Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair

Phase 4TerminatedNCT00118573

University Of Perugia360 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

360

Conditions

Aortic Aneurysm, Abdominal Endovascular

Interventions

EVAR (Endovascular repair of Abdominal Aortic aneurysm)PROCEDURE

AAA repair with endografting

SurveillancePROCEDURE

Surveillance of AAA without any repair until AAA will reach 5.5cm, become tender or rapidly grow

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (20)

Vitkovice Hospital Ostrava and University Hospital Ostrava - Poruba

Ostrava, Czechia

Hopital Cardiologique CHRU

Lille, France

Outcomes

Primary Outcomes

all cause mortality at 3 years

Time frame: 3 years

Secondary Outcomes

aneurysm related mortality at 3 years

Time frame: 3 years

aneurysm rupture rates at 3 years

Time frame: 3 years

perioperative or late complications

Time frame: 30 days and 3 years

conversion to open repair

Time frame: 30 days and 3 years

loss of treatment options

Time frame: 3 years

risks associated with delayed treatment

Time frame: 30 days and 3 years

aneurysm growth rates

Time frame: 3 years

quality of life

Time frame: 30 days, 6 month, 1 year, 3 years

Data from ClinicalTrials.gov

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