Aortic Remodeling After Endovascular Management of Type B Aortic Dissection.

February 25, 2024 updated by: Mohamed hesham abdelrahem husiein, Assiut University
Assess the clinical outcome, morphological changes and behaviour of type B aortic dissection after endovascular repair.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Aortic dissection (AD) is considered the most common catastrophic event of the aorta, and its incidence has been reported to be ≈3/100000 per year, exceeding that of ruptured abdominal aortic aneurysm.

AD is a dynamic process and can occur anywhere along the course of the aorta, with the pathognomonic lesion being an intimal tear followed by blood surging either antegrade (typically) or retrograde, cleaving the the intima and medial layers of the aortic wall longitudinally for a variable distance, thus creating a true and false lumens.

Aortic dissections are classified by chronicity, anatomic location of false lumen, generally the entry tear and longitudinal extent, and the presence or absence of complicating features.

Temporally, AD is categorized as acute phase {<14 days}, subacute {15-90 days}, and chronic {>90 days}.

Thoracic Endovascular Aortic Repair (TEVAR) has emerged as the first-line therapy for the treatment of AD, with better short-term results than open repair due to a significant decrease in perioperative morbidity and mortality.

By covering the primary entry tear with stent-grafts, the blood flow is redirected into the true lumen, resolving malperfusion and/or preventing rupture of the false lumen, followed by its regression and re-expansion of the true lumen, which is known as "Aortic remodeling"

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Asyut, Egypt, 71515
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

complicated or high-risk acute, subacute or chronic type B aortic dissection.

Description

Inclusion Criteria:

  1. Complicated Stanford type B dissections:

    • Rupture.
    • malperfusion (visceral, extremities or spinal cord ischemia).

  2. High-risk aortic dissections:

    • Refractory pain, refractory hypertension or bloody pleural effusion.
    • High-risk radiographic features (max. aortic diameter >40mm, false lumen diameter >22mm, 1ry entry tear >1cm, entry tear location on the lesser curve and radiographic only malperfusin).

  3. Aortic anatomy suitable for stent graft therapy:

    • Proximal landing zone (diameters between 15 and 42mm, measured form outer wall to outer wall) isn't aneurysmal, dissected or significantly thrombosed.
    • Proximal landing zone length ≥20mm.
    • Radius of curvature ≥20mm for aortic arch landing zones.
    • Arch or distal aortic angulation 45≤ degrees.
  4. Compatible Iliac and/or femoral access vessel morphology (diameter and tortousity) that allows endovascular access to the dissection site with the delivery system of the appropriately sized device, with or without the use of either surigcal or endovascular conduit.
  5. Age ≥18yrs.
  6. Life expectancy >2yrs

Exclusion Criteria:

  1. Known hypersensitivity to device component or contraindication to anticoagulation or contrast media.
  2. Systemic or local infection that may increase the risk of endovascular graft infection.
  3. Subjects with past descending or abdominal aortic interventions.
  4. Un-correctable coagulopathy
  5. Active vasculitis
  6. Inability or refusal to give informed consent by subject or legal representative
  7. Subject is unwilling to comply with the follow-up schedule.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of aortic remodeling
Time Frame: 2 years
evaluation of diameter changes between the preoperative and postoperative CTs measurements in millimetres . The true lumen index (Tli) is calcuated by dividing thr true lumen diameter by the whole lumen (transaortic) diameter. The fasle lumen index (Fli) is calculated in the same manner. The desirable TLi value approaches or equals 1 (suggesting increase in true lumen to normal), whereas the sought-after FLi value approaches or equals 0 (suggesting shrinkage in false lumen).
2 years
technical success
Time Frame: baseline
successful delivery and deployment of the device with coverage of the 1ry tear at implant with no detected endoleak on angiography
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

February 17, 2024

First Submitted That Met QC Criteria

February 25, 2024

First Posted (Estimated)

March 4, 2024

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 25, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • aortic remodeling

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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