Safety and efficacy of the Misago® peripheral self-expanding stent system in real-world patients

Prospective, non-randomised, multicentre, observational study to further support safety and efficacy of the Misago® peripheral self-expanding stent system in real-world patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN57930977

Enrollment

2000

Registered

2009-11-30

Start date

2009-04-01

Completion date

Unknown

Last updated

2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Occluded or stenotic iliac, superficial femoral and/or popliteal arteries Circulatory System Other peripheral vascular diseases

Interventions

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 s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged greater than 18 years, either sex, that as per hospital practice are treated with a self-expanding nitinol stent

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Austria, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026