Aortic Aneurysm, AbdominalNCT03310710
VIABAHN BX Used in Fenestrated EVAR Study
A study testing Viabahn BX stent in people with Aortic Aneurysm, Abdominal, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- Viabahn BX stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 13 Feb 2017to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fenestrated EVAR candidates as determined by the vascular interdisciplinary conference at UHN
Who cannot join
- Unable to provide informed consent (legally authorized representative is acceptable)
- Age < 18
- Patients with a known hypersensitivity to heparin, including those patients who have had a previous incidence of HIT (heparin induced thrombocytopenia) type II.
- Currently participating in another investigative clinical study
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Toronto General Hospital
Toronto, Ontario, M5G 2N2
About this study
Official title: Heparin Bonded Balloon-expandable Stent Grafts for Branches of a Fenestrated Endovascular Aortic Repair Graft
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.
Read the detailed description
FEVAR branches can occlude jeopardizing perfusion of the organs they supply. A recent study has shown the rate of patency as 95.7% at 1 year and 88.6% at 4 years. Pooled analysis has shown a 4.5% rate of renal artery occlusion during 12 month follow up with 2.3% going on to dialysis and 1.4% requiring permanent dialysis. 1.8% of patients can go on to have mesenteric stenosis though these have been due to technical issues with the stents.
Studies have previously shown that the patency of vascular grafts can be improved by bonding heparin bonding to the surface of a graft material. For example in surgical bypass a Dacron graft bonded with heparin outperformed a conventional PTFE graft in terms of patency and clinical outcomes. Endovascular stent grafting with heparin bonded PTFE has also been shown to be superior to PTFE alone with a primary patency of 86.4% vs 79.9% in femoropopliteal disease. A recent trial has demonstrated impressive patency of 73% in long segment femoropopliteal disease (TASC C and D lesions) using a self expanding version of the heparin bonded, covered, Viabahn stent graft. Heparin bonded stent grafts have shown promise in preserving patency of other vessels. A pilot study demonstrating the safety of using the Viabahn Bx in FEVAR will support the rationale for larger studies of this question including randomization between conventional and heparin bonded stent grafts.
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- Viabahn BX stent
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viabahn BX stentDevice
Viabahn BX stent graft used as the branch device with a fenestrated EVAR graft
| Study group | Role | What they receive |
|---|---|---|
| treatment with Viabahn BX stent | Experimental | Treatment with Viabahn BX stent as branch device in fenestrated EVAR Receives: Device: Viabahn BX stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success related the Viabahn BX stent graft when used as the branch device with a fenestrated EVAR graft.
Successful deployment of the Viabahn BX stent graft without major adverse events, such as occlusion of the arteries, at the end of the fenestrated EVAR surgery.
Measured: Intraoperative (End of EVAR surgery)
Adverse event related to the Viabahn BX stent graft when used as the branch device with a fenestrated EVAR graft.
Any stent related adverse event, such as occlusion of the stent and stent fracture
Measured: 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start13 Feb 2017
- Primary completion17 Oct 2018
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Treatment with Viabahn BX stents
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kongteng Tan, University Health Network, Toronto
- Investigators
- Kong Teng Tan, MD, Principal investigator, University Health Network, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310710
- Sponsor's protocol ID
- CAPCR 16-5084
- Status last verified
- Nov 2023
- First submitted
- 5 Oct 2017
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparin Bonded Balloon-expandable Stent Grafts for Branches of a Fenestrated Endovascular Aortic Repair Graft
- ClinicalTrials.gov ID
- NCT03310710
- Acronym / sponsor ID
- CAPCR 16-5084
- Conditions
- Aortic Aneurysm, Abdominal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 17 Oct 2018 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
FEVAR branches can occlude jeopardizing perfusion of the organs they supply. A recent study has shown the rate of patency as 95.7% at 1 year and 88.6% at 4 years. Pooled analysis has shown a 4.5% rate of renal artery occlusion during 12 month follow up with 2.3% going on to dialysis and 1.4% requiring permanent dialysis. 1.8% of patients can go on to have mesenteric stenosis though these have been due to technical issues with the stents.
Studies have previously shown that the patency of vascular grafts can be improved by bonding heparin bonding to the surface of a graft material. For example in surgical bypass a Dacron graft bonded with heparin outperformed a conventional PTFE graft in terms of patency and clinical outcomes. Endovascular stent grafting with heparin bonded PTFE has also been shown to be superior to PTFE alone with a primary patency of 86.4% vs 79.9% in femoropopliteal disease. A recent trial has demonstrated impressive patency of 73% in long segment femoropopliteal disease (TASC C and D lesions) using a self expanding version of the heparin bonded, covered, Viabahn stent graft. Heparin bonded stent grafts have shown promise in preserving patency of other vessels. A pilot study demonstrating the safety of using the Viabahn Bx in FEVAR will support the rationale for larger studies of this question including randomization between conventional and heparin bonded stent grafts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment with Viabahn BX stents
| Arm | Type | Receives |
|---|---|---|
| treatment with Viabahn BX stent | Experimental | Device: Viabahn BX stentTreatment with Viabahn BX stent as branch device in fenestrated EVAR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fenestrated EVAR candidates as determined by the vascular interdisciplinary conference at UHN
Key exclusion criteria (4 listed)
- Unable to provide informed consent (legally authorized representative is acceptable)
- Age < 18
- Patients with a known hypersensitivity to heparin, including those patients who have had a previous incidence of HIT (heparin induced thrombocytopenia) type II.
- Currently participating in another investigative clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viabahn BX stentViabahn BX stent graft used as the branch device with a fenestrated EVAR graft | Device | treatment with Viabahn BX stent |
Primary outcome
Technical success related the Viabahn BX stent graft when used as the branch device with a fenestrated EVAR graft.
Time frame: Intraoperative (End of EVAR surgery)
Successful deployment of the Viabahn BX stent graft without major adverse events, such as occlusion of the arteries, at the end of the fenestrated EVAR surgery.
Adverse event related to the Viabahn BX stent graft when used as the branch device with a fenestrated EVAR graft.
Time frame: 12 months post surgery
Any stent related adverse event, such as occlusion of the stent and stent fracture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
Related trials for Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
AneuFix - Prophylactic Sac Filling
Abdominal Aortic Aneurysm, Endoleak
Active, not recruiting
ANEUFIX for Endoleak Type II Repair
Abdominal Aortic Aneurysm, Endoleak
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kong Teng Tan, MD principal investigator
University Health Network, Toronto General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viabahn BX stent in people with Aortic Aneurysm, Abdominal, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success related the Viabahn BX stent graft when used as the branch device with a fenestrated EVAR graft. (time frame: Intraoperative (End of EVAR surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.