Vascular DiseasesCONFORM-TADNCT04378361
A Study in Patients With Complicated Type B Aortic Dissection Treated With the E-nya Thoracic Stent Graft
An observational study of Vascular Diseases, run by JOTEC GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- endovascular repair
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 25 May 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 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.
Who may be able to join
- 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
Show all 20Show fewer
- 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
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 Ehlers-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 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149
About this study
Official title: 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.
Read the 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.
- Conditions
- Vascular Diseases
- Being tested
- endovascular repair
- Keywords
- Descending, Aorta, Dissection, Complicated
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovascular repairDevice
Endovascular repair of complicated acute, subacute or chronic type B aortic dissection with double lumen
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Rate of all-cause mortality
Measured: 30-day
Secondary outcomes (22)
Mortality
Rate of all-cause mortality
Measured: 24 hours
Mortality
Rate of all-cause mortality
Measured: 12, 24, 36, 60 months
Dissection related mortality
Rate of dissection related mortality
Measured: 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
Measured: 24 hours
Technical success
Technical success is achieved in case all above mentioned criteria are fulfilled however, a reintervention was performed.
Measured: 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 any
- Death as a result of the pathology that was treated
- 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 (e.g. pseudoaneurysm, dissection, intramural hematoma)
Measured: 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.
Measured: 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)
Measured: 30-day, 12, 24, 36, 60 months
Conversion to open surgical repair
Rate of patients with conversion to open surgical repair
Measured: 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
Measured: 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
Measured: 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
Measured: prior to discharge/30-day, 12, 24, 36, and 60 months
Primary entry tear
Rate of patients with covered primary entry tear
Measured: prior to discharge/30-day, 12, 24, 36, and 60 months
Secondary intervention(s)
Rate of patients with secondary intervention(s)
Measured: 30-day, 12, 24, 36, and 60 months
Reintervention(s)
Rate of patients with reintervention(s)
Measured: 30-day, 12, 24, 36, and 60 months
Cerebrovascular event
Rate of patients with new cerebrovascular event/stroke (excluding transient ischemic attack)
Measured: 30-day, 12, 24, 36, and 60 months
Permanent paraplegia
Rate of patients with a new permanent paraplegia
Measured: 30-day, 12, 24, 36, and 60 months
Permanent paraparesis
Rate of patients with a new permanent paraparesis
Measured: 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
Measured: prior to discharge/30-day, 12, 24, 36, and 60 months
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
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
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.
- First posted7 May 2020
- Study start25 May 2020
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Why it stopped: Expiry of CE mark.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- JOTEC GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedPass International
- Responsible party
- Sponsor
- Investigators
- Jan Brunkwall, Prof., Study director, BrumedJost P. Schäfer, Prof., Study chair, University Hospital Schleswig-Holstein (UKSH) Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378361
- Sponsor's protocol ID
- CONFORM-TAD
- Acronym
- CONFORM-TAD
- Status last verified
- Jul 2024
- First submitted
- 3 May 2020
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04378361
- Acronym / sponsor ID
- CONFORM-TAD / CONFORM-TAD
- Conditions
- Vascular Diseases
- Keywords
- Descending, Aorta, Dissection, Complicated
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Expiry of CE mark.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- JOTEC GmbHIndustry (pharma, biotech, devices)
- Collaborators
- MedPass International
- Study start
- 25 May 2020 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (20 listed)
- Age between 18 and 85 years
- Complicated acute, subacute or chronic type B aortic dissection with evidence of at least one of the following:
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endovascular repairEndovascular repair of complicated acute, subacute or chronic type B aortic dissection with double lumen | Device | – |
Primary outcome
Mortality
Time frame: 30-day
Rate of all-cause mortality
22 secondary outcomes
Mortality
Time frame: 24 hours
Mortality
Time frame: 12, 24, 36, 60 months
Dissection related mortality
Time frame: 30-day, 12, 24, 36, 60 months
Primary technical success
Time frame: 24 hours
Technical success
Time frame: 24 hours
Primary clinical success
Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months
Clinical success
Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months
Major Adverse Events (MAE)
Time frame: 30-day, 12, 24, 36, 60 months
Conversion to open surgical repair
Time frame: 24 hours, 30-day, 12, 24, 36, 60 months
Size of true lumen
Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months
Size of false lumen
Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months
Status of false lumen
Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months
Primary entry tear
Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months
Secondary intervention(s)
Time frame: 30-day, 12, 24, 36, and 60 months
Reintervention(s)
Time frame: 30-day, 12, 24, 36, and 60 months
Cerebrovascular event
Time frame: 30-day, 12, 24, 36, and 60 months
Permanent paraplegia
Time frame: 30-day, 12, 24, 36, and 60 months
Permanent paraparesis
Time frame: 30-day, 12, 24, 36, and 60 months
Migration
Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months
Dislodgement
Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months
Integrity
Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months
Infolding
Time frame: prior to discharge/30-day, 12, 24, 36, and 60 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Brunkwall, Prof. study director
Brumed
Jost P. Schäfer, Prof. study chair
University Hospital Schleswig-Holstein (UKSH) Kiel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Diseases, 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 20 inclusion and 16 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: withdrawn, as of the sponsor's last update on 25 Jul 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 withdrawn before enrolling participants, so there are no results.
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?
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 25 Jul 2024.