Comparison of Surveillance Versus Aortic Endografting for... | NCT00118573

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lower than anticipated events;slow recruitment;larger than predicted sample size

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

May 2010Actual

Completion Date

Sep 2017Estimated

First Submitted Date

Jun 30, 2005

First Submission Date that Met QC Criteria

Jun 30, 2005

First Posted Date

Jul 11, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2015

Last Update Posted Date

Dec 10, 2015Estimated

Name	Class
William Cook Europe	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

360Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EVAR	Experimental	AAA repair with endografting	Procedure: EVAR (Endovascular repair of Abdominal Aortic aneurysm)
Surveillance	Active Comparator	Not AAA repair; surveillance	Procedure: Surveillance

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EVAR (Endovascular repair of Abdominal Aortic aneurysm)	Procedure	AAA repair with endografting	EVAR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all cause mortality at 3 years		3 years

Secondary Outcomes

Measure	Description	Time Frame
aneurysm related mortality at 3 years		3 years
aneurysm rupture rates at 3 years		3 years
perioperative or late complications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Piergiorgio Cao, MD	University Of Perugia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vitkovice Hospital Ostrava and University Hospital Ostrava - Poruba		Ostrava			Czechia
Hopital Cardiologique CHRU

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8696960	Background	Alcorn HG, Wolfson SK Jr, Sutton-Tyrrell K, Kuller LH, O'Leary D. Risk factors for abdominal aortic aneurysms in older adults enrolled in The Cardiovascular Health Study. Arterioscler Thromb Vasc Biol. 1996 Aug;16(8):963-70. doi: 10.1161/01.atv.16.8.963.
7901685	Background	Scott RA, Wilson NM, Ashton HA, Kay DN. Is surgery necessary for abdominal aortic aneurysm less than 6 cm in diameter? Lancet. 1993 Dec 4;342(8884):1395-6. doi: 10.1016/0140-6736(93)92756-j.

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001018	Aortic Diseases

ID	Term
D012038	Regeneration
D001686	Biological Phenomena