Who is sponsoring NCT03637374?

NCT03637374 is sponsored by Johns Hopkins University.

What drugs are being tested in NCT03637374?

Interventions in NCT03637374: Visceral Manifold and Thoracic Bifurcation, Unitary Manifold, TAAA Debranching Stent Graft System.

What condition does NCT03637374 study?

NCT03637374 studies Thoracoabdominal Aortic Aneurysm.

Is NCT03637374 still recruiting?

NCT03637374 is currently terminated. Last updated 19 August 2022.

Are results published for NCT03637374?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-08-19 · How we verify

NCT03637374

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

Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device

Terminated NA Results posted Last updated 19 August 2022

What this trial tests

NA trial testing Visceral Manifold and Thoracic Bifurcation in Thoracoabdominal Aortic Aneurysm in 2 participants. Terminated before completion.

Timeline

8 September 2020

Primary endpoint
21 March 2022

6 June 2022

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	8 September 2020
Primary completion	21 March 2022
Estimated completion	6 June 2022
Sites	1 location across United States

Drugs / interventions tested

Visceral Manifold and Thoracic Bifurcation
Unitary Manifold
TAAA Debranching Stent Graft System

Conditions studied

Thoracoabdominal Aortic Aneurysm — all drugs for Thoracoabdominal Aortic Aneurysm →

Sponsor

Johns Hopkins University

Who can join

18 and older, any sex, with Thoracoabdominal Aortic Aneurysm. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Freedom From Major Adverse Events (MAEs) at 30 Days Primary · 30 days

Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.

Group	Value	95% CI
Primary Study Arm	1
Expanded Selection Arm	0

Treatment Success at 1 Year Secondary · 1 year

Treatment success is defined as a composite of technical success and freedom from the following: Aneurysm enlargement, Aneurysm rupture, Aneurysm-related mortality, Conversion to open repair, Secondary intervention for migration, Type I and III endoleaks, device integrity failure, and patency-related events.

Group	Value	95% CI
Primary Study Arm	0
Expanded Selection Arm	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Primary Study Arm

Serious: 1/2 (50%)

Deaths: 2/2

Expanded Selection Arm

Serious: 0

Deaths: 0

Serious adverse events (1 terms)

Reaction	System	Primary Study Arm	Expanded Selection Arm
bowel ischemia	Gastrointestinal disorders	—	—

Most-reported serious reactions: bowel ischemia.

Data from ClinicalTrials.gov NCT03637374 adverse events section.

Sponsor's own description

The primary purpose of this study is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy, as measured by device safety, effectiveness, costs of delivery of aortic surgery care, and patient quality of life domains. Additionally, the study will assess technical success and treatment success at each follow-up interval.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Thoracoabdominal Aortic Aneurysm

Currently open trials in the same condition.

NCT07147569 — TAMBE Japan Post-Marketing Surveillance · recruiting
NCT06478576 — Study on Multibranched Stent Graft System in the Treatment of Thoracoabdominal Aortic Aneurysm · NA · recruiting
NCT05758844 — The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Exclusion of TAAA · recruiting
NCT06969729 — Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology · NA · recruiting
NCT07141251 — Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02) · Phase 1 · recruiting

Other Johns Hopkins University trials

Trials by the same sponsor.

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NCT06687655 — Impact of Exogenous Ketones on Sleep Apnea · Phase 1, PHASE2 · not yet recruiting
NCT07079111 — 3D Printed Occlusal Splints for Intraoperative Use · NA · not yet recruiting
NCT02998502 — The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens · 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 NCT03637374 (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 Johns Hopkins University
Last refreshed: 19 August 2022

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/NCT03637374.

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