Prospective, non-randomised, multi-centre, observational study to confirm the performance of Misago® peripheral self-expanding stent system for the treatment of occluded or stenotic superficial femoral or popliteal arteries

ISRCTN	ISRCTN58138617
DOI	https://doi.org/10.1186/ISRCTN58138617
Secondary identifying numbers	T108E2

Submission date: 08/05/2008
Registration date: 05/06/2008
Last edited: 21/04/2011

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 Vladimir Borovicanin
Scientific

Terumo Europe N.V.
European Clinical Division
Research Park Zone 2, Haasrode
Interleuvenlaan 40
Leuven
B-3001
Belgium

Phone	+32 (0)16 38 14 54
Email	vladimir.borovicanin@terumo-europe.com

Study information

Study design	Observational, single arm, prospective multi-centre study
Primary study design	Observational
Secondary study design	Cross-section survey
Study setting(s)	Not specified
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
Study acronym	MISAGO 2
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/04/2008
Completion date	01/10/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	500
Key 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
Key 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
Date of first enrolment	01/04/2008
Date of final enrolment	01/10/2009

Locations

Countries of recruitment

Austria
Belarus
Belgium
Czech Republic
Denmark
France
Germany
Greece
Israel
Italy
Netherlands
Spain
Sweden
United Kingdom

Study participating centre

Terumo Europe N.V.

Leuven
B-3001
Belgium

Sponsor information

Terumo Europe N.V. (Belgium)
Industry

Research Park Zone 2, Haasrode
Interleuvenlaan 40
Leuven
B-3001
Belgium

Phone	+32 (0)16 38 14 54
Email	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: T108E2)

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	results	01/01/2010		Yes	No