Safety and efficacy of the Misago® peripheral self-expanding stent system in real-world patients
| ISRCTN | ISRCTN57930977 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57930977 |
| Secondary identifying numbers | T112E2 |
- Submission date
- 21/10/2009
- Registration date
- 30/11/2009
- Last edited
- 12/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Vladimir Borovicanin
Scientific
Scientific
Terumo Europe N.V.
European Medical and Clinical Division
Research Park Zone 2, Haasrode
Interleuvenlaan 40
Leuven
B-3001
Belgium
| Phone | +32 (0)16 38 14 54 |
|---|---|
| vladimir.borovicanin@terumo-europe.com |
Study information
| Study design | Observational non-randomised single-arm prospective multicentre study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Multi-centre |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Prospective, non-randomised, multicentre, observational study to further support safety and efficacy of the Misago® peripheral self-expanding stent system in real-world patients |
| Study acronym | E-MISAGO |
| Study hypothesis | The objective is to further support safety and efficacy of the Misago® peripheral self-expanding stent system in real-world patients. The rationale for this study is to create - on the largest scale ever - a window into the real-world of patients treated with the Misago® Stent (as one of the newest generation nitinol self-expanding stents). |
| Ethics approval(s) | Ethics Committee of UZ Gent (Belgium) approved on 06/08/2009. All other participating countries have submitted to all participating Hospital Ethics Committees wherever such requirement exists prior to enrolment of patients. Last site start up expected April 2010. |
| Condition | Occluded or stenotic iliac, superficial femoral and/or popliteal arteries |
| Intervention | Observational collection of routine hospital practice including clinical/telephone follow-up and monitoring of all serious adverse events* and medication regiments. *An adverse event is considered serious if the event led, or might have led, to one of the following outcomes: 1. Death of a patient, USER or other person 2. Serious deterioration in state of health of a patient, USER or other person A serious deterioration in state of health can include: 1. Life-threatening illness 2. Permanent impairment of a body function or permanent damage to a body structure 3. A condition necessitating medical or surgical intervention to prevent point 1 or 2 immediately above 4. Any indirect harm as a consequence of an incorrect diagnostic or in vitro diagnostic medical devices (IVD) test results when used within manufacturer's instructions for use 5. Foetal distress, foetal death or any congenital abnormality or birth defects |
| Intervention type | Other |
| Primary outcome measure | 1. Safety: Freedom from all cause death, index limb amputation and target lesion revascularisation through 30 days 2. Efficacy: Target vessel patency defined as freedom from target lesion revascularisation caused by greater than 50% stenosis at 1 year |
| Secondary outcome measures | 1. Technical success defined as a successful access and deployment of the device with recanalisation determined by less than 30% residual stenosis by angiography at the baseline procedure, measured before discharge 2. Clinical success defined as technical success without the occurrence of serious adverse events during procedure, measured before discharge 3. Ankle Brachial Index improvement at 30 days and 1 year 4. Improvement of the Rutherford Index at 30 days and 1 year 5. Walking distance at 30 days and 1 year compared with walking distance before procedure (if Treadmill Test available) 6. Clinically driven Target Vessel Revascularisation at 1 year 7. Major complications at 1 year, (death (CV cause), index limb amputation and target lesion revascularisation within 1 year 8. Vascular complications, measured before discharge 9. Bleeding complications, measured before discharge 10. Improvement of quality of life at 30 days and 1 year |
| Overall study start date | 01/04/2009 |
| Overall study end date | 01/11/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2000 |
| Participant inclusion criteria | Patients aged greater than 18 years, either sex, that as per hospital practice are treated with a self-expanding nitinol stent |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 01/04/2009 |
| Recruitment end date | 01/11/2011 |
Locations
Countries of recruitment
- Austria
- Belgium
- Czech Republic
- Denmark
- Estonia
- France
- Germany
- Italy
- Netherlands
- Spain
- Sweden
- United Kingdom
Study participating centre
Terumo Europe N.V.
Leuven
B-3001
Belgium
B-3001
Belgium
Sponsor information
Terumo Europe N.V. (Belgium)
Industry
Industry
Research Park Zone 2, Haasrode
Interleuvenlaan 40
Leuven
B-3001
Belgium
| Phone | +32 (0)16 38 14 54 |
|---|---|
| vladimir.borovicanin@terumo-europe.com | |
| Website | http://www.terumo-europe.com |
"ROR" |
https://ror.org/043vk3t22 |
Funders
Funder type
Industry
Terumo Europe N.V. (Belgium) (ref: T112E2)
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 |
Editorial Notes
12/04/2017 No publications found in PubMed, verifying study status with principal investigator.
