Clinical trial NCT04378361: A Study in Patients With Complicated Type B Aortic Dissection Treated With the E-nya Thoracic Stent Graft
Official title: CONFORM-TAD- A Post-market Clinical Follow-up Study in Patients With Complicated Acute, Subacute or Chronic Type B Aortic Dissection With Double Lumen Treated With the E-nya Thoracic Stent Graft System
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Vascular Diseases
Keywords: Descending
Aorta
Dissection
Complicated
Lead sponsor: JOTEC GmbH
Sponsor class: INDUSTRY
Collaborators: name: MedPass International
First posted: 2020-05-07
Enrollment: 0
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 complicated acute, subacute or chronic type B aortic dissection 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 Stent Graft System at their physician's discretion in accordance with the listed inclusion / exclusion criteria.

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 the E-nya Thoracic Stent Graft System. The secondary objective is to evaluate safety and clinical performance of the device.

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 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
* 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

Primary outcomes:
measure: Mortality
timeFrame: 30-day
Secondary outcomes:
measure: Mortality
timeFrame: 24 hours
measure: Mortality
timeFrame: 12, 24, 36, 60 months
measure: Dissection related mortality
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 Events (MAE)
timeFrame: 30-day, 12, 24, 36, 60 months
measure: Conversion to open surgical repair
timeFrame: 24 hours, 30-day, 12, 24, 36, 60 months
measure: Size of true lumen
timeFrame: prior to discharge/30-day, 12, 24, 36, and 60 months
measure: Size of false lumen
timeFrame: prior to discharge/30-day, 12, 24, 36, and 60 months
measure: Status of false lumen
timeFrame: prior to discharge/30-day, 12, 24, 36, and 60 months
measure: Primary entry tear
timeFrame: prior to discharge/30-day, 12, 24, 36, and 60 months
measure: Secondary intervention(s)
timeFrame: 30-day, 12, 24, 36, and 60 months
measure: Reintervention(s)
timeFrame: 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: