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

• Conditions: Femoropopliteal Artery Disease
• Interventions: Device: innova stent (Boston scientific)

• Registration Number: NCT02701816
• Lead Sponsor: Yonsei University

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-29
• Study First Submitted QC: 2016-03-07
• Study First Posted: 2016-03-08
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-25
• Last Update Posted: 2020-09-28
• Primary Completion: 2021-01
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
K-INNOVA	innova stent (Boston scientific)	Patients with femoropopliteal artery disease undergoing endovascular therapy using Innova stent (Boston Scientific).

Primary Outcome Measures

Name	Time	Method
Primary patency rate	12 months after the index procedure	Absence of restenosis \>50%

Secondary Outcome Measures

Name	Time	Method
Stent fracture rate	12 months
Quality of life	12 months	Quality of life by standardized questionnaires
Target lesion revascularization rate	12 months

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of