Condition category
Circulatory System
Date applied
21/10/2009
Date assigned
30/11/2009
Last edited
04/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.terumo-europe.com

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

Publication citations

Additional files

Editorial Notes