A Study in Patients with a Descending TAA or PAU Treated with the E-nya Thoracic Stent Graft System (CONFORM-TAA)

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

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.

Study Overview

• Status: Terminated
• Conditions: Vascular Aneurysm
• Intervention / Treatment: Device: endovascular repair

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.

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Münster, NRW, Germany, 48149
      • Universitätsklinikum Münster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

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 during the peri-operative period	24 hours
Mortality	Rate of all-cause mortality	12, 24, 36, 60 months
Mortality	Rate of aneurysm / PAU related mortality	30-day, 12, 24, 36, 60 months
Rupture	Rate of patients with aneurysm / PAU rupture	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; Absence of reintervention, surgical conversion to open repair or death ≤24 h	24 hours
Technical success	Technical success is achieved in case all above mentioned criteria are fulfilled however, a reintervention was performed.	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 treatedRupture of descending thoracic aortic aneurysm or PAUConversion to open repairReinterventionE-nya Thoracic Stent Graft infectionE-nya Thoracic Stent Graft infoldingCausing a new thoracic aortic pathology as a result of the intervention (eg, pseudoaneurysm, dissection, intramural hematoma, fistula)	prior to discharge/30-day, 12, 24, 36, and 60 months
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
Major adverse event(s)	Rate of patients with major adverse event(s) (death, aneurysm rupture, conversion to open surgical repair, retrograde type A dissection, stent graft induced postimplantation dissection 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, aneurysm related)	30-day, 12, 24, 36, and 60 months
Conversion to open surgery	Rate of patients with conversion to open surgical repair	24hours, 30-day, 12, 24, 36, and 60 months
Reintervention	Rate of patients with reintervention(s)	30-day, 12, 24, 36, and 60 months
Aneurysm size	Rate of patients with decreasing (<5 mm), stable, increasing (>5 mm) aneurysm size	12, 24, 36, and 60 months
Endoleak Type Ia	Rate of patients with type Ia endoleak	prior to discharge/30-day, 12, 24, 36, and 60 months
Endoleak Type Ib	Rate of patients with type Ib endoleak	prior to discharge/30-day, 12, 24, 36, and 60 months
Endoleak Type II	Rate of patients with type II endoleak	prior to discharge/30-day, 12, 24, 36, and 60 months
Endoleak Type III	Rate of patients with type III endoleak	prior to discharge/30-day, 12, 24, 36, and 60 months
Endoleak Type IV	Rate of patients with type IV endoleak	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
Permanent paraplegia	Rate of patients with new new permanent paraplegia	30-day, 12, 24, 36, and 60 months
Permanent paraparesis	Rate of patients with new 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 Stent Graft migration (>5 mm); Rate of patients with distal E-nya Stent Graft migration (>5 mm)	prior to discharge/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

Collaborators and Investigators

• Sponsor: JOTEC GmbH
• Collaborators: MedPass International
• Investigators: Study Director: Jan Brunkwall, Prof., Brumed; Study Chair: Jost P. Schäfer, Prof., University Hospital Schleswig-Holstein (UKSH) Kiel

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Actual): July 24, 2024
• Study Completion (Actual): July 24, 2024

Study Registration Dates

• First Submitted: May 2, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Aorta; Ulcer; Descending; Penetrating
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm
• Other Study ID Numbers: CONFORM-TAA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No