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Vascular AneurysmCONFORM-TAANCT04381507

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

An observational study of Vascular Aneurysm, run by JOTEC GmbH at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Vascular Aneurysm
What is being tested?
endovascular repair
Type of treatment
Medical device
How many people
1 participants
Where
1 siteGermany
Study dates
12 Jun 2020to 24 Jul 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
endovascular repair
Keywords
Descending, Aorta, Penetrating, Ulcer
Medical subject headings
Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endovascular repairDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Rate of all-cause mortality

    Measured: 30-day

Secondary outcomes (24)

  1. Mortality

    Rate of all-cause mortality during the peri-operative period

    Measured: 24 hours

  2. Mortality

    Rate of all-cause mortality

    Measured: 12, 24, 36, 60 months

  3. Mortality

    Rate of aneurysm / PAU related mortality

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

  4. Rupture

    Rate of patients with aneurysm / PAU rupture

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

  5. 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

    Measured: 24 hours

  6. Technical success

    Technical success is achieved in case all above mentioned criteria are fulfilled however, a reintervention was performed.

    Measured: 24 hours

  7. 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 any
    • Death as a result of the pathology that was treated
    • Rupture of descending thoracic aortic aneurysm or PAU
    • Conversion to open repair
    • Reintervention
    • E-nya Thoracic Stent Graft infection
    • E-nya Thoracic Stent Graft infolding
    • Causing a new thoracic aortic pathology as a result of the intervention (eg, pseudoaneurysm, dissection, intramural hematoma, fistula)

    Measured: prior to discharge/30-day, 12, 24, 36, and 60 months

  8. Clinical success

    Clinical success is achieved in case all above mentioned criteria are fulfilled however, a reintervention was performed.

    Measured: prior to discharge/30-day, 12, 24, 36, and 60 months

  9. 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)

    Measured: 30-day, 12, 24, 36, and 60 months

  10. Conversion to open surgery

    Rate of patients with conversion to open surgical repair

    Measured: 24hours, 30-day, 12, 24, 36, and 60 months

  11. Reintervention

    Rate of patients with reintervention(s)

    Measured: 30-day, 12, 24, 36, and 60 months

  12. Aneurysm size

    Rate of patients with decreasing (<5 mm), stable, increasing (>5 mm) aneurysm size

    Measured: 12, 24, 36, and 60 months

  13. Endoleak Type Ia

    Rate of patients with type Ia endoleak

    Measured: prior to discharge/30-day, 12, 24, 36, and 60 months

  14. Endoleak Type Ib

    Rate of patients with type Ib endoleak

    Measured: prior to discharge/30-day, 12, 24, 36, and 60 months

  15. Endoleak Type II

    Rate of patients with type II endoleak

    Measured: prior to discharge/30-day, 12, 24, 36, and 60 months

  16. Endoleak Type III

    Rate of patients with type III endoleak

    Measured: prior to discharge/30-day, 12, 24, 36, and 60 months

  17. Endoleak Type IV

    Rate of patients with type IV endoleak

    Measured: prior to discharge/30-day, 12, 24, 36, and 60 months

  18. Cerebrovascular event

    Rate of patients with new cerebrovascular event/stroke (excluding transient ischemic attack)

    Measured: 30-day, 12, 24, 36, and 60 months

  19. Permanent paraplegia

    Rate of patients with new new permanent paraplegia

    Measured: 30-day, 12, 24, 36, and 60 months

  20. Permanent paraparesis

    Rate of patients with new new permanent paraparesis

    Measured: 30-day, 12, 24, 36, and 60 months

  21. 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)

    Measured: prior to discharge/30-day, 12, 24, 36, and 60 months

  22. Dislodgement

    Rate of patients with E-nya Stent Graft dislodgement (full component separation)

    Measured: prior to discharge/30-day, 12, 24, 36, and 60 months

  23. Integrity

    Rate of patients with failure of E-nya Stent Graft integrity (stent fracture, fabric erosion)

    Measured: prior to discharge/30-day, 12, 24, 36, and 60 months

  24. Infolding

    Rate of patients with infolding of an E-nya Stent Graft

    Measured: prior to discharge/30-day, 12, 24, 36, and 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2020
  2. Study start12 Jun 2020
  3. Primary completion24 Jul 2024
  4. Study completion24 Jul 2024

Why it stopped: Expiry of CE mark.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04381507
Sponsor's protocol ID
CONFORM-TAA
Acronym
CONFORM-TAA
Status last verified
Oct 2024
First submitted
2 May 2020
Last updated
18 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Vascular Aneurysm, run by JOTEC GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Expiry of CE mark.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 30-day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04381507.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.

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