NCT02698345

Unknown

Korean Multicenter Prospective Registry of In.PACT DEB for I...

Yonsei University Source

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Other study identifiers

Sponsor study identifier

1-2015-0081

Study Type

observational

Estimated enrollment

100

Locations

1 country

Sites

1

Timeline

Study Start

January 2016

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

March 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 100 participants
Study completion date: March 2021
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2016
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
February 29, 2016
Actual (reported)
First Posted
March 3, 2016
Actual (reported)
Primary Completion
March 2021
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2021
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: January 18, 2019
Status Verified: January 2019
Last Update Submitted: January 16, 2019

Conditions

Popliteal Artery Disease

Keywords

Popliteal artery disease, drug-eluting balloon, angioplasty

Outcome Measures

Primary Outcomes (1)

Primary patency rate
absence of restenosis \>50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months
12 months after the index procedure

Secondary Outcomes (1)

Target vessel revascularization rate
12 months

Study Arms (1)

K-POP

Patients with isolated popliteal artery disease undergoing endovascular therapy using drug-eluting balloon (In.PACT Admiral, Medtronic)

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

Interventions

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

K-POP

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age19 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with isolated popliteal artery disease

You may qualify if:

Age 19 years or older

Sponsors & Collaborators

Yonsei University
Otherlead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

Young-Guk Ko, MDCONTACT82-2-2228-8460 ygko@yuhs.ac

Hyuck-Moon Kwon, MD, Ph.DCONTACT82-2-2019-3310 kwonhm@yuhs.ac

Related Publications (1)

Park JI, Ko YG, Lee SJ, Ahn CM, Rha SW, Yu CW, Park JK, Park SH, Lee JH, Kim SH, Lee YJ, Hong SJ, Kim JS, Kim BK, Hong MK, Choi D. Clinical Outcomes After Drug-Coated Balloon Treatment in Popliteal Artery Disease: K-POP Registry 12-Month Results. Korean Circ J. 2024 Aug;54(8):454-465. doi: 10.4070/kcj.2024.0006. Epub 2024 Apr 29.
PMID: 38767445DERIVED

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 3, 2016

Study Start

January 2016

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2021

Estimated (date passed)

Symptomatic peripheral artery disease:

Moderate or severe claudication (Rutherford category 2 or 3)

Critical limb ischemia (Rutherford category 4 or 5)

Atherosclerotic popliteal artery disease (stenosis \> 50%)

Patients with signed informed consent

You may not qualify if:

Acute critical limb ischemia
Severe critical limb ischemia (Rutherford category 6)
Involvement of SFA disease with stenosis
Continous total occlusion of all proximal infrapopliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk).
Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agent
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
Previous bypass surgery or stenting for the target popliteal artery
Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

March 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

January 18, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02698345
Data provider: ClinicalTrials.gov
Source updated: 2019-01-18
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:28 UTC

Locations

KR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

K-POP

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations