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Korean Multicenter Prospective Registry of In.PACT DEB for Isolated Popliteal Artery Disease (K-POP Study)

NCT02698345 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-01-18

No results posted yet for this study

Summary

* Prospective, multi-center, single-arm registry study
* A total of 100 subjects with isolated popliteal artery lesions according to inclusion and exclusion criteria will be enrolled.
* All popliteal artery lesions will be treated with drug-eluting balloon (In.PACT Admiral, Medtronic). • Atherectomy or use of bare nitinol stent in combination with drug-eluting balloon is allowed • Patients will be followed clinically for 12 months after the procedure.
* Imaging study (Duplex ultrasound, CT angiography or catheter angiography) follow-up will be performed at 12 months.

Conditions

  • Popliteal Artery Disease

Interventions

DEVICE

drug-eluting balloon (In.PACT Admiral, Medtronic)

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
2021-03-31
Completion
2021-03-31

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 NCT02698345 on ClinicalTrials.gov