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

NCT04381507 | Terminated

• 1 other identifier: CONFORM-TAA
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Aneurysm

Keywords

Descending; Aorta; Penetrating; Ulcer

Outcome Measures

Primary Outcomes (1)

• Mortality

  Rate of all-cause mortality

  30-day

Secondary Outcomes (24)

• Mortality

  24 hours

• Mortality

  12, 24, 36, 60 months

• Mortality

  30-day, 12, 24, 36, 60 months

• Rupture

  30-day, 12, 24, 36, 60 months

• Primary technical success

  24 hours

Interventions

endovascular repair DEVICE

Endovascular repair of descending thoracic aneurysms or PAU using a stent graft.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• JOTEC GmbH: lead
• MedPass International: collaborator

Study Sites (1)

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

MeSH Terms

Conditions

Ulcer

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Jan Brunkwall, Prof.

  Brumed

  STUDY DIRECTOR

• Jost P. Schäfer, Prof.

  University Hospital Schleswig-Holstein (UKSH) Kiel

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 11, 2020
• Study Start: June 12, 2020
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

DE (1)