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 of protocol

Not provided at time of registration

Contact information

Dr Vladimir Borovicanin
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
Email	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 objectives	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.
Health condition(s) or problem(s) studied	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
Completion date	01/11/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	2000
Key inclusion criteria	Patients aged greater than 18 years, either sex, that as per hospital practice are treated with a self-expanding nitinol stent
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/04/2009
Date of final enrolment	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

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: 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.