Aortoiliac Occlusive DiseaseNCT04148456
CERAB Technique for Aortoiliac Occlusive Disease
A study testing Covered Endovacular Reconstruction of Aortic Bifurcation in people with Aortoiliac Occlusive Disease, run by Assiut University.
Trial summary
To evaluate the safety and efficacy of the CERAB technique as an alternative to surgical reconstruction for treatment of aorto-iliac occlusive disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortoiliac Occlusive Disease
- What is being tested?
- Covered Endovacular Reconstruction of Aortic Bifurcation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 1 Jan 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 years and older patients.
- Patient presented with disabling claudication pain.
- Patient presented with rest pain.
- Patient presented with gangrene or atrophic changes.
- Provided written informed consent.
- Eligible anatomy for CERAB technique.
- TASC- (II) classification as assigned in the study protocol (specified type B, C and D lesions).
Who cannot join
- Age less than 18 years old.
- Patients with acute limb ischemia.
- Patients treated with open surgery and other endovascular techniques such as kissing stenting.
- CERAB configuration extending into aneurysmatic infrarenal aorta.
- Patient's life expectancy <2 years as judged by the investigator.
- Patient has a psychiatric or other condition that may interfere with the study.
Show all 11Show fewer
- Patient has a known allergy to any device component.
- Patients with a systemic infection who may be at increased risk of endovascular graft infection.
- Patient has a coagulopathy or uncontrolled bleeding disorder.
- Patient had a recent cerebrovascular accident (CVA) or a myocardial infarction (MI) within the prior three months.
- Patient is pregnant (Female patients of childbearing potential only).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) Technique for Extensive Aortoiliac Occlusive Disease
To evaluate the safety and efficacy of the CERAB technique as an alternative to surgical reconstruction for treatment of aorto-iliac occlusive disease.
Read the detailed description
According to the Trans-Atlantic Inter-society Consensus (TASC-II), bypass grafting is the treatment of choice for extensive aortoiliac occlusive disease (AIOD) due to the good long-term patency rates. However, surgical reconstruction is associated with peri-operative morbidity and mortality.
Kissing stent technique was introduced as an endovascular treatment alternative for bilateral aortoiliac occlusive disease in 1991. Reported technical success rates varied with the use of bare metal stents in extensive AOID.
The COBEST trial showed that covered balloon expandable stents (CBES) have a superior primary patency rate and clinical improvement outcome at 24 months when compared with bare metal stents. CBES may immediately reduce the risk of procedural complications such as dissection, perforation, in-stent stenosis, and embolization.
In 2013, CERAB technique was introduced to improve endovascular treatment results by a more anatomical and physiological reconstruction, with a subsequent better clinical outcome.
The CERAB technique was developed to overcome the anatomical and physiological disadvantages of kissing stents such as flow disturbances leading to turbulence and stasis of blood, which may cause thrombus formation and intimal neohyperplasia.
The early results of the CERAB configuration are promising at 1-year follow up in a group of 130 patients with AOID and the 30-day major complication rate was 7.7%.
CERAB and Chimney CERAB (C-CERAB) techniques may change the treatment algorithm of AIOD and juxta-renal occlusive disease. It appears to be a safe and feasible alternative with promising results, being a valid alternative for surgery and/or kissing stents.
- Conditions
- Aortoiliac Occlusive Disease
- Being tested
- Covered Endovacular Reconstruction of Aortic Bifurcation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covered Endovacular Reconstruction of Aortic BifurcationProcedure or surgery
- The occlusive lesion is then passed, either subintimal or endoluminal, using crossing wires and catheters.
- After gaining re-entry into the lumen of the aorta, angiography will be confirmed proper positioning for those with a subintimal passage.
- A 10-12 mm V12 LD balloon expandable ePTFE covered stent (Atrium Medical, Maquet Getinge Group, Hudson, NH) will be expanded in the distal aorta approximately 20 mm above the bifurcation through the 9 Fr sheath.
- The proximal 2/3 part of the aortic stent will be flared with a larger balloon, usually 16 mm, thereby creating a funnel shaped covered stent. Subsequently, two 8 mm V12 balloon expandable ePTFE covered stents (Atrium Medical, Maquet Getinge Group, Hudson, NH) will be placed proximally in the distal 1/3 of the aortic stent, and then simultaneously deployed distally into the common iliac arteries creating a tight connection with the first aortic stent, thereby creating the new aortic bifurcation.
| Study group | Role | What they receive |
|---|---|---|
| Aortoiliac occlusive disease | Other | This study will be carried out on patients with extensive Aortoiliac occlusive disease using the CERAB technique. Receives: Procedure: Covered Endovacular Reconstruction of Aortic Bifurcation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency
uninterrupted patency in the absence of re-stenosis or occlusion, without any procedures performed on the vessel or stent.
Measured: 12 months
Technical success
successful implantation of the CERAB device restoring blood flow with <30% residual stenosis without conversion to open repair during the 30-days after implantation
Measured: 1 month
Secondary outcomes (6)
Secondary patency
patency achieved by all procedures aimed at recanalizing an occluded CBES, thereby preserving the endograft.
Measured: 12 months
Freedom from target lesion revascularization (TLR)
an open endograft without procedures performed for re-stenosis or occlusion leading to symptoms requiring an intervention.
Measured: 12 months
Clinical improvement
hemodynamic improvement with an increase of at least 0.10 in ABI, combined with a symptomatic improvement of at least one Rutherford category.
Measured: 12 months
Re-stenosis
a lesion with a peak systolic value (PSV) ratio >2.5 as measured in the endograft and proximal or distal to the endograft or an angiographic diameter reduction of >50%.
Measured: 12 months
Limb salvage rate
all patients without above ankle amputations
Measured: 12 months
Minor complications
those that were only temporary leading to impairment, whereas major complications were defined by permanent damage or death.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start1 Jan 2021 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Aortoiliac Occlusive DiseaseStudies 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
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mohamed Abd Elhakam Abd Elbaqi, Assiut University
- Investigators
- omar M Abd Elhakam, Doctor, Principal investigator, Assiut UniversityAyman E Hassaballah, Professor, Study director, Assiut UniversityHaitham A Hassan, Doctor, Study chair, Assiut UniversityAhmed K Sayed, Doctor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148456
- Sponsor's protocol ID
- CERAB for AIOD
- Status last verified
- Jul 2020
- First submitted
- 30 Oct 2019
- Last updated
- 13 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007 Jan;45 Suppl S:S5-67. doi: 10.1016/j.jvs.2006.12.037. No abstract available.
PubMed 17223489Kuffer G, Spengel F, Steckmeier B. Percutaneous reconstruction of the aortic bifurcation with Palmaz stents: case report. Cardiovasc Intervent Radiol. 1991 May-Jun;14(3):170-2. doi: 10.1007/BF02577722. No abstract available.
PubMed 1878908Grimme FA, Goverde PA, Van Oostayen JA, Zeebregts CJ, Reijnen MM. Covered stents for aortoiliac reconstruction of chronic occlusive lesions. J Cardiovasc Surg (Torino). 2012 Jun;53(3):279-89.
PubMed 22695260Bosiers M, Iyer V, Deloose K, Verbist J, Peeters P. Flemish experience using the Advanta V12 stent-graft for the treatment of iliac artery occlusive disease. J Cardiovasc Surg (Torino). 2007 Feb;48(1):7-12.
PubMed 17308516Grimme FA, Spithoven JH, Zeebregts CJ, Scharn DM, Reijnen MM. Midterm outcome of balloon-expandable polytetrafluoroethylene-covered stents in the treatment of iliac artery chronic occlusive disease. J Endovasc Ther. 2012 Dec;19(6):797-804. doi: 10.1583/JEVT-12-3941MR.1.
PubMed 23210879Grimme FA, Reijnen MM, Pfister K, Martens JM, Kasprzak P. Polytetrafluoroethylene covered stent placement for focal occlusive disease of the infrarenal aorta. Eur J Vasc Endovasc Surg. 2014 Nov;48(5):545-50. doi: 10.1016/j.ejvs.2014.08.009. Epub 2014 Sep 11.
PubMed 25218651Sabri SS, Choudhri A, Orgera G, Arslan B, Turba UC, Harthun NL, Hagspiel KD, Matsumoto AH, Angle JF. Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation. J Vasc Interv Radiol. 2010 Jul;21(7):995-1003. doi: 10.1016/j.jvir.2010.02.032. Epub 2010 Jun 11.
PubMed 20538478Palmaz JC, Encarnacion CE, Garcia OJ, Schatz RA, Rivera FJ, Laborde JC, Dougherty SP. Aortic bifurcation stenosis: treatment with intravascular stents. J Vasc Interv Radiol. 1991 Aug;2(3):319-23. doi: 10.1016/s1051-0443(91)72250-1.
PubMed 1839237Mwipatayi BP, Thomas S, Wong J, Temple SE, Vijayan V, Jackson M, Burrows SA; Covered Versus Balloon Expandable Stent Trial (COBEST) Co-investigators. A comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease. J Vasc Surg. 2011 Dec;54(6):1561-70. doi: 10.1016/j.jvs.2011.06.097. Epub 2011 Sep 9.
PubMed 21906903Goverde PC, Grimme FA, Verbruggen PJ, Reijnen MM. Covered endovascular reconstruction of aortic bifurcation (CERAB) technique: a new approach in treating extensive aortoiliac occlusive disease. J Cardiovasc Surg (Torino). 2013 Jun;54(3):383-7.
PubMed 23640357Saker MB, Oppat WF, Kent SA, Ryu RK, Chrisman HB, Nemcek AA, Pearce W, Pearce W, Vogelzang R. Early failure of aortoiliac kissing stents: histopathologic correlation. J Vasc Interv Radiol. 2000 Mar;11(3):333-6. doi: 10.1016/s1051-0443(07)61426-2. No abstract available.
PubMed 10735428Taeymans K, Goverde P, Lauwers K, Verbruggen P. The CERAB technique: tips, tricks and results. J Cardiovasc Surg (Torino). 2016 Jun;57(3):343-9. Epub 2016 Mar 24.
PubMed 27012930Groot Jebbink E, Grimme FA, Goverde PC, van Oostayen JA, Slump CH, Reijnen MM. Geometrical consequences of kissing stents and the Covered Endovascular Reconstruction of the Aortic Bifurcation configuration in an in vitro model for endovascular reconstruction of aortic bifurcation. J Vasc Surg. 2015 May;61(5):1306-11. doi: 10.1016/j.jvs.2013.12.026. Epub 2014 Jan 29.
PubMed 24486037Grimme FA, Goverde PC, Verbruggen PJ, Zeebregts CJ, Reijnen MM. Editor's Choice--First Results of the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique for Aortoiliac Occlusive Disease. Eur J Vasc Endovasc Surg. 2015 Nov;50(5):638-47. doi: 10.1016/j.ejvs.2015.06.112. Epub 2015 Sep 3.
PubMed 26343310Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997 Sep;26(3):517-38. doi: 10.1016/s0741-5214(97)70045-4.
PubMed 9308598
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) Technique for Extensive Aortoiliac Occlusive Disease
- ClinicalTrials.gov ID
- NCT04148456
- Acronym / sponsor ID
- CERAB for AIOD
- Conditions
- Aortoiliac Occlusive Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 1 Nov 2019 (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.
To evaluate the safety and efficacy of the CERAB technique as an alternative to surgical reconstruction for treatment of aorto-iliac occlusive disease.
Detailed description
According to the Trans-Atlantic Inter-society Consensus (TASC-II), bypass grafting is the treatment of choice for extensive aortoiliac occlusive disease (AIOD) due to the good long-term patency rates. However, surgical reconstruction is associated with peri-operative morbidity and mortality.
Kissing stent technique was introduced as an endovascular treatment alternative for bilateral aortoiliac occlusive disease in 1991. Reported technical success rates varied with the use of bare metal stents in extensive AOID.
The COBEST trial showed that covered balloon expandable stents (CBES) have a superior primary patency rate and clinical improvement outcome at 24 months when compared with bare metal stents. CBES may immediately reduce the risk of procedural complications such as dissection, perforation, in-stent stenosis, and embolization.
In 2013, CERAB technique was introduced to improve endovascular treatment results by a more anatomical and physiological reconstruction, with a subsequent better clinical outcome.
The CERAB technique was developed to overcome the anatomical and physiological disadvantages of kissing stents such as flow disturbances leading to turbulence and stasis of blood, which may cause thrombus formation and intimal neohyperplasia.
The early results of the CERAB configuration are promising at 1-year follow up in a group of 130 patients with AOID and the 30-day major complication rate was 7.7%.
CERAB and Chimney CERAB (C-CERAB) techniques may change the treatment algorithm of AIOD and juxta-renal occlusive disease. It appears to be a safe and feasible alternative with promising results, being a valid alternative for surgery and/or kissing stents.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortoiliac occlusive disease | Other | Procedure: Covered Endovacular Reconstruction of Aortic BifurcationThis study will be carried out on patients with extensive Aortoiliac occlusive disease using the CERAB technique. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18 years and older patients.
- Patient presented with disabling claudication pain.
- Patient presented with rest pain.
- Patient presented with gangrene or atrophic changes.
- Provided written informed consent.
Key exclusion criteria (11 listed)
- Age less than 18 years old.
- Patients with acute limb ischemia.
- Patients treated with open surgery and other endovascular techniques such as kissing stenting.
- CERAB configuration extending into aneurysmatic infrarenal aorta.
- Patient's life expectancy <2 years as judged by the investigator.
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 |
|---|---|---|
| Covered Endovacular Reconstruction of Aortic Bifurcation* The occlusive lesion is then passed, either subintimal or endoluminal, using crossing wires and catheters. * After gaining re-entry into the lumen of the aorta, angiography will be confirmed proper positioning for those with a subintimal passage. * A 10-12 mm V12 LD balloon expandable ePTFE covered stent (Atrium Medical, Maquet Getinge Group, Hudson, NH) will be expanded in the distal aorta approximately 20 mm above the bifurcation through the 9 Fr sheath. * The proximal 2/3 part of the aortic stent will be flared with a larger balloon, usually 16 mm, thereby creating a funnel shaped covered stent. Subsequently, two 8 mm V12 balloon expandable ePTFE covered stents (Atrium Medical, Maquet Getinge Group, Hudson, NH) will be placed proximally in the distal 1/3 of the aortic stent, and then simultaneously deployed distally into the common iliac arteries creating a tight connection with the first aortic stent, thereby creating the new aortic bifurcation. | Procedure or surgery | Aortoiliac occlusive disease |
Primary outcome
Primary patency
Time frame: 12 months
uninterrupted patency in the absence of re-stenosis or occlusion, without any procedures performed on the vessel or stent.
Technical success
Time frame: 1 month
successful implantation of the CERAB device restoring blood flow with <30% residual stenosis without conversion to open repair during the 30-days after implantation
6 secondary outcomes
Secondary patency
Time frame: 12 months
Freedom from target lesion revascularization (TLR)
Time frame: 12 months
Clinical improvement
Time frame: 12 months
Re-stenosis
Time frame: 12 months
Limb salvage rate
Time frame: 12 months
Minor complications
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Background: PubMed 17223489Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007 Jan;45 Suppl S:S5-67. doi: 10.1016/j.jvs.2006.12.037. No abstract available.
- Background: PubMed 1878908Kuffer G, Spengel F, Steckmeier B. Percutaneous reconstruction of the aortic bifurcation with Palmaz stents: case report. Cardiovasc Intervent Radiol. 1991 May-Jun;14(3):170-2. doi: 10.1007/BF02577722. No abstract available.
- Background: PubMed 22695260Grimme FA, Goverde PA, Van Oostayen JA, Zeebregts CJ, Reijnen MM. Covered stents for aortoiliac reconstruction of chronic occlusive lesions. J Cardiovasc Surg (Torino). 2012 Jun;53(3):279-89.
- Background: PubMed 17308516Bosiers M, Iyer V, Deloose K, Verbist J, Peeters P. Flemish experience using the Advanta V12 stent-graft for the treatment of iliac artery occlusive disease. J Cardiovasc Surg (Torino). 2007 Feb;48(1):7-12.
- Background: PubMed 23210879Grimme FA, Spithoven JH, Zeebregts CJ, Scharn DM, Reijnen MM. Midterm outcome of balloon-expandable polytetrafluoroethylene-covered stents in the treatment of iliac artery chronic occlusive disease. J Endovasc Ther. 2012 Dec;19(6):797-804. doi: 10.1583/JEVT-12-3941MR.1.
- Background: PubMed 25218651Grimme FA, Reijnen MM, Pfister K, Martens JM, Kasprzak P. Polytetrafluoroethylene covered stent placement for focal occlusive disease of the infrarenal aorta. Eur J Vasc Endovasc Surg. 2014 Nov;48(5):545-50. doi: 10.1016/j.ejvs.2014.08.009. Epub 2014 Sep 11.
- Background: PubMed 20538478Sabri SS, Choudhri A, Orgera G, Arslan B, Turba UC, Harthun NL, Hagspiel KD, Matsumoto AH, Angle JF. Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation. J Vasc Interv Radiol. 2010 Jul;21(7):995-1003. doi: 10.1016/j.jvir.2010.02.032. Epub 2010 Jun 11.
- Background: PubMed 1839237Palmaz JC, Encarnacion CE, Garcia OJ, Schatz RA, Rivera FJ, Laborde JC, Dougherty SP. Aortic bifurcation stenosis: treatment with intravascular stents. J Vasc Interv Radiol. 1991 Aug;2(3):319-23. doi: 10.1016/s1051-0443(91)72250-1.
- Background: PubMed 21906903Mwipatayi BP, Thomas S, Wong J, Temple SE, Vijayan V, Jackson M, Burrows SA; Covered Versus Balloon Expandable Stent Trial (COBEST) Co-investigators. A comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease. J Vasc Surg. 2011 Dec;54(6):1561-70. doi: 10.1016/j.jvs.2011.06.097. Epub 2011 Sep 9.
- Background: PubMed 23640357Goverde PC, Grimme FA, Verbruggen PJ, Reijnen MM. Covered endovascular reconstruction of aortic bifurcation (CERAB) technique: a new approach in treating extensive aortoiliac occlusive disease. J Cardiovasc Surg (Torino). 2013 Jun;54(3):383-7.
- Background: PubMed 10735428Saker MB, Oppat WF, Kent SA, Ryu RK, Chrisman HB, Nemcek AA, Pearce W, Pearce W, Vogelzang R. Early failure of aortoiliac kissing stents: histopathologic correlation. J Vasc Interv Radiol. 2000 Mar;11(3):333-6. doi: 10.1016/s1051-0443(07)61426-2. No abstract available.
- Background: PubMed 27012930Taeymans K, Goverde P, Lauwers K, Verbruggen P. The CERAB technique: tips, tricks and results. J Cardiovasc Surg (Torino). 2016 Jun;57(3):343-9. Epub 2016 Mar 24.
Related trials for Aortoiliac Occlusive Disease
RecruitingObservational study
Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease
Aortoiliac Occlusive Disease
RecruitingObservational study
Predictors of Major Adverse Limb Events After Endovascular Iliac Stenting: a Real-world Cohort Study
Peripheral Arterial Disease, Aortoiliac Occlusive Disease
RecruitingObservational study
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)
Aorto-iliac Occlusive Disease (AIOD), Visceral Artery Occlusive Disease (VAOD)
Recruiting
The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease
Aortoiliac Occlusive Disease, Peripheral Arterial Disease
RecruitingPhase 4
Liposomal Bupivacaine/Bupivacaine in Rectus Sheath Blocks Versus Ropivacaine in Rectus Sheath Blocks And Catheters
Aortic Aneurysm, Abdominal, Abdominal Aortic Occlusion
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.
omar M Abd Elhakam, Doctor principal investigator
Assiut University
Ayman E Hassaballah, Professor study director
Assiut University
Haitham A Hassan, Doctor study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Covered Endovacular Reconstruction of Aortic Bifurcation in people with Aortoiliac Occlusive Disease, 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 7 inclusion and 11 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 13 Jul 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 omar M Abd Elhakam, Doctor (01064991946, omarhejazy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency (time frame: 12 months). 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 NCT04148456, which also lists 15 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 13 Jul 2020.