Clinical trial NCT04148456: CERAB Technique for Aortoiliac Occlusive Disease
Official title: Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) Technique for Extensive Aortoiliac Occlusive Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortoiliac Occlusive Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age: 18 years and older patients.
2. Patient presented with disabling claudication pain.
3. Patient presented with rest pain.
4. Patient presented with gangrene or atrophic changes.
5. Provided written informed consent.
6. Eligible anatomy for CERAB technique.
7. TASC- (II) classification as assigned in the study protocol (specified type B, C and D lesions).

Exclusion Criteria:

1. Age less than 18 years old.
2. Patients with acute limb ischemia.
3. Patients treated with open surgery and other endovascular techniques such as kissing stenting.
4. CERAB configuration extending into aneurysmatic infrarenal aorta.
5. Patient's life expectancy \<2 years as judged by the investigator.
6. Patient has a psychiatric or other condition that may interfere with the study.
7. Patient has a known allergy to any device component.
8. Patients with a systemic infection who may be at increased risk of endovascular graft infection.
9. Patient has a coagulopathy or uncontrolled bleeding disorder.
10. Patient had a recent cerebrovascular accident (CVA) or a myocardial infarction (MI) within the prior three months.
11. Patient is pregnant (Female patients of childbearing potential only).

Primary outcomes:
measure: Primary patency
timeFrame: 12 months
measure: Technical success
timeFrame: 1 month
Secondary outcomes:
measure: Secondary patency
timeFrame: 12 months
measure: Freedom from target lesion revascularization (TLR)
timeFrame: 12 months
measure: Clinical improvement
timeFrame: 12 months
measure: Re-stenosis
timeFrame: 12 months
measure: Limb salvage rate
timeFrame: 12 months
measure: Minor complications
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: omar M Abd Elhakam, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Ayman E Hassaballah, Professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Haitham A Hassan, Doctor
role: STUDY_CHAIR
affiliation: Assiut University
name: Ahmed K Sayed, Doctor
role: STUDY_CHAIR
References:
citation: 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.
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