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Registry in Patients With Thoracoabdominal Aneurysms (CONNECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03295682
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
JOTEC GmbH

Brief 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.

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.


Condition or disease Intervention/treatment
Thoracoabdominal Aneurysm Device: Endovascular thoracoabdominal aneurysm repair

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: Registry in Patients With Thoracoabdominal Aneurysms Treated With Multi-branch Stent Grafts Tailored to Their Individual Anatomies
Actual Study Start Date : September 11, 2017
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy Aneurysms


Intervention Details:
  • Device: Endovascular thoracoabdominal aneurysm repair
    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


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Rate of all cause mortality [ Time Frame: intra-op, post-op until 36 months follow-up ]
  2. Rate of patients with aneurysm rupture [ Time Frame: post-op until 36 months follow-up ]
  3. Rate of patients with main adverse events (product-related, procedure-related, aneurysm-related) [ Time Frame: post-op until 36 months follow-up ]
  4. Rate of interventions in peri-operative periods (all related interventions until index procedure) [ Time Frame: intra-op ]
  5. Rate of reinterventions [ Time Frame: post-op until 36 months follow-up ]
  6. 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 ]
  7. Rate of patients with multi-branch stent graft migration [ Time Frame: post-op until 36 months follow-up ]
  8. Rate of patients with loss of device integrity [ Time Frame: post-op until 36 months follow-up ]
  9. Rate of patients with primary / secondary patency of branch vessels [ Time Frame: post-op until 36 months follow-up ]
  10. Rate of patients with stent graft infection [ Time Frame: post-op until 36 months follow-up ]
  11. Rate of patients with primary / secondary technical success [ Time Frame: post-op until 36 months follow-up ]
  12. Rate of patients with primary / secondary clinical success [ Time Frame: post-op until 36 months follow-up ]
  13. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A total number of 40 male and female patients with asymptomatic thoracoabdominal aortic aneurysm, treated with a multi-branch stent graft system.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295682


Contacts
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Contact: Heike Fischer, Dr. +49 151 153 97 110 heike.fischer@jotec.com

Locations
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Germany
Uniklinikum Düsseldorf Recruiting
Düsseldorf, NRW, Germany, 40225
Contact: Hubert Schelzig, Professor    +49 211 81 17090      
Sponsors and Collaborators
JOTEC GmbH
Investigators
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Study Director: Hubert Schelzig, Professor Uniklinikum Düsseldorf
Additional Information:

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Responsible Party: JOTEC GmbH
ClinicalTrials.gov Identifier: NCT03295682    
Other Study ID Numbers: CONNECT
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneurysm
Vascular Diseases
Cardiovascular Diseases