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

Femoropopliteal Artery Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02701816
• Other study ID #: 1-2015-0074
• Status: Recruiting
• Start date: January 2016
• Est. completion date: January 2021

Study information

• Verified date: September 2020
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Femoropopliteal Artery Disease

Intervention

Device:
• innova stent (Boston scientific)

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency rate	Absence of restenosis >50%	12 months after the index procedure
Secondary	Target lesion revascularization rate		12 months
Secondary	Stent fracture rate		12 months
Secondary	Quality of life	Quality of life by standardized questionnaires	12 months