Popliteal Artery DiseaseNCT02698345
Korean Multicenter Prospective Registry of In.PACT DEB for Isolated Popliteal Artery Disease (K-POP Study)
An observational study of Popliteal Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Popliteal Artery Disease
- What is being tested?
- drug-eluting balloon (In.PACT Admiral, Medtronic)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with isolated popliteal artery disease
Who may be able to join
- Age 19 years or older
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, 120-752
Young-Guk Ko, MD, 82-2-2228-8460, ygko@yuhs.ac
Hyuck-Moon Kwon, MD, Ph.D, 82-2-2019-3310, kwonhm@yuhs.ac
About this study
- 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
- Being tested
- drug-eluting balloon (In.PACT Admiral, Medtronic)
- Keywords
- Popliteal artery disease, drug-eluting balloon, angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug-eluting balloon (In.PACT Admiral, Medtronic)Device
| Study group | Role | What they receive |
|---|---|---|
| K-POP | Patients with isolated popliteal artery disease undergoing endovascular therapy using drug-eluting balloon (In.PACT Admiral, Medtronic) Receives: Device: drug-eluting balloon (In.PACT Admiral, Medtronic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency rate
absence of restenosis >50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months
Measured: 12 months after the index procedure
Secondary outcomes (1)
Target vessel revascularization rate
frequency of repeat intervention or surgical treatment due to loss of patency at the target vessel
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Popliteal Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698345
- Sponsor's protocol ID
- 1-2015-0081
- Status last verified
- Jan 2019
- First submitted
- 29 Feb 2016
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 38767445
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korean Multicenter Prospective Registry of In.PACT DEB for Isolated Popliteal Artery Disease (K-POP Study)
- ClinicalTrials.gov ID
- NCT02698345
- Acronym / sponsor ID
- 1-2015-0081
- Conditions
- Popliteal Artery Disease
- Keywords
- Popliteal artery disease, drug-eluting balloon, angioplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| K-POP | – | Device: drug-eluting balloon (In.PACT Admiral, Medtronic)Patients with isolated popliteal artery disease undergoing endovascular therapy using drug-eluting balloon (In.PACT Admiral, Medtronic) |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with isolated popliteal artery disease
Key inclusion criteria (6 listed)
- Age 19 years or older
- Symptomatic peripheral artery disease:
- Atherosclerotic popliteal artery disease (stenosis > 50%)
- Patients with signed informed consent
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drug-eluting balloon (In.PACT Admiral, Medtronic) | Device | K-POP |
Primary outcome
Primary patency rate
Time frame: 12 months after the index procedure
absence of restenosis >50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months
1 secondary outcome
Target vessel revascularization rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Derived from this study: PubMed 38767445Park 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.
- Individual participant dataSharing planned: No
Related trials for Popliteal Artery Disease
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Active, not recruiting
First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease
Superficial Femoral Artery Stenosis, Popliteal Artery Stenosis
Active, not recruitingObservational study
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Peripheral Artery Disease, Popliteal Aneurysm
Not yet recruitingObservational study
Surgical Treatment of Functional Popliteal Artery Entrapment Syndrome: Short- and Mid-Term Results
Popliteal Artery Entrapment Syndrome
Not yet recruitingPhase 2/3
A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.
Popliteal Artery Disease, Superficial Femoral Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Popliteal Artery Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency rate (time frame: 12 months after the index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02698345, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2019.