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

• 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)

Study Overview

• Status: Unknown
• Conditions: Femoropopliteal Artery Disease
• Intervention / Treatment: Device: innova stent (Boston scientific)

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Recruiting
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Femoropopliteal artery disease

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
K-INNOVA; Patients with femoropopliteal artery disease undergoing endovascular therapy using Innova stent (Boston Scientific).	Device: innova stent (Boston scientific)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary patency rate	Absence of restenosis >50%	12 months after the index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion revascularization rate		12 months
Stent fracture rate		12 months
Quality of life	Quality of life by standardized questionnaires	12 months

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: February 29, 2016
• First Submitted That Met QC Criteria: March 7, 2016
• First Posted (ESTIMATE): March 8, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2020
• Last Update Submitted That Met QC Criteria: September 25, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Peripheral Artery Disease; Restenosis; Nitinol Stent; Femoropopliteal Artery
• Other Study ID Numbers: 1-2015-0074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO