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 Vincents Public Hospital (Australia)
The following hospitals are pending ethical approval for participation in the COBEST trial:
St Vincents 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
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