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

September 25, 2020 updated by: Yonsei University
  • 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

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 12 months after the index procedure
Absence of restenosis >50%
12 months after the index procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 1-2015-0074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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