Contact information
Type
Scientific
Primary contact
Dr Vladimir Borovicanin
ORCID ID
Contact details
Terumo Europe N.V.
European Medical and Clinical Division
Research Park Zone 2
Haasrode
Interleuvenlaan 40
Leuven
B-3001
Belgium
+32 (0)16 38 14 54
vladimir.borovicanin@terumo-europe.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
T112E2
Study information
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
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
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.
Study design
Observational non-randomised single-arm prospective multicentre study
Primary study design
Observational
Secondary study design
Multi-centre
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/04/2009
Overall trial end date
01/11/2011
Reason abandoned
Eligibility
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 type
Patient
Age group
Adult
Gender
Both
Target number of participants
2000
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
Trial participating centre
Terumo Europe N.V.
Leuven
B-3001
Belgium
Sponsor information
Organisation
Terumo Europe N.V. (Belgium)
Sponsor details
Research Park Zone 2
Haasrode
Interleuvenlaan 40
Leuven
B-3001
Belgium
+32 (0)16 38 14 54
vladimir.borovicanin@terumo-europe.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Terumo Europe N.V. (Belgium) (ref: T112E2)
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