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

NCT04378361 | Withdrawn

• 1 other identifier: CONFORM-TAD
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Diseases

Keywords

Descending; Aorta; Dissection; Complicated

Outcome Measures

Primary Outcomes (1)

• Mortality

  Rate of all-cause mortality

  30-day

Secondary Outcomes (22)

• Mortality

  24 hours

• Mortality

  12, 24, 36, 60 months

• Dissection related mortality

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

• Primary technical success

  24 hours

• Technical success

  24 hours

Interventions

endovascular repair DEVICE

Endovascular repair of complicated acute, subacute or chronic type B aortic dissection with double lumen

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 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.

You may qualify if:

• 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

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 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
• 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

Sponsors & Collaborators

• JOTEC GmbH: lead
• MedPass International: collaborator

Study Sites (1)

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

MeSH Terms

Conditions

Vascular Diseases

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

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 3, 2020
• First Posted: May 7, 2020
• Study Start: May 25, 2020
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

DE (1)