Korean Multicenter Registry of INNOVA Stent for Femoropopliteal Artery Disease: (K-INNOVA Registry)

Yonsei University

Status: Unknown

Conditions: Femoropopliteal Artery Disease

Treatments: Device: innova stent (Boston scientific)

Study type: Observational

Funder types: Other

Identifiers

NCT02701816

1-2015-0074

Details and patient eligibility

About

• Prospective, single-arm, multi-center registry study
• A total of 150 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included.
• Patients will be followed clinically for 12 months after the procedure.
• Duplex ultrasound, CT or catheter-based angiography follow-up according to participating hospital's protocol will be performed at 12 months.
• Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12 months.
• Quality of life by standardized questionnaires (at baseline & at 1 & 12 months)

Enrollment: 150 estimated patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 19 years of older

2. Symptomatic peripheral artery disease:

   • Moderate or severe claudication (Rutherford category 2 or 3)
   • Critical limb ischemia (Rutherford category 4-5)

3. Femoropopliteal artery lesions with stenosis > 50%

4. ABI < 0.9

5. Patients with signed informed consent

Exclusion criteria

1. Acute critical limb ischemia
2. Severe critical limb ischemia (Rutherford category 6)
3. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
4. In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to the enrollment)
5. Bypass graft lesions
6. Age > 85 years
7. Severe hepatic dysfunction (> 3 times normal reference values)
8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
9. LVEF < 40% or clinically overt congestive heart failure
10. Pregnant women or women with potential childbearing
11. Life expectancy <1 year due to comorbidity
12. Untreated proximal inflow disease of the ipsilateral iliac arteries (more than 50% stenosis or occlusion)

Trial design

150 participants in 1 patient group

K-INNOVA

Description:

Patients with femoropopliteal artery disease undergoing endovascular therapy using Innova stent (Boston Scientific).

Treatment:

Device: innova stent (Boston scientific)