COvered Balloon Expandable Stent Trial
| ISRCTN | ISRCTN89458845 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89458845 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/01/2006
- Registration date
- 28/02/2006
- Last edited
- 06/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Bibombe Patrice Mwipatayi
Scientific
Scientific
Vascular Unit
Royal Perth Hospital
Wellington street
Perth
6000
Australia
Study information
| 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 |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | COvered Balloon Expandable Stent Trial |
| Study acronym | COBEST |
| Study objectives | Does covered stent in aortoiliac occlusive disease have the same patency or even better patency rate than bared stent? |
| Ethics approval(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 20/02/2006 |
| Completion date | 30/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 154 |
| Total final enrolment | 125 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 20/02/2006 |
| Date of final enrolment | 30/08/2007 |
Locations
Countries of recruitment
- Australia
Study participating centre
Vascular Unit
Perth
6000
Australia
6000
Australia
Sponsor information
Atrium Australia (Australia)
Industry
Industry
Julia Agars
Atrium Australia
PO Box 420
Spit junction
New South Wales
2088
Australia
| Website | http://www.atriummed.com |
|---|---|
"ROR" |
https://ror.org/03ds2he10 |
Funders
Funder type
Industry
Atrium Australia (Australia)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 09/09/2011 | 06/08/2021 | Yes | No |
Editorial Notes
06/08/2021: Publication reference and total final enrolment added.
