Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair

Phase 4

Terminated

• Conditions: Aortic Aneurysm, Abdominal; Endovascular

• Registration Number: NCT00118573
• Lead Sponsor: University Of Perugia

Brief Summary

Objective of the present study is to compare endovascular repair versus surveillance and, eventually delay treatment in patients with small abdominal aortic aneurysms (AAA), with respect to patient survival, AAA rupture and AAA related death risks.

Detailed Description

The study will include patients with small AAA (diameter 4.1 to 5.4 cm defined by Computed Tomographic scan) suitable for endovascular repair (EVAR).

Randomization is designed with equal probability of assignment to each of the two groups (ie, immediate endovascular repair or surveillance group) by means of a computer-generated -random-number list . After eligibility is verified, assignment will be made using a computer database held at the Coordinating Centre.

In the immediate repair group, endovascular repair with introduction of an aortic endograft (Cook Zenith) will be performed within six weeks from randomization.

In the surveillance group, patients are followed without repair until the aneurysm reaches 5.5 cm in diameter, or enlarges at least 1.0 cm in one year, or until patient develops symptoms that are attributed to the aneurysm by the attending investigator. When one of these criteria is met, endovascular repair (if the patient remains a candidate for EVAR), or open repair will be carried out.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-11
• Primary Completion: 2010-05
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-09
• Last Update Posted: 2015-12-10
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Patients of 50-80 years of age
• Non symptomatic infrarenal AAA of 4.1 to 5.4 cm in diameter measured by CT performed within 3 months before randomization
• Adequate infrarenal aortic neck (length > 15 mm diameter < 30 mm) and other anatomical configurations suitable for EVAR
• Patients have a life expectancy of at least 5 years
• Signed informed consent

Exclusion Criteria

• Ruptured or symptomatic AAA
• AAA maximum diameter >= 5.5 cm
• Suprarenal or thoracic aorta aneurysm of more than 4.0 cm
• Patient unsuitable for administration of contrast agent
• Severe heart, lung, liver or renal disease (serum creatinine >= 3mg/dl)
• Need for adjunctive major surgical or vascular procedures within 1 month
• High likelihood of non compliance with follow-up requirements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
all cause mortality at 3 years	3 years

Secondary Outcome Measures

Name	Time	Method
risks associated with delayed treatment	30 days and 3 years
aneurysm rupture rates at 3 years	3 years
aneurysm growth rates	3 years
quality of life	30 days, 6 month, 1 year, 3 years
aneurysm related mortality at 3 years	3 years
conversion to open repair	30 days and 3 years
perioperative or late complications	30 days and 3 years
loss of treatment options	3 years

Trial Locations

Locations (20)

Vitkovice Hospital Ostrava and University Hospital Ostrava - Poruba; 🇨🇿 Ostrava, Czech Republic

Hopital Cardiologique CHRU; 🇫🇷 Lille, France

University of Koeln; 🇩🇪 Koeln, Germany

Klinik Fuer Gefasschirurgie st.Franziskus Hospital; 🇩🇪 Muenster, Germany

Carmel Medical Center; 🇮🇱 Haifa, Israel

U.O.Chirurgia Vascolare Az Osp Carrara; 🇮🇹 Carrara, Italy

Dip Chirurgia Vascolare Osp S.Anna; 🇮🇹 Ferrara, Italy

Chirurgia Vascolare Az Osp Careggi; 🇮🇹 Firenze, Italy

Chirurgia Vascolare Ospedale San Giovanni di Dio; 🇮🇹 Firenze, Italy

Chirurgia Vascolare, Ospedale San Donato; 🇮🇹 Milano, Italy

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