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NCT03310710
VIABAHN BX Used in Fenestrated EVAR Study
NA trial testing Viabahn BX stent in Aortic Aneurysm, Abdominal in 20 participants. Completed in 1 November 2019.
17 October 2018
Quick facts
| Lead sponsor | University Health Network, Toronto |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 13 February 2017 |
| Primary completion | 17 October 2018 |
| Estimated completion | 1 November 2019 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Viabahn BX stent
Conditions studied
- Aortic Aneurysm, Abdominal — all drugs for Aortic Aneurysm, Abdominal →
Sponsor
University Health Network, Toronto
Who can join
18 and older, any sex, with Aortic Aneurysm, Abdominal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Fenestrated endovascular abdominal aortic aneurysm repair (FEVAR) is a procedure to treat abdominal aortic aneurysms which are not amenable to conventional repair or stenting. A stent is placed in the aorta and confines blood flow to a normal diameter lumen to remove pressure on the diseased aortic wall. Fenestrations (custom holes in the graft) are necessary to maintain blood flow to abdominal organs when the aneurysm sac extends to far proximally. These fenestrations are then typically aligned with their respective vessels using covered stents. These stents also help keep the arteries open. Unfortunately some of the stents currently used occlude either immediately or over time, which can lead to organ failure, morbidity and death. A recent advancement in stent design has heparin bonded to the stent surface which prevents clot from forming. This new design has been shown to help maintain stent patency in other parts of the body. The investigators believe it may do the same for FEVAR patients. The proposed study is a 20-patient pilot to assess the safety of substituting a heparin bonded stent graft for FEVAR branches over a period of one year. Patients who are deemed eligible for FEVAR by a UHN multidisciplinary vascular conference will be recruited to the study. All the branches in their FEVAR will use the Viabahn BX stent in place of the current standard of care stent. They will then be followed per the standard of care for one year. Adverse events will be recorded and the rate of occlusion will be assessed based on CT imaging. The investigators hypothesize that using heparin bonded stent grafts is safe and they will have a low rate of occlusion.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03310710
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Aortic Aneurysm, Abdominal
Currently open trials in the same condition.
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- NCT04503395 — ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES · NA · recruiting
- NCT05360108 — Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm · active not recruiting
- NCT02489539 — Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms · NA · active not recruiting
Other University Health Network, Toronto trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03310710 (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: 28 November 2023
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/NCT03310710.
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