Thoracoabdominal AneurysmCONNECTNCT03295682
Registry in Patients With Thoracoabdominal Aneurysms
An observational study of Thoracoabdominal Aneurysm, run by JOTEC GmbH at 1 site in Germany.
Trial summary
In this study patients will be observed, who receive a multi-branch stent graft tailored to the patients anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm Crawford type I, II, III, IV or V. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoabdominal Aneurysm
- What is being tested?
- Endovascular thoracoabdominal aneurysm repair
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- 1 siteGermany
- Study dates
- 11 Sep 2017to 30 Aug 2024
- How long will I take part?
- 36 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total number of 40 male and female patients with asymptomatic thoracoabdominal aortic aneurysm, treated with a multi-branch stent graft system.
Who may be able to join
- Age ≥ 18 years
- Patients must have a thoracoabdominal aneurysm type Crawford type I, II, III, IV, or V
- Patients must have a suitable proximal landing area
- Patients must have a suitable distal landing area in the abdominal aorta or the iliac arteries
- Patients must have suitable access vessels
- Patients must be available for the appropriate follow-up times for the duration of the study
- Patients have signed the informed consent before intervention
Who cannot join
- Patients with infectious aneurysm
- Patients with inflammatory aneurysm
- Patients with ruptured or symptomatic aneurysm
- Patients with traumatic aneurysm
- Patients with aortic dissection
- Patients who have a congenital degenerative collagen disease or connective tissue disorder
Show all 14Show fewer
- Patients with thrombocytopenia
- Patients with an eGFR < 45ml/min/1.73m2 before the intervention
- Patients with untreated hyperthyroidism
- Patients with malignancy needing chemotherapy or radiation
- Patients that will be treated or are treated with iliac branch devices
- Patients pre-treated with Nellix (Endologix) or Ovation (Endologix) or Altura (Lombard Medical) stent grafts
- Patients who are enrolled in another clinical study
- Patients with life expectancy of less than 36 months
Trial locations and contacts
1 site in 1 country.
Germany1 site
Uniklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Registry in Patients With Thoracoabdominal Aneurysms Treated With Multi-branch Stent Grafts Tailored to Their Individual Anatomies
In this study patients will be observed, who receive a multi-branch stent graft tailored to the patients anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm Crawford type I, II, III, IV or V.
The objective of this study is to evaluate clinical and technical success as well as safety and feasibility of the multi-branch stent graft Systems used in endovascular treatment of thoracoabdominal aortic aneurysms that cannot be treated with commercially available devices. Primary endpoint of this study is the rate of patients with stable or decreasing aneurysm size at 12 months follow-up.
Read the detailed description
In this study patients will be observed, who receive a multi-branch stent graft tailored to the patient´s anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm Crawford type I, II, III, IV or V. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with a multi-branch stent graft produced by JOTEC GmbH. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected.
The period of data collection will be 36 months from the intervention for each patient. A risk based source data verification will be performed. CT angiograms will be evaluated by a CoreLab.
- Conditions
- Thoracoabdominal Aneurysm
- Being tested
- Endovascular thoracoabdominal aneurysm repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular thoracoabdominal aneurysm repairDevice
Endovascular treatment of patients with thoracoabdominal aneurysm using a multibranch stent graft tailored to the patient´s anatomy in combination with peripheral covered stents to bridge the visceral arteries
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with stable or decreasing aneurysm size at 12 months follow-up (measured by CoreLab)
Decreasing size: >/= 5mm Increasing size: </= 5mm compared to first post-operative CT angiogram
Measured: 12 months follow-up
Secondary outcomes (13)
Rate of all cause mortality
Measured: intra-op, post-op until 36 months follow-up
Rate of patients with aneurysm rupture
Measured: post-op until 36 months follow-up
Rate of patients with main adverse events (product-related, procedure-related, aneurysm-related)
Measured: post-op until 36 months follow-up
Rate of interventions in peri-operative periods (all related interventions until index procedure)
Measured: intra-op
Rate of reinterventions
Measured: post-op until 36 months follow-up
Rate of patients with endoleaks type Ia, Ib, II, III, IV, V and of unknown origin
Measured: post-op until 36 months follow-up
Rate of patients with multi-branch stent graft migration
Measured: post-op until 36 months follow-up
Rate of patients with loss of device integrity
Measured: post-op until 36 months follow-up
Rate of patients with primary / secondary patency of branch vessels
Measured: post-op until 36 months follow-up
Rate of patients with stent graft infection
Measured: post-op until 36 months follow-up
Rate of patients with primary / secondary technical success
Measured: post-op until 36 months follow-up
Rate of patients with primary / secondary clinical success
Measured: post-op until 36 months follow-up
Rate of patients with removal or failure to implant the multi-branch stent graft
Measured: intra-op, post-op until 36 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start11 Sep 2017
- Primary completion31 May 2022
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoabdominal AneurysmStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- JOTEC GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hubert Schelzig, Professor, Study director, Uniklinikum Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295682
- Sponsor's protocol ID
- CONNECT
- Acronym
- CONNECT
- Status last verified
- Feb 2026
- First submitted
- 25 Sep 2017
- Last updated
- 17 Feb 2026
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry in Patients With Thoracoabdominal Aneurysms Treated With Multi-branch Stent Grafts Tailored to Their Individual Anatomies
- ClinicalTrials.gov ID
- NCT03295682
- Acronym / sponsor ID
- CONNECT / CONNECT
- Conditions
- Thoracoabdominal Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- JOTEC GmbHIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 28 Sep 2017 (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.
In this study patients will be observed, who receive a multi-branch stent graft tailored to the patients anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm Crawford type I, II, III, IV or V.
The objective of this study is to evaluate clinical and technical success as well as safety and feasibility of the multi-branch stent graft Systems used in endovascular treatment of thoracoabdominal aortic aneurysms that cannot be treated with commercially available devices. Primary endpoint of this study is the rate of patients with stable or decreasing aneurysm size at 12 months follow-up.
Detailed description
In this study patients will be observed, who receive a multi-branch stent graft tailored to the patient´s anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm Crawford type I, II, III, IV or V. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with a multi-branch stent graft produced by JOTEC GmbH. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected.
The period of data collection will be 36 months from the intervention for each patient. A risk based source data verification will be performed. CT angiograms will be evaluated by a CoreLab.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 36 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total number of 40 male and female patients with asymptomatic thoracoabdominal aortic aneurysm, treated with a multi-branch stent graft system.
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Patients must have a thoracoabdominal aneurysm type Crawford type I, II, III, IV, or V
- Patients must have a suitable proximal landing area
- Patients must have a suitable distal landing area in the abdominal aorta or the iliac arteries
- Patients must have suitable access vessels
Key exclusion criteria (14 listed)
- Patients with infectious aneurysm
- Patients with inflammatory aneurysm
- Patients with ruptured or symptomatic aneurysm
- Patients with traumatic aneurysm
- Patients with aortic dissection
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 thoracoabdominal aneurysm repairEndovascular treatment of patients with thoracoabdominal aneurysm using a multibranch stent graft tailored to the patient´s anatomy in combination with peripheral covered stents to bridge the visceral arteries | Device | – |
Primary outcome
Rate of patients with stable or decreasing aneurysm size at 12 months follow-up (measured by CoreLab)
Time frame: 12 months follow-up
Decreasing size: >/= 5mm Increasing size: </= 5mm compared to first post-operative CT angiogram
13 secondary outcomes
Rate of all cause mortality
Time frame: intra-op, post-op until 36 months follow-up
Rate of patients with aneurysm rupture
Time frame: post-op until 36 months follow-up
Rate of patients with main adverse events (product-related, procedure-related, aneurysm-related)
Time frame: post-op until 36 months follow-up
Rate of interventions in peri-operative periods (all related interventions until index procedure)
Time frame: intra-op
Rate of reinterventions
Time frame: post-op until 36 months follow-up
Rate of patients with endoleaks type Ia, Ib, II, III, IV, V and of unknown origin
Time frame: post-op until 36 months follow-up
Rate of patients with multi-branch stent graft migration
Time frame: post-op until 36 months follow-up
Rate of patients with loss of device integrity
Time frame: post-op until 36 months follow-up
Rate of patients with primary / secondary patency of branch vessels
Time frame: post-op until 36 months follow-up
Rate of patients with stent graft infection
Time frame: post-op until 36 months follow-up
Rate of patients with primary / secondary technical success
Time frame: post-op until 36 months follow-up
Rate of patients with primary / secondary clinical success
Time frame: post-op until 36 months follow-up
Rate of patients with removal or failure to implant the multi-branch stent graft
Time frame: intra-op, post-op until 36 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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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.
Hubert Schelzig, Professor study director
Uniklinikum Düsseldorf
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 Thoracoabdominal 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 7 inclusion and 14 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: finished, as of the sponsor's last update on 17 Feb 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of patients with stable or decreasing aneurysm size at 12 months follow-up (measured by CoreLab) (time frame: 12 months follow-up). 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 17 Feb 2026.