Contact information
Type
Scientific
Primary contact
Dr Vladimir Borovicanin
ORCID ID
Contact details
Terumo Europe N.V.
European 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
T108E2
Study information
Scientific title
Acronym
MISAGO 2
Study hypothesis
The objective of the registry is to confirm the performance and long term safety of Misago® peripheral self-expanding stent system for the treatment of occluded or stenotic superficial femoral or popliteal arteries in daily practice.
The rationale is that the Misago® self-expandable stent would show similar characteristics in comparison with new generation of nitinol self-expanding stents when tested on larger number of subjects.
Ethics approval
Ethics approval received from:
1. Freiburger ethik kommission International (Germany) on the 3rd March 2008
2. Ethik Komission Fachbereich Medizin der Johann Wolfgang Goethe - Universitaet Frankfurt a Mein (Germany) on the 29th April 2008
3. Ethik Kommission der Aerztekammer Westfallen-Lippe und der Medizinischen Fakultaet der Westfaelishen Wilhelms-Universitaet Muenster (Germany) on the 24th April 2008
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 July 2008.
Study design
Observational, single arm, prospective multi-centre study
Primary study design
Observational
Secondary study design
Cross-section survey
Trial setting
Not specified
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 superficial femoral and/or popliteal arteries
Intervention
Observational collection of routine hospital practice, 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 1. or 2.
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
Drug
Phase
Not Specified
Drug names
Misago® peripheral self-expanding stent
Primary outcome measure
Absence of clinically driven target lesion revascularisation at 6 and 12 months.
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
2. Clinical success defined as technical success without the occurrence of serious adverse events during procedure
3. Ankle-Brachial Index (ABI) improvement of greater than or equal to 0.1 (ABI before procedure compared with ABI at discharge and at 6 and 12 months)
4. Primary and secondary patency rate (if duplex ultrasound available) defined as less than 50% diameter reduction and peak systolic velocity less than 2.4
5. Improvement of walking distance at discharge and at 6 and 12 months compared with walking distance before procedure (if treadmill test available)
6. Clinically driven target vessel revascularisation at 6 and 12 months
7. Major complications at 6 and 12 months, including amputation of the distal part of the foot, the leg below the knee and the thigh
8. Vascular complications
9. Bleeding complications
10. The Rutherford classification of chronic limb ischaemia at discharge and at 6 and 12 months post-procedure
11. Stent fracture at 6 and 12 months post-procedure
Overall trial start date
01/04/2008
Overall trial end date
01/10/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients must fulfil all of the following criteria:
1. Patients with symptomatic one or two legs ischaemia, requiring treatment of superficial femoral artery (SFA) or popliteal artery (two or more by Rutherford classification)
2. Single lesions per leg with recoiling/dissection/restenosis after balloon angioplasty or de novo lesions with stenosis or occlusion, which can be covered by maximum two stents
3. Target vessel reference diameter greater than or equal to 4 mm and less than or equal to 6 mm (by visual estimate)
4. Target lesion length should consider that maximum two Misago® stents can be implanted per lesion with recommended overlap of 2 mm
5. At least one patent (less than 50% stenosis) tibioperoneal run-off vessel confirmed by baseline angiography
6. Patient is suitable candidate for femoral-popliteal artery bypass surgery
7. Aged 18 years or older, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant exclusion criteria
Patients with any of the following should be excluded:
1. Pregnancy
2. Previous bypass surgery or stenting in the target vessel
3. Scheduled staged procedure of multiple lesions within the ipsilateral iliac or popliteal arteries within 30 days after index procedure
4. Co-existing aneurismal disease of the abdominal aorta, iliac or popliteal arteries
5. Acute thrombophlebitis or deep venous thrombosis
6. Haemodynamic instability
7. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)
8. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
9. Known intolerance to study medications, contrast agents or nitinol
Recruitment start date
01/04/2008
Recruitment end date
01/10/2009
Locations
Countries of recruitment
Austria, Belarus, Belgium, Czech Republic, Denmark, France, Germany, Greece, Israel, 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: T108E2)
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
Basic results (scientific)
Publication list
2010 results in: Schulte K, et al. Misago2 6-month clinical outcome from the large multicentric study of Terumo-Misago peripheral stent. EuroIntervetion. Vol 6, Supp H, May 2010