A Study in Patients With Complicated Type B Aortic Dissection Treated With the E-nya Thoracic Stent Graft (CONFORM-TAD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Diseases
• Intervention / Treatment: Device: endovascular repair

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.

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Münster, NRW, Germany, 48149
      • Recruiting
      • Universitatsklinikum Munster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Rate of all-cause mortality	30-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Rate of all-cause mortality	12, 24, 36, 60 months
Technical success	Technical success is achieved in case all above mentioned criteria are fulfilled however, a reintervention was performed.	24 hours
Clinical success	Clinical success is achieved in case all above mentioned criteria are fulfilled however, a reintervention was performed.	prior to discharge/30-day, 12, 24, 36, and 60 months
Cerebrovascular event	Rate of patients with new cerebrovascular event/stroke (excluding transient ischemic attack)	30-day, 12, 24, 36, and 60 months
Dislodgement	Rate of patients with E-nya Stent Graft dislodgement (full component separation)	prior to discharge/30-day, 12, 24, 36, and 60 months
Integrity	Rate of patients with failure of E-nya Stent Graft integrity (stent fracture, fabric erosion)	prior to discharge/30-day, 12, 24, 36, and 60 months
Infolding	Rate of patients with infolding of an E-nya Stent Graft	prior to discharge/30-day, 12, 24, 36, and 60 months
Mortality	Rate of all-cause mortality	24 hours
Dissection related mortality	Rate of dissection related mortality	30-day, 12, 24, 36, 60 months
Primary technical success	Primary technical success related to the E-nya Thoracic Stent Graft System combines the following criteria: It is related to periprocedural events that occur from the initiation of the procedure and extend through the first 24-hours postoperative period; Defined on an intent-to-treat basis; Successful access to the arterial system using a remote site (ie, the femoral, external iliac, common iliac, abdominal aorta, or brachiocephalic arteries with or without use of a temporary or permanent prosthetic conduit to access these arteries); Successful deployment of the endoluminal graft at the intended location; Coverage of the primary entry tear; Absence of reintervention, surgical conversion to open repair or death ≤24 h; Patent endoluminal graft	24 hours
Primary clinical success	Primary clinical success related to the E-nya Thoracic Stent Graft combines the following criteria: Clinical success should be reported on an intent-to-treat basis; Initially required successful deployment of the E-nya Thoracic Stent Graft at the intended location without anyDeath as a result of the pathology that was treatedConversion to open repairReinterventionE-nya Thoracic Stent Graft infectionE-nya Thoracic Stent Graft infoldingCausing a new thoracic aortic pathology as a result of the intervention (e.g. pseudoaneurysm, dissection, intramural hematoma)	prior to discharge/30-day, 12, 24, 36, and 60 months
Major Adverse Events (MAE)	• Rate of patients with major adverse event(s) (death, aneurysm rupture , conversion to open surgical repair, retrograde type A dissection, stent graft induced new entry tear requiring intervention, new myocardial infarction requiring intervention (percutaneous transluminal coronary angioplasty, bypass), new disabling stroke, new permanent paraplegia, new permanent paraparesis, new chronic renal insufficiency/renal failure requiring dialysis, bowel resection, > 72 hours artificial respiratory assistance, device induced trauma requiring intervention) product-related, procedure-related, dissection-related)	30-day, 12, 24, 36, 60 months
Conversion to open surgical repair	Rate of patients with conversion to open surgical repair	24 hours, 30-day, 12, 24, 36, 60 months
Size of true lumen	Rate of patients with increasing (>5 mm) or stable true lumen in the stented region	prior to discharge/30-day, 12, 24, 36, and 60 months
Size of false lumen	Rate of patients with stable or decreasing (<5 mm) false lumen in the stented region	prior to discharge/30-day, 12, 24, 36, and 60 months
Status of false lumen	Rate of patients with obliterated, completely thrombosed, partially thrombosed, or patent false lumen in the stented region (top, middle, 2 cm proximal to distal end), between the bottom of the stent and the celiac trunk, and between the celiac trunk and the aortic bifurcation	prior to discharge/30-day, 12, 24, 36, and 60 months
Primary entry tear	Rate of patients with covered primary entry tear	prior to discharge/30-day, 12, 24, 36, and 60 months
Secondary intervention(s)	Rate of patients with secondary intervention(s)	30-day, 12, 24, 36, and 60 months
Reintervention(s)	Rate of patients with reintervention(s)	30-day, 12, 24, 36, and 60 months
Permanent paraplegia	Rate of patients with a new permanent paraplegia	30-day, 12, 24, 36, and 60 months
Permanent paraparesis	Rate of patients with a new permanent paraparesis	30-day, 12, 24, 36, and 60 months
Migration	Rate of E-nya stent graft migration; Rate of patients with proximal E-nya Thoracic Stent Graft migration >5 mm; Rate of patients with distal E-nya Thoracic Stent Graft migration >5 mm	prior to discharge/30-day, 12, 24, 36, and 60 months

Collaborators and Investigators

• Sponsor: JOTEC GmbH
• Collaborators: MedPass International

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 25, 2020
• Primary Completion (ANTICIPATED): March 30, 2024
• Study Completion (ANTICIPATED): May 31, 2030

Study Registration Dates

• First Submitted: May 3, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (ACTUAL): May 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Aorta; Dissection; Descending; Complicated
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Aneurysm; Vascular Diseases; Aneurysm, Dissecting
• Other Study ID Numbers: CONFORM-TAD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No