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

NCT02701816 | Unknown

• 1 other identifier: 1-2015-0074
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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)

Conditions

Femoropopliteal Artery Disease

Keywords

Peripheral Artery Disease; Femoropopliteal Artery; Nitinol Stent; Restenosis

Outcome Measures

Primary Outcomes (1)

• Primary patency rate

  Absence of restenosis \>50%

  12 months after the index procedure

Secondary Outcomes (3)

• Target lesion revascularization rate

  12 months

• Stent fracture rate

  12 months

• Quality of life

  12 months

Study Arms (1)

K-INNOVA

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

Device: innova stent (Boston scientific)

Interventions

innova stent (Boston scientific) DEVICE

K-INNOVA

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Femoropopliteal artery disease

You may qualify if:

• Age 19 years of older
• Symptomatic peripheral artery disease:
• Moderate or severe claudication (Rutherford category 2 or 3)
• Critical limb ischemia (Rutherford category 4-5)
• Femoropopliteal artery lesions with stenosis \> 50%
• ABI \< 0.9
• Patients with signed informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 8, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)