Juxtarenal Aortic AneurysmNCT04252079
Endovascular Repair of Juxtarenal Aortic Aneurysm
A study testing Endovascular Repair of Juxtarenal Aortic Aneurysm in people with Juxtarenal Aortic Aneurysm, run by Assiut University.
Trial summary
The investigators compare different endovascular techniques as an alternative to surgical reconstruction to repair JAAS regarding ; success rates, 30-day mortality,endoleak events secondary intervention rates Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Juxtarenal Aortic Aneurysm
- What is being tested?
- Endovascular Repair of Juxtarenal Aortic Aneurysm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 1 Sep 2021
- 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
- • Subject is ≥18 years old
- Subject is scheduled for treatment of the juxtarenal aortic aneurysm with a short infrarenal neck aortic neck length <15 mm, neck angulation >60%, conical neck) (i.e. denovo cases).
- Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.
- Subject has provided written informed consent.
Who cannot join
- Subject is participating in a concurrent study which may confound study results
- Subject has a life expectancy ≤1 year
- Subject has an aneurysm that is:
- Mycotic
- Inflammatory
- Pseudoaneurysm
Show all 10Show fewer
- Subject requires emergent aneurysm treatment, for example, trauma or rupture
- Subject has previously undergone surgical treatment for abdominal aortic aneurysm
- Subject is a female of childbearing potential in whom pregnancy cannot be excluded
- Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment.
Trial locations and contacts
No sites are listed yet.
About this study
The investigators compare different endovascular techniques as an alternative to surgical reconstruction to repair JAAS regarding ; success rates, 30-day mortality,endoleak events secondary intervention rates
Read the detailed description
Aortic disease is the direct cause of close to 10000 deaths annually in the United States. 1
Aneurysmal disease can affect any segment of the aorta, from the aortic root to the aortic bifurcation. Juxtarenal Aortic Aneurysms (JAA) (where a specialty designed custom -made device (endograft)which has holes, or fenestrations ,on the graft body to maintain the patency of the visceral arteries) account for approximately 15% of abdominal aortic aneurysms.2
Successful aortic aneurysm treatment depends on either open replacement or endovascular exclusion of the aneurysmal segment with healthy artery proximal and distal to the repair.
The decision to treat an AAA is based on the associated risk of treatment, the risk of aneurysm rupture, the patient's life expectancy, and patient preference.
The primary determinant of rupture risk is maximum aneurysm diameter, with negligible rupture risk in aneurysms <4cm in diameter compared with aneurysms >8 cm . 3, 4.
The Society for Vascular Surgery recommends repair for all patients of acceptable perioperative risk with an AAA ≥5.5 cm in diameter as well as all patients with saccular and symptomatic aneurysms.5 ,6
These guidelines also suggest repair for women at a diameter of 5.0 cm.
Fenestrated Endovascular Aneurysm Repair (FEVAR) and Chimney Endovascular Aneurysm Repair (CHEVAR)are both effective methods to treat JAAs
- Conditions
- Juxtarenal Aortic Aneurysm
- Being tested
- Endovascular Repair of Juxtarenal Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Repair of Juxtarenal Aortic AneurysmProcedure or surgery
- History taking and clinical examination.
- Preoperative Imaging CTA is the cross-sectional imaging modality of choice.
- Preoperative evaluation a-Renal evaluation b_ cardiac evaluation C-Pulmonary evaluation
- Surgical techniques
- Anesthesia The use of general anesthesia due to the duration of the procedures and the necessity to control patient breathing to allow precise imaging and accurate device deployment.
- Intra operative imaging A "hybrid" operating room with high-quality fixed imaging is needed for the performance of FEVAR.
C-Device delivery and deployment all FEVAR procedures begin with access of the femoral arteries by either open or percutaneous technique.
| Study group | Role | What they receive |
|---|---|---|
| We compare different endovascular techniques as an alternative | Other | We compare different endovascular techniques as an alternative to surgical reconstruction to repair JAAS regarding ; success rates, 30-day mortality, endoleak events secondary intervention rates Receives: Procedure: Endovascular Repair of Juxtarenal Aortic Aneurysm |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be clinical success .
Clinical success will be evaluated by Measurment of blood pressure by sphygmomanometer in mmhg Serum creatinine level in mg/dL
Measured: One year
One year patency of the endovascular graft
One year patency will be assessed by CT angiography ( if it is patent or not).
CT angiography can detect successful deployment of the endovascular device at the intended location or post endograft complications as type I or III endoleak , graft thrombosis, aneurysm expansion , aneurysm rupture.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Juxtarenal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Prospective cross sectional study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Mohamed Awad Hassan, Assiut University
- Investigators
- Ashraf G Taha, MD, Study director, Assistant professur Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252079
- Sponsor's protocol ID
- Aortic aneurysm repair
- Status last verified
- Jan 2020
- First submitted
- 18 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Taylor SM, Mills JL, Fujitani RM. The juxtarenal abdominal aortic aneurysm. A more common problem than previously realized? Arch Surg. 1994 Jul;129(7):734-7. doi: 10.1001/archsurg.1994.01420310066011.
PubMed 8024454Brown LC, Powell JT. Risk factors for aneurysm rupture in patients kept under ultrasound surveillance. UK Small Aneurysm Trial Participants. Ann Surg. 1999 Sep;230(3):289-96; discussion 296-7. doi: 10.1097/00000658-199909000-00002.
PubMed 10493476Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2. doi: 10.1016/j.jvs.2017.10.044.
PubMed 29268916Moll FL, Powell JT, Fraedrich G, Verzini F, Haulon S, Waltham M, van Herwaarden JA, Holt PJ, van Keulen JW, Rantner B, Schlosser FJ, Setacci F, Ricco JB; European Society for Vascular Surgery. Management of abdominal aortic aneurysms clinical practice guidelines of the European society for vascular surgery. Eur J Vasc Endovasc Surg. 2011 Jan;41 Suppl 1:S1-S58. doi: 10.1016/j.ejvs.2010.09.011. No abstract available.
PubMed 21215940Greenberg R, Eagleton M, Mastracci T. Branched endografts for thoracoabdominal aneurysms. J Thorac Cardiovasc Surg. 2010 Dec;140(6 Suppl):S171-8. doi: 10.1016/j.jtcvs.2010.07.061.
PubMed 21092788Coselli JS, LeMaire SA, Preventza O, de la Cruz KI, Cooley DA, Price MD, Stolz AP, Green SY, Arredondo CN, Rosengart TK. Outcomes of 3309 thoracoabdominal aortic aneurysm repairs. J Thorac Cardiovasc Surg. 2016 May;151(5):1323-37. doi: 10.1016/j.jtcvs.2015.12.050. Epub 2016 Jan 14.
PubMed 26898979Eagleton MJ, Follansbee M, Wolski K, Mastracci T, Kuramochi Y. Fenestrated and branched endovascular aneurysm repair outcomes for type II and III thoracoabdominal aortic aneurysms. J Vasc Surg. 2016 Apr;63(4):930-42. doi: 10.1016/j.jvs.2015.10.095. Epub 2016 Jan 11.
PubMed 26792544
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Repair of Juxtarenal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT04252079
- Acronym / sponsor ID
- Aortic aneurysm repair
- Conditions
- Juxtarenal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 5 Feb 2020 (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.
The investigators compare different endovascular techniques as an alternative to surgical reconstruction to repair JAAS regarding ; success rates, 30-day mortality,endoleak events secondary intervention rates
Detailed description
Aortic disease is the direct cause of close to 10000 deaths annually in the United States. 1
Aneurysmal disease can affect any segment of the aorta, from the aortic root to the aortic bifurcation. Juxtarenal Aortic Aneurysms (JAA) (where a specialty designed custom -made device (endograft)which has holes, or fenestrations ,on the graft body to maintain the patency of the visceral arteries) account for approximately 15% of abdominal aortic aneurysms.2
Successful aortic aneurysm treatment depends on either open replacement or endovascular exclusion of the aneurysmal segment with healthy artery proximal and distal to the repair.
The decision to treat an AAA is based on the associated risk of treatment, the risk of aneurysm rupture, the patient's life expectancy, and patient preference.
The primary determinant of rupture risk is maximum aneurysm diameter, with negligible rupture risk in aneurysms <4cm in diameter compared with aneurysms >8 cm . 3, 4.
The Society for Vascular Surgery recommends repair for all patients of acceptable perioperative risk with an AAA ≥5.5 cm in diameter as well as all patients with saccular and symptomatic aneurysms.5 ,6
These guidelines also suggest repair for women at a diameter of 5.0 cm.
Fenestrated Endovascular Aneurysm Repair (FEVAR) and Chimney Endovascular Aneurysm Repair (CHEVAR)are both effective methods to treat JAAs
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cross sectional study
| Arm | Type | Receives |
|---|---|---|
| We compare different endovascular techniques as an alternative | Other | Procedure: Endovascular Repair of Juxtarenal Aortic AneurysmWe compare different endovascular techniques as an alternative to surgical reconstruction to repair JAAS regarding ; success rates, 30-day mortality, endoleak events secondary intervention rates |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Subject is ≥18 years old
Key exclusion criteria (10 listed)
- Subject is participating in a concurrent study which may confound study results
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 |
|---|---|---|
| Endovascular Repair of Juxtarenal Aortic Aneurysm1. History taking and clinical examination. 2. Preoperative Imaging CTA is the cross-sectional imaging modality of choice. 3. Preoperative evaluation a-Renal evaluation b_ cardiac evaluation C-Pulmonary evaluation 4. Surgical techniques 1. Anesthesia The use of general anesthesia due to the duration of the procedures and the necessity to control patient breathing to allow precise imaging and accurate device deployment. 2. Intra operative imaging A "hybrid" operating room with high-quality fixed imaging is needed for the performance of FEVAR. C-Device delivery and deployment all FEVAR procedures begin with access of the femoral arteries by either open or percutaneous technique. | Procedure or surgery | We compare different endovascular techniques as an alternative |
Primary outcome
The primary outcome measure will be clinical success .
Time frame: One year
Clinical success will be evaluated by Measurment of blood pressure by sphygmomanometer in mmhg Serum creatinine level in mg/dL
One year patency of the endovascular graft
Time frame: One year
One year patency will be assessed by CT angiography ( if it is patent or not). CT angiography can detect successful deployment of the endovascular device at the intended location or post endograft complications as type I or III endoleak , graft thrombosis, aneurysm expansion , aneurysm rupture.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Background: PubMed 8024454Taylor SM, Mills JL, Fujitani RM. The juxtarenal abdominal aortic aneurysm. A more common problem than previously realized? Arch Surg. 1994 Jul;129(7):734-7. doi: 10.1001/archsurg.1994.01420310066011.
- Background: PubMed 10493476Brown LC, Powell JT. Risk factors for aneurysm rupture in patients kept under ultrasound surveillance. UK Small Aneurysm Trial Participants. Ann Surg. 1999 Sep;230(3):289-96; discussion 296-7. doi: 10.1097/00000658-199909000-00002.
- Background: PubMed 29268916Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2. doi: 10.1016/j.jvs.2017.10.044.
- Background: PubMed 21215940Moll FL, Powell JT, Fraedrich G, Verzini F, Haulon S, Waltham M, van Herwaarden JA, Holt PJ, van Keulen JW, Rantner B, Schlosser FJ, Setacci F, Ricco JB; European Society for Vascular Surgery. Management of abdominal aortic aneurysms clinical practice guidelines of the European society for vascular surgery. Eur J Vasc Endovasc Surg. 2011 Jan;41 Suppl 1:S1-S58. doi: 10.1016/j.ejvs.2010.09.011. No abstract available.
- Background: PubMed 21092788Greenberg R, Eagleton M, Mastracci T. Branched endografts for thoracoabdominal aneurysms. J Thorac Cardiovasc Surg. 2010 Dec;140(6 Suppl):S171-8. doi: 10.1016/j.jtcvs.2010.07.061.
- Background: PubMed 26898979Coselli JS, LeMaire SA, Preventza O, de la Cruz KI, Cooley DA, Price MD, Stolz AP, Green SY, Arredondo CN, Rosengart TK. Outcomes of 3309 thoracoabdominal aortic aneurysm repairs. J Thorac Cardiovasc Surg. 2016 May;151(5):1323-37. doi: 10.1016/j.jtcvs.2015.12.050. Epub 2016 Jan 14.
- Background: PubMed 26792544Eagleton MJ, Follansbee M, Wolski K, Mastracci T, Kuramochi Y. Fenestrated and branched endovascular aneurysm repair outcomes for type II and III thoracoabdominal aortic aneurysms. J Vasc Surg. 2016 Apr;63(4):930-42. doi: 10.1016/j.jvs.2015.10.095. Epub 2016 Jan 11.
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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.
Ashraf G Taha, MD study director
Assistant professur Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Repair of Juxtarenal Aortic Aneurysm in people with Juxtarenal Aortic Aneurysm, run by Assiut University.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khaled M Awad, Master (01006797162, k.awad5@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure will be clinical success . (time frame: One year). 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?
On the ClinicalTrials.gov record for NCT04252079, which also lists 7 linked publications.
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 5 Feb 2020.