Who is sponsoring NCT03998631?

NCT03998631 is sponsored by University Health Network, Toronto.

What drugs are being tested in NCT03998631?

Interventions in NCT03998631: Carbon Dioxide and Saline Flush, Standard Saline Flush.

What condition does NCT03998631 study?

NCT03998631 studies Thoracic Aortic Aneurysm, Aortic Stenosis Symptomatic, Stroke, Complication.

Is NCT03998631 still recruiting?

NCT03998631 is currently status unknown. Last updated 23 September 2020.

Last reviewed 2020-09-23 · How we verify

NCT03998631

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Comparison of Carbon Dioxide and Saline Flush to Saline Flush in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia

Status unknown Phase 1 Last updated 23 September 2020

What this trial tests

Phase 1 trial testing Carbon Dioxide and Saline Flush in Thoracic Aortic Aneurysm in 20 participants. Status unknown.

Timeline

20 July 2019

Primary endpoint
31 December 2020

31 March 2021

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	20 July 2019
Primary completion	31 December 2020
Estimated completion	31 March 2021
Sites	1 location across Canada

Drugs / interventions tested

Carbon Dioxide and Saline Flush
Standard Saline Flush

Conditions studied

Thoracic Aortic Aneurysm — all drugs for Thoracic Aortic Aneurysm →
Aortic Stenosis Symptomatic — all drugs for Aortic Stenosis Symptomatic →
Stroke, Complication — all drugs for Stroke, Complication →

Sponsor

University Health Network, Toronto

Who can join

18 and older, any sex, with Thoracic Aortic Aneurysm or Aortic Stenosis Symptomatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Thoracic endovascular repair (TEVAR) and transcatheter aortic valve implantation (TAVI) are standard of care procedures to treat thoracic aortic aneurysm or severe aortic stenosis, respectively. Both procedures have a high risk of stroke and silent infarction. Gas has been detected in the cerebral vasculature during these procedures and associated with DWI positive lesions on MRI. The hypothesis is that air emboli contribute to stroke and silent infarction. The investigators propose addressing air emboli by flushing the device with carbon dioxide prior to flushing with saline. This is a pilot study comparing standard saline flush alone to carbon dioxide flushing with saline flush.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Thoracic Aortic Aneurysm

Currently open trials in the same condition.

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NCT06882967 — Active Thoracic Compromised Distal LANding in TEvar · recruiting

Other University Health Network, Toronto trials

Trials by the same sponsor.

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NCT07509450 — Fecal Microbiota Transplantation in Patients Undergoing Chimeric Antigen Receptor T-cell Therapy and Allogeneic Stem Cel · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03998631 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Health Network, Toronto
Last refreshed: 23 September 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03998631.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing