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

NCT04907071 | Completed DMC FDA Device

• 1 other identifier: AAD IVUS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Malperfusion; Syndrome

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

  Composite of all-cause in hospital mortality, acute kidney injury requiring new dialysis, mesenteric ischemia requiring intervention and major vascular complications.

  30 days

• Primary Effectiveness Endpoint

  Composite of all-cause in hospital mortality, acute kidney injury requiring dialysis, mesenteric ischemia requiring surgical resection and major vascular complications.

  30 days

Secondary Outcomes (1)

• Secondary Effectiveness Endpoint

  30 days

Study Arms (3)

Malperfusion Primary Cohort

EXPERIMENTAL

Patients presenting to hospital with AAD meeting criteria for malperfusion syndrome preoperatively which includes both components: * Imaging findings indicating reduced flow to the Celiac Trunk, Superior mesenteric artery, either renal artery or either iliac artery * Clinical stigmata of end organ ischemia (abdominal pain, distended abdomen, oliguria/anuria, reduced pulses, signs of limb ischemia) OR Laboratory findings suggestive of end organ ischemia (lactic acidosis, elevated LFTs, Elevated Creatinine, Rhabdomyolysis, Electrolyte abnormalities)

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

Malperfusion Secondary Cohort:

EXPERIMENTAL

Patients who develop new clinical signs or laboratory results indicating distal malperfusion after proximal repair of the AAD is complete and proximal blood flow is redirected into the true lumen. * New Clinical signs include: Loss of femoral pulses, distended abdomen, reduced urine output, dusky extremities * New Laboratory signs include: Rising lactate (\>50% above baseline), Rising Creatinine, Metabolic Acidosis, Rising LFTs

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

No Malperfusion Cohort

EXPERIMENTAL

Patients presenting with AAD with no evidence of malperfusion syndrome preoperatively and postoperatively.

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

Interventions

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

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

Malperfusion Primary Cohort; Malperfusion Secondary Cohort:; No Malperfusion Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with an AAD or acute on chronic aortic dissection, with a new diagnosis of malperfusion syndrome (Malperfusion Primary Cohort), by meeting both of the following criteria:
• Imaging findings indicating reduced flow to the Celiac Trunk, Superior mesenteric artery, either renal artery or either iliac artery
• Clinical stigmata of end organ ischemia (abdominal pain, distended abdomen, oliguria/anuria, reduced pulses, signs of limb ischemia) correlating with imaging findings
• o Laboratory findings suggestive of end organ ischemia (lactic acidosis, elevated LFTs, Elevated Creatinine, Rhabdomyolysis, Electrolyte abnormalities) correlating with imaging findings
• Patients diagnosed with an AAD undergoing surgical repair without evidence of malperfusion syndrome preoperatively, but who develop malperfusion syndrome due to dynamic flow changes after true lumen flow is reinstituted intraoperatively as indicated by new clinical signs or new laboratory results meeting the following criteria (Malperfusion Secondary Cohort):
• New Clinical signs include: Loss of femoral pulses, distended abdomen, reduced urine output, dusky/cold extremities
• New Laboratory results include: Rising lactate (\>50% above baseline), Rising Creatinine, Metabolic Acidosis, Rising LFTs
• Patients diagnosed with an AAD undergoing surgical repair without evidence of malperfusion syndrome preoperatively and postoperatively (No Malperfusion Cohort).

You may not qualify if:

• Subject has not been diagnosed with AAD, or acute on chronic aortic dissection
• Subject is not hemodynamically stable to undergo IVUS evaluation
• Subject has anatomy or pre-existing condition precluding safe use of IVUS evaluation
• Subject has a pre-existing condition that may explain evidence of malperfusion (i.e. Dialysis patient with severe renal stenosis).
• Subject or substitute decision maker has language barrier and no translator available at the time of obtaining informed consent to participate in the study.

Sponsors & Collaborators

• London Health Sciences Centre: lead

Study Sites (1)

London Health Scince Center - University Hospital

London, Ontario, N5X0M5, Canada

Location

Related Publications (7)

• Tsai T, Nienaber CA, Isselbacher EM, Trimarchi S, Bossone E, Evangelista A, Oh JK, O'Gara P, Suzuki T, Hutchison S, Cooper JV, Meinhardt G, Myrmel T, Eagle KA, Froehlich J. Acute type A aortic dissection: does a primary tear in the aortic arch affect management and outcomes? Insights from the International Registry of Acute Aortic Dissection (IRAD). Circulation 2006; 114:432.8.

  BACKGROUND

• HIRST AE Jr, JOHNS VJ Jr, KIME SW Jr. Dissecting aneurysm of the aorta: a review of 505 cases. Medicine (Baltimore). 1958 Sep;37(3):217-79. doi: 10.1097/00005792-195809000-00003. No abstract available.

  PMID: 13577293 RESULT

• Collins JS, Evangelista A, Nienaber CA, Bossone E, Fang J, Cooper JV, Smith DE, O'Gara PT, Myrmel T, Gilon D, Isselbacher EM, Penn M, Pape LA, Eagle KA, Mehta RH; International Registry of Acute Aortic Dissection (IRAD). Differences in clinical presentation, management, and outcomes of acute type a aortic dissection in patients with and without previous cardiac surgery. Circulation. 2004 Sep 14;110(11 Suppl 1):II237-42. doi: 10.1161/01.CIR.0000138219.67028.2a.

  PMID: 15364869 RESULT

• Yang B, Rosati CM, Norton EL, Kim KM, Khaja MS, Dasika N, Wu X, Hornsby WE, Patel HJ, Deeb GM, Williams DM. Endovascular Fenestration/Stenting First Followed by Delayed Open Aortic Repair for Acute Type A Aortic Dissection With Malperfusion Syndrome. Circulation. 2018 Nov 6;138(19):2091-2103. doi: 10.1161/CIRCULATIONAHA.118.036328.

  PMID: 30474418 RESULT

• Valdis M, Adams C, Chu MWA, Kiaii B, Guo L. Comparison of outcomes of root replacement procedures and supracoronary techniques for surgical repair of acute aortic dissection. Can J Surg. 2017 Jun;60(3):198-204. doi: 10.1503/cjs.009116.

  PMID: 28570214 RESULT

• Hagan PG, Nienaber CA, Isselbacher EM, Bruckman D, Karavite DJ, Russman PL, Evangelista A, Fattori R, Suzuki T, Oh JK, Moore AG, Malouf JF, Pape LA, Gaca C, Sechtem U, Lenferink S, Deutsch HJ, Diedrichs H, Marcos y Robles J, Llovet A, Gilon D, Das SK, Armstrong WF, Deeb GM, Eagle KA. The International Registry of Acute Aortic Dissection (IRAD): new insights into an old disease. JAMA. 2000 Feb 16;283(7):897-903. doi: 10.1001/jama.283.7.897.

  PMID: 10685714 RESULT

• Kpodonu J, Ramaiah VG, Diethrich EB. Intravascular ultrasound imaging as applied to the aorta: a new tool for the cardiovascular surgeon. Ann Thorac Surg. 2008 Oct;86(4):1391-8. doi: 10.1016/j.athoracsur.2008.06.057.

  PMID: 18805213 RESULT

MeSH Terms

Conditions

Aortic Dissection; Syndrome

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mathew Valdis, MD, FRCSC

  London Health Sciences Center , London, Ontario, Canada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Surgery Resident

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: March 1, 2022
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)