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

Primary outcomes:
measure: Mortality
timeFrame: 30-day
Secondary outcomes:
measure: Mortality
timeFrame: 24 hours
measure: Mortality
timeFrame: 12, 24, 36, 60 months
measure: Mortality
timeFrame: 30-day, 12, 24, 36, 60 months
measure: Rupture
timeFrame: 30-day, 12, 24, 36, 60 months
measure: Primary technical success
timeFrame: 24 hours
measure: Technical success
timeFrame: 24 hours
measure: Primary clinical success
timeFrame: prior to discharge/30-day, 12, 24, 36, and 60 months
measure: Clinical success
timeFrame: prior to discharge/30-day, 12, 24, 36, and 60 months
measure: Major adverse event(s)
timeFrame: 30-day, 12, 24, 36, and 60 months
measure: Conversion to open surgery
timeFrame: 24hours, 30-day, 12, 24, 36, and 60 months
measure: Reintervention
timeFrame: 30-day, 12, 24, 36, and 60 months
measure: Aneurysm size
timeFrame: 12, 24, 36, and 60 months
measure: Endoleak Type Ia
timeFrame: prior to discharge/30-day, 12, 24, 36, and 60 months
measure: Endoleak Type Ib
timeFrame: prior to discharge/30-day, 12, 24, 36, and 60 months
measure: Endoleak Type II
timeFrame: prior to discharge/30-day, 12, 24, 36, and 60 months
measure: Endoleak Type III
timeFrame: prior to discharge/30-day, 12, 24, 36, and 60 months
measure: Endoleak Type IV
timeFrame: prior to discharge/30-day, 12, 24, 36, and 60 months
measure: Cerebrovascular event
timeFrame: 30-day, 12, 24, 36, and 60 months
measure: Permanent paraplegia
timeFrame: 30-day, 12, 24, 36, and 60 months
measure: Permanent paraparesis
timeFrame: 30-day, 12, 24, 36, and 60 months
measure: Migration
timeFrame: prior to discharge/30-day, 12, 24, 36, and 60 months
measure: Dislodgement
timeFrame: prior to discharge/30-day, 12, 24, 36, and 60 months
measure: Integrity
timeFrame: prior to discharge/30-day, 12, 24, 36, and 60 months
measure: Infolding
timeFrame: prior to discharge/30-day, 12, 24, 36, and 60 months
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: NRW
Study officials:
affiliation: Brumed
name: Jan Brunkwall, Prof.
role: STUDY_DIRECTOR
affiliation: University Hospital Schleswig-Holstein (UKSH) Kiel
name: Jost P. Schäfer, Prof.
role: STUDY_CHAIR
References: