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Intravascular Ultrasound for the Evaluation of Malperfusion Syndrome in the Setting of Acute Aortic Dissection

NCT04907071 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-15

No results posted yet for this study

Summary

Aortic dissection is a life-threatening condition caused by a tear in the internal layer of major artery wall (aorta) that carries blood to all body organs, resulting in separation of the aortic wall layers (dissection). The dissected aorta compromises blood flow to any organ, and eventually leads to organ damage (Malperfusion Syndrome).

Our goal in this project is to use Intravascular Ultrasound (IVUS) to have real time assessment and confirm any evidence of malperfusion syndrome in the setting of aortic dissection after repairing the original aortic tear. IVUS is a small ultrasound (sound waves) wand that is attached to the top of a thin tube. This tube is inserted into the aorta from the groin. This device takes pictures of the aorta and its major branches, to identify problems with blood flow. Having this real-time and dynamic assessment will help to identify any malperfused organs before leaving the operating room and allow us to address the malperfusion syndrome as quickly as possible to limit complications. Without this technique, identifying the problem can take several days after surgery at which point there can be irreversible complications.

Conditions

  • Aortic Dissection
  • Perfusion; Complications

Interventions

DEVICE

Intravascular ultrasound 0.035 PV IVUS catheter (Volcano Therapeutics, Rancho Cordova, CA)

The investigational 0.035 PV IVUS catheter (Volcano Therapeutics, Rancho Cordova, CA) is an over the wire catheter-based ultrasound with an 8.2-French profile at the transducer end and 7.0-French shaft diameter. This is run through a 9-French place under surface ultrasound guidance in the common femoral artery. The working length of this catheter is 90 cm, with the ability to imaging a diameter up to 60 mm.7

Sponsors & Collaborators

  • London Health Sciences Centre

    lead OTHER

Principal Investigators

  • Mathew Valdis, MD, FRCSC · London Health Sciences Center , London, Ontario, Canada

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2025-12-30
Completion
2025-12-30
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04907071 on ClinicalTrials.gov