CERAB Technique for Aortoiliac Occlusive Disease

NCT04148456 | Unknown

• 1 other identifier: CERAB for AIOD
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the safety and efficacy of the CERAB technique as an alternative to surgical reconstruction for treatment of aorto-iliac occlusive disease.

Conditions

Aortoiliac Occlusive Disease

Outcome Measures

Primary Outcomes (2)

• Primary patency

  uninterrupted patency in the absence of re-stenosis or occlusion, without any procedures performed on the vessel or stent.

  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

  1 month

Secondary Outcomes (6)

• Secondary patency

  12 months

• Freedom from target lesion revascularization (TLR)

  12 months

• Clinical improvement

  12 months

• Re-stenosis

  12 months

• Limb salvage rate

  12 months

Study Arms (1)

Aortoiliac occlusive disease

OTHER

This study will be carried out on patients with extensive Aortoiliac occlusive disease using the CERAB technique.

Procedure: Covered Endovacular Reconstruction of Aortic Bifurcation

Interventions

Covered Endovacular Reconstruction of Aortic Bifurcation PROCEDURE

* 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.

Aortoiliac occlusive disease

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (15)

• 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.

  PMID: 17223489 BACKGROUND

• Kuffer 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.

  PMID: 1878908 BACKGROUND

• Grimme 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.

  PMID: 22695260 BACKGROUND

• Bosiers 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.

  PMID: 17308516 BACKGROUND

• Grimme 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.

  PMID: 23210879 BACKGROUND

• Grimme 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.

  PMID: 25218651 BACKGROUND

• Sabri 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.

  PMID: 20538478 BACKGROUND

• Palmaz 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.

  PMID: 1839237 BACKGROUND

• Mwipatayi 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.

  PMID: 21906903 BACKGROUND

• Goverde 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.

  PMID: 23640357 BACKGROUND

• Saker 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.

  PMID: 10735428 BACKGROUND

• Taeymans 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.

  PMID: 27012930 BACKGROUND

• Groot 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.

  PMID: 24486037 BACKGROUND

• Grimme 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.

  PMID: 26343310 BACKGROUND

• Rutherford 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.

  PMID: 9308598 BACKGROUND

Study Officials

• omar M Abd Elhakam, Doctor

  Assiut University

  PRINCIPAL INVESTIGATOR

• Ayman E Hassaballah, Professor

  Assiut University

  STUDY DIRECTOR

• Haitham A Hassan, Doctor

  Assiut University

  STUDY CHAIR

• Ahmed K Sayed, Doctor

  Assiut University

  STUDY CHAIR

Central Study Contacts

omar M Abd Elhakam, Doctor

CONTACT

01064991946; omarhejazy@ymail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: January 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: July 13, 2020

Record last verified: 2020-07