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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02698345
Recruitment Status : Recruiting
First Posted : March 3, 2016
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment
Popliteal Artery Disease Device: drug-eluting balloon (In.PACT Admiral, Medtronic)

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : January 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Group/Cohort Intervention/treatment
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)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Target vessel revascularization rate [ Time Frame: 12 months ]
    frequency of repeat intervention or surgical treatment due to loss of patency at the target vessel



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with isolated popliteal artery disease
Criteria

Inclusion Criteria:

  1. Age 19 years or older
  2. Symptomatic peripheral artery disease:

    • Moderate or severe claudication (Rutherford category 2 or 3)
    • Critical limb ischemia (Rutherford category 4 or 5)
  3. Atherosclerotic popliteal artery disease (stenosis > 50%)
  4. Patients with signed informed consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698345


Locations
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Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Young-Guk Ko, MD    82-2-2228-8460    ygko@yuhs.ac   
Contact: Hyuck-Moon Kwon, MD, Ph.D    82-2-2019-3310    kwonhm@yuhs.ac   
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02698345    
Other Study ID Numbers: 1-2015-0081
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yonsei University:
Popliteal artery disease, drug-eluting balloon, angioplasty