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

NCT02701816 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2020-09-28

No results posted yet for this study

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

Interventions

DEVICE

innova stent (Boston scientific)

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Eligibility

Min Age
19 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2021-01-31
Completion
2021-01-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02701816 on ClinicalTrials.gov