Condition category
Circulatory System
Date applied
26/01/2006
Date assigned
28/02/2006
Last edited
21/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Bibombe Patrice Mwipatayi

ORCID ID

Contact details

Vascular Unit
Royal Perth Hospital
Wellington street
Perth
6000
Australia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

COBEST

Study hypothesis

Does covered stent in aortoiliac occlusive disease have the same patency or even better patency rate than bared stent?

Ethics approval

Ethical approval received from the following hospitals:
1. Royal Perth Hospital (Australia)
2. St Vincent’s Public Hospital (Australia)

The following hospitals are pending ethical approval for participation in the COBEST trial:
St Vincent’s Private Hospital (Australia)
Royal Prince Alfred Hospital (Australia)
Hollywood Private Hospital (Australia)

Study design

The study is an interventional, prospective, multicentre, randomised, controlled non-inferiority trial of V12 covered stent versus bare stent.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Iliac artery occlusive disease

Intervention

V12 covered stent versus bare stents.

Runoff vessels:
The superficial and deep femoral arteries are the runoff vessels for iliac artery procedures, and the tibial arteries are the runoff vessels for femoral or popliteal procedures. The scoring system below will be used:
1. Two points will be given to a widely patent Superficial Femoral Artery (SFA) or Profunda femoris (2)
2. One point for a diseased but patent vessel (SFA or profunda femoris) (1)
3. No points for an occluded vessel (SFA or profunda femoris) (0)
Thus giving a range from zero to four, where four represents an excellent run-off.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Comparison, between the two treatment groups (V12 covered stent versus bare stents) of:
1. Primary patency
2. Assisted primary patency

Secondary outcome measures

Secondary objectives:
1. Any amputation above the ankle
2. Ankle Brachial Index (ABI) changes from baseline

Overall trial start date

20/02/2006

Overall trial end date

30/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Informed consent obtained
2. Patient aged 18 years or over and under 80 years
3. Patients with TransAtlantic Society Consensus (TASC) type B, C and D lesions
4. Haemodynamically significant dissections after angioplasty
5. Haemodynamically significant recurrent stenosis after angioplasty

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

154

Participant exclusion criteria

1. Life expectancy of less than 12 months
2. Patients with uncontrolled hypertension
3. Patient with TASC type A lesion
4. Pregnant women or women of childbearing potential who are not following an effective method of contraception
5. Prior enrolment in this trial, patients who had any procedure performed at the aortoiliac level
6. Patients with extensive common femoral artery disease or who have had multiple groin procedures
7. Contradiction to aspirin or clopidogrel usage
8. Patients with superficial and profunda femoral arteries occluded
9. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study, or language barrier such that the subject being unable to give informed consent
10. Uncooperative attitude or potential for non-compliance with the requirements of the protocol making study participation impractical

N.B. In patients with a plasma/serum creatinine of more than 250 - 300 µmol/L, iodinated contrast is contraindicated and should be avoided.

Recruitment start date

20/02/2006

Recruitment end date

30/08/2007

Locations

Countries of recruitment

Australia

Trial participating centre

Vascular Unit
Perth
6000
Australia

Sponsor information

Organisation

Atrium Australia (Australia)

Sponsor details

Julia Agars
Atrium Australia
PO Box 420
Spit junction
New South Wales
2088
Australia

Sponsor type

Industry

Website

http://www.atriummed.com

Funders

Funder type

Industry

Funder name

Atrium Australia (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes