Prospective, Non-randomized, Multicentre, Observational Registry To confirm the performance of Misago Peripheral Self-Expanding Stent System for the Treatment of Occluded or Stenotic Superficial Femoral or Popliteal Arteries.

Prospective, Non-randomized, Multicentre, Observational Registry To confirm the performance of Misago Peripheral Self-Expanding Stent System for the Treatment of Occluded or Stenotic Superficial Femoral or Popliteal Arteries. - Misago-2 registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON32020

Enrollment

Registered

2008-06-13

Start date

2008-06-26

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

blockage of arteries occlusion stenosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with documented symptomatic occlusion and/or >70% stenosis of SFA or popliteal artery in one or both legs;1. Patients with symptomatic one or two legs ischemia, requiring treatment of SFA or popliteal artery (2 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 >=4mm and

Exclusion criteria

Exclusion criteria: Patient 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. Hemodynamic instability 7. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50 percent stenosis or occlusion), 8. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy 9. Known

Design outcomes

Primary

Measure	Time frame
Absence of clinically driven target lesion revascularization at 6 and 12 months	—

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 2. Clinical success defined as technical success without the occurrence of serious adverse events during procedure 3. Ankle-Brachial Index improvement of >= 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	—

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 2. Clinical success defined as technical success without the occurrence of serious adverse events during procedure 3. Ankle-Brachial Index improvement of >= 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

—

Countries

Netherlands

Outcome results