Overview

This trial is active, not recruiting.

Conditions aortic aneurysm, abdominal, blood vessel prosthesis implantation
Treatments evar (endovascular repair of abdominal aortic aneurysm), surveillance
Phase phase 4
Sponsor University Of Perugia
Collaborator William Cook Europe
Start date September 2004
End date May 2010
Trial size 360 participants
Trial identifier NCT00118573, 384/03

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
AAA repair with endografting
evar (endovascular repair of abdominal aortic aneurysm) early endovascular repair of abdominal aortic aneurysm
AAA repair with endografting
(Active Comparator)
Not AAA repair; surveillance
surveillance monitoring abdominal aortic aneurysm without repair
Surveillance of AAA without any repair until AAA will reach 5.5cm, become tender or rapidly grow

Primary Outcomes

Measure
all cause mortality at 3 years
time frame: 3 years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 50 years up to 80 years old.

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

Additional Information

Official title Randomized Clinical Trial Comparing Surveillance and Selective Surgical Treatment for Abdominal Aortic Aneurysms Less Than 5.5 cm in Diameter Versus Early Endovascular Treatment
Principal investigator Piergiorgio Cao, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by University Of Perugia.